Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-18 @ 1:25 PM
Study NCT ID:
NCT05410392
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2022-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedicine Intervention in Patients With Chronic Pain in PD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 166}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2022-06-02', 'studyFirstSubmitQcDate': '2022-06-02', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Severity', 'timeFrame': '3 months', 'description': 'Change in pain severity score from baseline to 3-month follow-up is the outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Pain'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "Pain is a very common and disabling symptom in Parkinson's disease, yet it is often untreated. This study will assess the impact of home-based physical and cognitive exercise interventions to reduce pain in this disease. This approach would offer an easily implemented and affordable way to encourage and maintain use of these interventions by patients virtually indefinitely through remote access technology. The study findings may help VA clinicians provide optimal care for the many Veterans with Parkinson's disease and chronic pain.", 'detailedDescription': "Project Background/Rationale: Pain is one of the most disabling and common nonmotor symptoms in Parkinson's disease (PD), with a prevalence of 40-85%. Research indicates that undertreatment of pain is particularly high in the PD population. Only about one-half of patients with PD who report pain receive regular pain medications. There is increasing interest in nonpharmacological treatments for chronic pain in PD to supplement pharmacological approaches. While there is evidence to support the utility of physical exercise to improve chronic pain management, relatively less is known about the role of cognitive exercise.\n\nProject Objective: The investigators propose to conduct a pilot randomized, controlled trial in patients with chronic pain in PD to assess the impact of physical and cognitive exercise interventions on pain outcomes.\n\nProject Methods: A total of 166 community-dwelling Veterans, 40 years of age or older, with chronic pain in mild-to-moderate PD will be randomly assigned in a 2 x 2 factorial design to one of four groups (1 - combined cognitive and physical intervention, 2 - physical intervention only, 3 - cognitive intervention only, 4 - health education). The investigators will test the effects of the interventions at 3 months for the outcome of pain severity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician diagnosis of idiopathic PD\n* At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)\n* Response to dopaminergic medication\n\nExclusion Criteria:\n\n* Angina pectoris\n* History of myocardial infarction (MI) within 6 months\n* History of ventricular dysrhythmia requiring current therapy'}, 'identificationModule': {'nctId': 'NCT05410392', 'briefTitle': 'Telemedicine Intervention in Patients With Chronic Pain in PD', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Telemedicine Intervention in Patients With Chronic Pain in PD', 'orgStudyIdInfo': {'id': 'N3769-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combined physical and cognitive exercise intervention', 'description': 'Participants will receive both the physical exercise intervention and the cognitive exercise intervention for 3 months.', 'interventionNames': ['Behavioral: Physical exercise intervention', 'Behavioral: Cognitive exercise intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Physical exercise intervention', 'description': 'Participants will receive the physical exercise intervention for 3 months.', 'interventionNames': ['Behavioral: Physical exercise intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive exercise intervention', 'description': 'Participants will receive the cognitive exercise intervention for 3 months.', 'interventionNames': ['Behavioral: Cognitive exercise intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Participants will receive health education for 3 months.', 'interventionNames': ['Behavioral: Health education']}], 'interventions': [{'name': 'Physical exercise intervention', 'type': 'BEHAVIORAL', 'description': 'Home-based physical exercise with the use of a stationary recumbent style bike.', 'armGroupLabels': ['Combined physical and cognitive exercise intervention', 'Physical exercise intervention']}, {'name': 'Cognitive exercise intervention', 'type': 'BEHAVIORAL', 'description': 'Home-based cognitive exercise with the use of smartphone to complete cognitive activities.', 'armGroupLabels': ['Cognitive exercise intervention', 'Combined physical and cognitive exercise intervention']}, {'name': 'Health education', 'type': 'BEHAVIORAL', 'description': 'Provision of general information about a variety of topics', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02130-4817', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David W Sparrow, DSc', 'role': 'CONTACT', 'email': 'David.Sparrow@va.gov', 'phone': '(857) 364-6400', 'phoneExt': '46400'}, {'name': 'David William Sparrow, DSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'David W Sparrow, DSc', 'role': 'CONTACT', 'email': 'David.Sparrow@va.gov', 'phone': '(857) 364-6400', 'phoneExt': '46400'}], 'overallOfficials': [{'name': 'David William Sparrow, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}