Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-08 @ 6:33 AM
Study NCT ID:
NCT05571033
Status:
RECRUITING
Last Update Posted:
2023-09-26
First Post:
2022-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D012021', 'term': 'Reflex, Abnormal'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each participant will serve as their own control.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2022-10-02', 'studyFirstSubmitQcDate': '2022-10-04', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Soleus H-Reflex size', 'timeFrame': 'Within one week before first intervention session to within one week after the end of intervention', 'description': 'Size of h-reflex as measured by EMG'}, {'measure': 'Attendance', 'timeFrame': 'At the end of the intervention, we will count the number of sessions each participant completed', 'description': 'Measure of feasibility of protocol, whether or not people can attend all sessions'}], 'secondaryOutcomes': [{'measure': '10 meter walk test', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'Measure of how long it takes the participant to walk 10 meters'}, {'measure': '6 minute walk test', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'Measure the distance a participant can walk in 6 min'}, {'measure': 'Fugl-Meyer', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'Standardized test of motor skill, range of motion, and spasticity'}, {'measure': 'Modified Ashworth Scale', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'Measure of muscle spasticity in leg muscles'}, {'measure': 'Range of motion', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'Measure of flexibility of leg joints'}, {'measure': 'Fatigue Severity Scale', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'A survey of fatigue symptoms'}, {'measure': 'Berg Balance Scale', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': "Measure of participant's ability to balance"}, {'measure': 'Timed up and Go', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'Measure of how quickly a participant can stand from a chair, walk, return to chair, and sit'}, {'measure': 'Sit to Stand Test', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'Time it takes for a participant can stand up five times in a row'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) Anxiety question bank', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about anxiety'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) Fatigue question bank', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about fatigue'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) Depression question bank', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about depression'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) General Life Satisfaction question bank', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about General Life Satisfaction'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) General Self Efficacy question bank', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about General Self Efficacy'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) Meaning and Purpose question bank', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about Meaning and Purpose'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) Self-Efficacy for Managing Chronic Conditions question bank', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about Self-Efficacy for Managing Chronic Conditions'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) Sleep Disturbances question bank', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about sleep'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) Pain Interference question bank', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about pain'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) Ability to Participate in Social Roles and Activities question bank', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about Ability to Participate in Social Roles and Activities'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) Physical Function', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about physical functioning'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) Satisfaction with Social Roles and Activities', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about Satisfaction with Social Roles and Activities'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) Mobility question bank', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about mobility'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) Social Isolation question bank', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about isolation'}, {'measure': 'Patient Reported Outcome Measures (PROMIS) Upper Extremity question bank', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'computer-based survey for participants to answer questions about hand and arm function'}, {'measure': 'Change in size of motor evoked potential in the brain', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'Using single pulse transcranial magnetic stimulation, we will measure the amount of energy required to evoke a leg muscle movement from a stimulus delivered to the head'}, {'measure': 'Manual Ability Classification System', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'A categorical measure of how well a participant can move their hands'}, {'measure': 'Jebsen-Taylor Test of Hand Function', 'timeFrame': 'Within one week before the first intervention session to within one week after the end of intervention', 'description': 'A timed test that measures how quickly the participant can move checkers, cans, and small objects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hoffman Reflex', 'Spinal Reflex Conditioning'], 'conditions': ['Cerebral Palsy', 'Spastic Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '23281107', 'type': 'BACKGROUND', 'citation': 'Thompson AK, Chen XY, Wolpaw JR. Soleus H-reflex operant conditioning changes the H-reflex recruitment curve. Muscle Nerve. 2013 Apr;47(4):539-44. doi: 10.1002/mus.23620. Epub 2012 Dec 21.'}, {'pmid': '31166816', 'type': 'BACKGROUND', 'citation': 'Mrachacz-Kersting N, Kersting UG, de Brito Silva P, Makihara Y, Arendt-Nielsen L, Sinkjaer T, Thompson AK. Acquisition of a simple motor skill: task-dependent adaptation and long-term changes in the human soleus stretch reflex. J Neurophysiol. 2019 Jul 1;122(1):435-446. doi: 10.1152/jn.00211.2019. Epub 2019 Jun 5.'}]}, 'descriptionModule': {'briefSummary': '12 adults with spastic CP will complete 6 baseline sessions and 24 down conditioning sessions held 3 times/week. All clinical and physiological assessments collected at baseline will be reassessed after study completion, and follow ups after 2 weeks, 1 month and 3 months. The soleus H reflex (electric analogue of the stretch reflex) will be elicited in all sessions. In each session, participants will complete 20 baseline trials and 225 down conditioning trials to decrease the magnitude of the H-Reflex.', 'detailedDescription': 'Individuals with CP face significant challenges due to spasticity that causes activity and participation restrictions with increase in secondary conditions. This is caused by injury to the upper motor neurons causing disruption to the neural circuitry responsible for maintaining motor tone. A novel intervention, OC of the H reflex has shown promising effects to reduce spasticity and improve motor function in people with stroke and spinal cord. Its many known benefits include easy administration, non-invasive technique, no side effects, and long-term retention. In the study, the investigators will attempt to decrease the increased muscle tone of individuals with CP. If successful, it will not only provide evidence for future clinical application but also broaden the scope for alternate or supplementary non-invasive treatment approaches to decrease spasticity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 and above\n2. Diagnosis of spastic Cerebral Palsy\n3. Gross Motor Function Classification System level I-III\n4. Stable medical background\n5. Current medication will remain unchanged for 3 months\n6. Provides informed consent\n7. can walk at least 10 meters with or without assistive device\n8. meets minimum study procedure requirements (elicitation of H-reflex).\n\nExclusion Criteria:\n\n1. Pregnancy\n2. uncontrolled diabetes\n3. weak dorsiflexion\n4. History of cardiac conditions\n5. cognitive deficits that interfere with study procedure and steps for completion\n6. Botox within 2 months of the study\n7. H/O ankle surgeries in affected leg (Dorsal root rhizotomy etc.)\n8. regular use of electrical stimulation to lower extremity muscles\n9. Cochlear or metal implantations on body\n10. No history of seizure after age 2 years\n11. Current use of antiseizure medicines\n12. Any metal or magnetic components in the head (surgical clips, metal work etc.)\n13. Implanted device or cardiac pacemakers (applicable for DS8R too)\n14. Skin disorders\n15. Damaged skin (wounds, broken skin, or recent scar tissue)\n16. Allergy to latex (tape)'}, 'identificationModule': {'nctId': 'NCT05571033', 'acronym': 'SRC-CP', 'briefTitle': 'Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Burke Medical Research Institute'}, 'officialTitle': 'Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'SRC-CP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spinal reflex conditioning', 'description': 'The OC intervention includes 6 baseline sessions and 24 conditioning/ no conditioning sessions held 3 times/week.\n\nTo elicit an H-reflex, participants will be asked to stand in a comfortable position. Small pulses of energy will be applied to a nerve in the leg called the tibial nerve. We will record when the participant maintains leg muscle activity. During the intervention, participants will be trained to decrease their reflex in their calf.', 'interventionNames': ['Behavioral: Spinal reflex conditioning']}], 'interventions': [{'name': 'Spinal reflex conditioning', 'type': 'BEHAVIORAL', 'description': 'Each participant will serve as their own control. The intervention is 30 sessions. The first 6 sessions are baseline measures of reflexes. The remaining sessions will engage participants in learning how to decrease their reflex activity in their calf muscle on the more-affected leg. Each intervention visit will involve 20 trials in which participants do not get visual feedback about their performance, then 225 trials with visual feedback.', 'armGroupLabels': ['Spinal reflex conditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10605', 'city': 'White Plains', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathleen Friel, PhD', 'role': 'CONTACT', 'email': 'kaf3001@med.cornell.edu', 'phone': '914-368-3116'}, {'name': 'Kathleen Friel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Burke Neurological Institute', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}], 'centralContacts': [{'name': 'Devina Kumar, PhD', 'role': 'CONTACT', 'email': 'dek4004@med.cornell.edu', 'phone': '914-368-3160'}], 'overallOfficials': [{'name': 'Kathleen Friel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Burke Neurological Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available as soon as the findings are published, and will be available indefinitely.', 'ipdSharing': 'YES', 'description': 'We will email deidentified datasets to other researchers upon request. When we publish our results, we will mention in the paper(s) that the dataset is fully available via email.', 'accessCriteria': 'We will provide data to researchers who have experience with operant conditioning data analyses.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Burke Medical Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}