Ignite Creation Date:
2025-12-24 @ 12:51 PM
Ignite Modification Date:
2026-01-28 @ 2:54 PM
Study NCT ID:
NCT02268461
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2014-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Post-Stroke Spasticity
Sponsor:
Organization:
Raw JSON
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One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham', 'description': 'Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS)\n\nSham repetitive Transcranial Magnetic Stimulation: Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Contralesional Corticospinal Excitability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rTMS', 'description': 'repetitive Transcranial Magnetic Stimulation (rTMS)\n\nrepetitive Transcranial Magnetic Stimulation (rTMS): The treatment arm will consist of 3 daily treatment sessions. 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The average amplitude of 10 MEPs measured at baseline was compared to the average of 10 MEPs measured at post-test and this difference is recorded as the change in corticospinal excitability. A greater negative value would indicate larger post-test MEPs and increased corticospinal excitability.', 'unitOfMeasure': 'microVolts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Finger Tracking Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rTMS', 'description': 'repetitive Transcranial Magnetic Stimulation (rTMS)\n\nrepetitive Transcranial Magnetic Stimulation (rTMS): The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS)\n\nSham repetitive Transcranial Magnetic Stimulation: Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.95', 'spread': '29.65', 'groupId': 'OG000'}, {'value': '8.01', 'spread': '27.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 5', 'description': 'An electrogoniometer attached to the hand was used to measure index finger movement. Patients tracked a sine wave that ranged from 85% to 15% of their individual max range of motion which does impact the accuracy measure scale. Accuracy of tracking along with the target waveform was assessed on a scale ranging from -100 to 100 (100 being perfect accuracy).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Stroke Impact Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rTMS', 'description': 'repetitive Transcranial Magnetic Stimulation (rTMS)\n\nrepetitive Transcranial Magnetic Stimulation (rTMS): The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS)\n\nSham repetitive Transcranial Magnetic Stimulation: Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.433', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 5', 'description': "Change from baseline stroke impact scale score The Stroke Impact Scale (SIS) is a standardized self-reported questionnaire used to assess the impact of stoke on an individual's quality of life.\n\nScores range from 0-100 with higher scores indicating greater functionality and quality of life.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Resting Motor Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rTMS', 'description': 'repetitive Transcranial Magnetic Stimulation (rTMS)\n\nrepetitive Transcranial Magnetic Stimulation (rTMS): The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS)\n\nSham repetitive Transcranial Magnetic Stimulation: Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.25', 'spread': '4.49', 'groupId': 'OG000'}, {'value': '-3.75', 'spread': '12.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 5', 'description': 'Average change from baseline resting motor threshold The resting motor threshold (RMT) is the lowest possible stimulator output (% maximal stimulator output) required to reliably elicit a motor evoked potential. A lower RMT would indicate increased corticospinal excitability.', 'unitOfMeasure': '%MSO', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'rTMS Then Sham rTMS', 'description': 'repetitive Transcranial Magnetic Stimulation (rTMS)\n\nrepetitive Transcranial Magnetic Stimulation (rTMS): The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.'}, {'id': 'FG001', 'title': 'Sham rTMS Then Real rTMS', 'description': 'Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS)\n\nSham repetitive Transcranial Magnetic Stimulation: Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'rTMS Then Sham rTMS', 'description': 'repetitive Transcranial Magnetic Stimulation (rTMS)\n\nrepetitive Transcranial Magnetic Stimulation (rTMS): The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.'}, {'id': 'BG001', 'title': 'Sham rTMS Then Real rTMS', 'description': 'Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS)\n\nSham repetitive Transcranial Magnetic Stimulation: Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Data was not collected', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2014-09-09', 'resultsFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2014-10-15', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-23', 'studyFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline Contralesional Corticospinal Excitability', 'timeFrame': 'From Day 1 to Day 5', 'description': 'Motor evoked potentials (MEPs) were measured using surface EMG. The average amplitude of 10 MEPs measured at baseline was compared to the average of 10 MEPs measured at post-test and this difference is recorded as the change in corticospinal excitability. A greater negative value would indicate larger post-test MEPs and increased corticospinal excitability.'}, {'measure': 'Change From Baseline Finger Tracking Score', 'timeFrame': 'From Day 1 to Day 5', 'description': 'An electrogoniometer attached to the hand was used to measure index finger movement. Patients tracked a sine wave that ranged from 85% to 15% of their individual max range of motion which does impact the accuracy measure scale. Accuracy of tracking along with the target waveform was assessed on a scale ranging from -100 to 100 (100 being perfect accuracy).'}], 'secondaryOutcomes': [{'measure': 'Change in Stroke Impact Scale', 'timeFrame': 'From Day 1 to Day 5', 'description': "Change from baseline stroke impact scale score The Stroke Impact Scale (SIS) is a standardized self-reported questionnaire used to assess the impact of stoke on an individual's quality of life.\n\nScores range from 0-100 with higher scores indicating greater functionality and quality of life."}, {'measure': 'Change From Baseline Resting Motor Threshold', 'timeFrame': 'From Day 1 to Day 5', 'description': 'Average change from baseline resting motor threshold The resting motor threshold (RMT) is the lowest possible stimulator output (% maximal stimulator output) required to reliably elicit a motor evoked potential. A lower RMT would indicate increased corticospinal excitability.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Post-Stroke Spasticity'], 'conditions': ['Spasticity']}, 'referencesModule': {'references': [{'pmid': '14963280', 'type': 'BACKGROUND', 'citation': 'Carmichael ST, Tatsukawa K, Katsman D, Tsuyuguchi N, Kornblum HI. Evolution of diaschisis in a focal stroke model. Stroke. 2004 Mar;35(3):758-63. doi: 10.1161/01.STR.0000117235.11156.55. Epub 2004 Feb 12.'}, {'pmid': '17280510', 'type': 'BACKGROUND', 'citation': 'Duque J, Murase N, Celnik P, Hummel F, Harris-Love M, Mazzocchio R, Olivier E, Cohen LG. Intermanual Differences in movement-related interhemispheric inhibition. J Cogn Neurosci. 2007 Feb;19(2):204-13. doi: 10.1162/jocn.2007.19.2.204.'}, {'pmid': '14991818', 'type': 'BACKGROUND', 'citation': 'Murase N, Duque J, Mazzocchio R, Cohen LG. Influence of interhemispheric interactions on motor function in chronic stroke. Ann Neurol. 2004 Mar;55(3):400-9. doi: 10.1002/ana.10848.'}, {'pmid': '18455961', 'type': 'BACKGROUND', 'citation': 'Kirton A, Chen R, Friefeld S, Gunraj C, Pontigon AM, Deveber G. Contralesional repetitive transcranial magnetic stimulation for chronic hemiparesis in subcortical paediatric stroke: a randomised trial. Lancet Neurol. 2008 Jun;7(6):507-13. doi: 10.1016/S1474-4422(08)70096-6. Epub 2008 May 1.'}, {'pmid': '20005962', 'type': 'BACKGROUND', 'citation': 'Grefkes C, Nowak DA, Wang LE, Dafotakis M, Eickhoff SB, Fink GR. Modulating cortical connectivity in stroke patients by rTMS assessed with fMRI and dynamic causal modeling. Neuroimage. 2010 Mar;50(1):233-42. doi: 10.1016/j.neuroimage.2009.12.029. Epub 2009 Dec 18.'}, {'pmid': '9437276', 'type': 'BACKGROUND', 'citation': 'Burn J, Dennis M, Bamford J, Sandercock P, Wade D, Warlow C. Epileptic seizures after a first stroke: the Oxfordshire Community Stroke Project. BMJ. 1997 Dec 13;315(7122):1582-7. doi: 10.1136/bmj.315.7122.1582.'}, {'pmid': '11912111', 'type': 'BACKGROUND', 'citation': 'Carey JR, Kimberley TJ, Lewis SM, Auerbach EJ, Dorsey L, Rundquist P, Ugurbil K. Analysis of fMRI and finger tracking training in subjects with chronic stroke. Brain. 2002 Apr;125(Pt 4):773-88. doi: 10.1093/brain/awf091.'}, {'pmid': '17876070', 'type': 'BACKGROUND', 'citation': 'Carey JR, Evans CD, Anderson DC, Bhatt E, Nagpal A, Kimberley TJ, Pascual-Leone A. Safety of 6-Hz primed low-frequency rTMS in stroke. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):185-92. doi: 10.1177/1545968307305458. Epub 2007 Sep 17.'}, {'pmid': '22071503', 'type': 'BACKGROUND', 'citation': 'Kakuda W, Abo M, Momosaki R, Yokoi A, Fukuda A, Ito H, Tominaga A, Umemori T, Kameda Y. Combined therapeutic application of botulinum toxin type A, low-frequency rTMS, and intensive occupational therapy for post-stroke spastic upper limb hemiparesis. Eur J Phys Rehabil Med. 2012 Mar;48(1):47-55. Epub 2011 Nov 9.'}, {'pmid': '21456998', 'type': 'BACKGROUND', 'citation': 'Kakuda W, Abo M, Kobayashi K, Momosaki R, Yokoi A, Fukuda A, Ito H, Tominaga A, Umemori T, Kameda Y. Anti-spastic effect of low-frequency rTMS applied with occupational therapy in post-stroke patients with upper limb hemiparesis. Brain Inj. 2011;25(5):496-502. doi: 10.3109/02699052.2011.559610.'}, {'pmid': '20613547', 'type': 'BACKGROUND', 'citation': 'Kakuda W, Abo M, Kobayashi K, Momosaki R, Yokoi A, Fukuda A, Ishikawa A, Ito H, Tominaga A. Low-frequency repetitive transcranial magnetic stimulation and intensive occupational therapy for poststroke patients with upper limb hemiparesis: preliminary study of a 15-day protocol. Int J Rehabil Res. 2010 Dec;33(4):339-45. doi: 10.1097/MRR.0b013e32833cdf10.'}, {'pmid': '20537584', 'type': 'BACKGROUND', 'citation': 'Kirton A, Deveber G, Gunraj C, Chen R. Cortical excitability and interhemispheric inhibition after subcortical pediatric stroke: plastic organization and effects of rTMS. Clin Neurophysiol. 2010 Nov;121(11):1922-9. doi: 10.1016/j.clinph.2010.04.021.'}, {'pmid': '8120818', 'type': 'BACKGROUND', 'citation': 'Kujirai T, Caramia MD, Rothwell JC, Day BL, Thompson PD, Ferbert A, Wroe S, Asselman P, Marsden CD. Corticocortical inhibition in human motor cortex. J Physiol. 1993 Nov;471:501-19. doi: 10.1113/jphysiol.1993.sp019912.'}, {'pmid': '10727918', 'type': 'BACKGROUND', 'citation': 'Liepert J, Storch P, Fritsch A, Weiller C. Motor cortex disinhibition in acute stroke. Clin Neurophysiol. 2000 Apr;111(4):671-6. doi: 10.1016/s1388-2457(99)00312-0.'}, {'pmid': '18502315', 'type': 'BACKGROUND', 'citation': 'Mally J, Dinya E. Recovery of motor disability and spasticity in post-stroke after repetitive transcranial magnetic stimulation (rTMS). Brain Res Bull. 2008 Jul 1;76(4):388-95. doi: 10.1016/j.brainresbull.2007.11.019. Epub 2007 Dec 26.'}, {'pmid': '3160243', 'type': 'BACKGROUND', 'citation': 'Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.'}, {'type': 'BACKGROUND', 'citation': 'Mathiowetz V, Federman S, Wiemer, D. Box and Block Test of Manual Dexterity: Norms for 6-19 Year Olds. CJOT. 1985b; 52(5): 241-245.'}, {'pmid': '16489434', 'type': 'BACKGROUND', 'citation': 'McDonnell MN, Orekhov Y, Ziemann U. The role of GABA(B) receptors in intracortical inhibition in the human motor cortex. Exp Brain Res. 2006 Aug;173(1):86-93. doi: 10.1007/s00221-006-0365-2. Epub 2006 Feb 18.'}, {'pmid': '22179539', 'type': 'BACKGROUND', 'citation': 'Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.'}, {'pmid': '22760104', 'type': 'BACKGROUND', 'citation': 'Sommerfeld DK, Gripenstedt U, Welmer AK. Spasticity after stroke: an overview of prevalence, test instruments, and treatments. Am J Phys Med Rehabil. 2012 Sep;91(9):814-20. doi: 10.1097/PHM.0b013e31825f13a3.'}, {'pmid': '21524650', 'type': 'BACKGROUND', 'citation': 'Theilig S, Podubecka J, Bosl K, Wiederer R, Nowak DA. Functional neuromuscular stimulation to improve severe hand dysfunction after stroke: does inhibitory rTMS enhance therapeutic efficiency? Exp Neurol. 2011 Jul;230(1):149-55. doi: 10.1016/j.expneurol.2011.04.010. Epub 2011 Apr 16.'}, {'pmid': '9708852', 'type': 'BACKGROUND', 'citation': 'Wassermann EM, Wedegaertner FR, Ziemann U, George MS, Chen R. Crossed reduction of human motor cortex excitability by 1-Hz transcranial magnetic stimulation. Neurosci Lett. 1998 Jul 10;250(3):141-4. doi: 10.1016/s0304-3940(98)00437-6.'}, {'pmid': '21164121', 'type': 'BACKGROUND', 'citation': 'Weiduschat N, Thiel A, Rubi-Fessen I, Hartmann A, Kessler J, Merl P, Kracht L, Rommel T, Heiss WD. Effects of repetitive transcranial magnetic stimulation in aphasic stroke: a randomized controlled pilot study. Stroke. 2011 Feb;42(2):409-15. doi: 10.1161/STROKEAHA.110.597864. Epub 2010 Dec 16.'}, {'type': 'BACKGROUND', 'citation': 'Braddom, Randall L., Ralph M. Buschbacher. Ch 30 Spasticity Management. Physical Medicine & Rehabilitation. Saunders Elsevier 2007; 641-55.'}]}, 'descriptionModule': {'briefSummary': 'Spasticity is a common complication of stroke affecting quality of life. Spasticity involves exaggerated stretch reflexes that create stiffness in muscles with associated loss of motion and functional control. Traditional treatments involve range of motion, medications, and sometimes surgery. Each of these has its own limitations, which has invited exploration of alternative modes of treatment. One such treatment with the potential to benefit spasticity is repetitive Transcranial Magnetic Stimulation (rTMS).\n\nThe purpose of this study is to determine whether patients with upper limb spasticity as a consequence of a chronic stroke can benefit from stimulation of the non-affected hemisphere of the brain with low-frequency (inhibitory) repetitive Transcranial Magnetic Stimulation (rTMS), potentially leading to a reduction of spasticity and clinical improvement in upper limb function.', 'detailedDescription': 'The purpose of this pilot study is to evaluate the efficacy of rTMS versus placebo for spasticity reduction in a cross-over design in 6 people with stroke.\n\nOur research question is: In patients with upper extremity spasticity as a consequence of chronic stroke, does stimulation of the contralesional motor cortex with low-frequency (inhibitory) rTMS lead to reduction of spasticity and thereby clinical improvement in upper extremity function? Our rationale is that the pathophysiology of post-stroke spasticity is primarily driven by ensuant cortical derangement, and further, that this derangement can be mitigated to a clinically meaningful extent by proper utilization of rTMS directed at these foci. Optimized rTMS treatment protocols may even achieve efficacy that surpasses current mainstays of spasticity management.\n\nPatients will be randomly assigned to receive either rTMS or placebo during their first treatment arm and then cross-over to receive the opposite treatment at the second treatment arm. A washout period of one month will occur between treatment arms. Each treatment arm will consist of 3 daily treatment sessions. Participants will present on a Monday for the pre-test assessment, Tuesday-Thursday for the treatment sessions and Friday for the post-test assessment. One treatment session will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere. Sham rTMS intensity will be 0% but with a similar sound and scalp sensation. Assessments will be made at each session, and will be conducted at pre-test, post-test, and one-month follow-up. The one month follow-up test will serve as the pretest for the next treatment arm. That is, after follow-up, patients will cross-over to receive the opposite treatment in the same format. Safety has already been demonstrated for our protocol. Data will be analyzed with methods appropriate to a single-subject crossover design (visual analysis, confidence intervals and 2-Standard Deviation bandwidth).\n\nThe primary outcome that we will measure is reduction of spasticity at the fingers and wrist. A secondary outcome of interest is functional improvement of the spastic upper limb.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. first-time stroke\n2. stroke at least six months prior to onset of study with chronic sequela of spasticity\n3. stroke location- either cortical or subcortical\n4. stroke type- either hemorrhagic or ischemic\n5. stroke hemisphere- either left or right, dominant or non- dominant hemisphere\n6. 18 years of age or older\n7. gender- either male or female\n8. ability to follow three-step directions\n9. demonstration of 10 degrees of active extension at the metacarpophalangeal joint and wrist of the paretic upper extremity\n10. demonstration of consistent resting motor evoked potential from ipsilesional and contralesional hemispheres\n11. sufficient ambulation or wheelchair mobility to allow subject to present to treatment and testing areas with minimum assist\n\nExclusion Criteria:\n\n1. history of seizure within the past two years\n2. inability to follow three-step directions\n3. anosognosia\n4. moderate to severe receptive aphasia\n5. inability to give informed consent\n6. premorbid spasticity or neurologic impairment prior to stroke\n7. co-morbidities impairing upper extremity function such as fracture or deformity\n8. indwelling metal or medical devices incompatible with TMS\n9. pregnancy\n10. bi-hemispheric or multifocal stroke\n11. dementia\n12. neurolytic injection within the 3 months prior to onset of study or planned neurolytic injection during study period\n13. planned vacation or travel during study period'}, 'identificationModule': {'nctId': 'NCT02268461', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Post-Stroke Spasticity', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Post-Stroke Spasticity', 'orgStudyIdInfo': {'id': '1408M53261'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rTMS then Sham rTMS', 'description': 'repetitive Transcranial Magnetic Stimulation (rTMS)', 'interventionNames': ['Device: repetitive Transcranial Magnetic Stimulation (rTMS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham rTMS then Real rTMS', 'description': 'Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS)', 'interventionNames': ['Device: Sham repetitive Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'repetitive Transcranial Magnetic Stimulation (rTMS)', 'type': 'DEVICE', 'otherNames': ['Magstim 200^2 Magnetic Stimulator (MODEL 3010-00)', 'Magstim Rapid^2 Magnetic Stimulator (MODE 3004-000)'], 'description': 'The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.', 'armGroupLabels': ['rTMS then Sham rTMS']}, {'name': 'Sham repetitive Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': 'Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.', 'armGroupLabels': ['Sham rTMS then Real rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota, Clinical and Translational Science Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Matthew J Timp, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota, Physical Medicine and Rehabilitation'}, {'name': 'James R Carey, PhD, PT', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Minnesota, Program in Physical Therapy'}, {'name': 'Florence S John, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Minnesota, Physical Medicine and Rehabilitation'}, {'name': 'Kate Frost, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Minnesota, Program in Physical Therapy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}