Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-20 @ 11:31 AM
Study NCT ID:
NCT02982304
Status:
UNKNOWN
Last Update Posted:
2020-11-02
First Post:
2016-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004421', 'term': 'Dystonia'}, {'id': 'D020821', 'term': 'Dystonic Disorders'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2016-11-14', 'studyFirstSubmitQcDate': '2016-11-30', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Burke Fahn Marsden Disability Rating Scale (BFMDRS)', 'timeFrame': '3 months'}, {'measure': 'SF-36 Quality of Life Scale', 'timeFrame': '3 months'}, {'measure': 'Adverse effects of Vim or Vim + GPi Neuromodulation', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dystonia', 'Dystonia, Secondary']}, 'referencesModule': {'references': [{'pmid': '26241157', 'type': 'BACKGROUND', 'citation': 'Slotty PJ, Poologaindran A, Honey CR. A prospective, randomized, blinded assessment of multitarget thalamic and pallidal deep brain stimulation in a case of hemidystonia. Clin Neurol Neurosurg. 2015 Nov;138:16-9. doi: 10.1016/j.clineuro.2015.07.012. Epub 2015 Jul 29.'}, {'pmid': '24333801', 'type': 'BACKGROUND', 'citation': 'Prudente CN, Hess EJ, Jinnah HA. Dystonia as a network disorder: what is the role of the cerebellum? Neuroscience. 2014 Feb 28;260:23-35. doi: 10.1016/j.neuroscience.2013.11.062. Epub 2013 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'Dystonia is increasingly being considered as a multi-nodal network disorder involving both basal ganglia and cerebellar dysfunction. The aim of this study is to determine if "Multi-Target" Thalamic and Pallidal Deep Brain Stimulation improves hemi-dystonia patients who are receiving inadequate therapy from GPi DBS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosed with hemi-dystonia secondary to stroke\n2. Candidate for GPi DBS\n3. Able to provide informed consent\n\nExclusion Criteria:\n\n1. History of intracranial pathology (such as multiple sclerosis, tumors, or aneurysms) that may account for dystonia or essential tremor.\n2. History or evidence of ongoing psychiatric or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease).\n3. Incompetent adults or those unable to communicate."}, 'identificationModule': {'nctId': 'NCT02982304', 'briefTitle': 'Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia', 'orgStudyIdInfo': {'id': 'H14-03185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pallidal (GPi) Deep Brain Stimulation', 'description': 'GPi is the standard target for treating most dystonia. This setting will be the active comparator', 'interventionNames': ['Device: Deep Brain Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Thalamic (Vim) Deep Brain Stimulation', 'description': 'Vim is the standard target to treat cerebellar dysfunction in movement disorders. It is not routinely used in secondary dystonia', 'interventionNames': ['Device: Deep Brain Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'GPi + Vim (Multi-Target) Deep Brain Stimulation', 'description': 'Combined stimulation of GPi and Vim stimulation (both electrodes ON)', 'interventionNames': ['Device: Deep Brain Stimulation']}], 'interventions': [{'name': 'Deep Brain Stimulation', 'type': 'DEVICE', 'description': 'Deep Brain Stimulation Electrode', 'armGroupLabels': ['GPi + Vim (Multi-Target) Deep Brain Stimulation', 'Pallidal (GPi) Deep Brain Stimulation', 'Thalamic (Vim) Deep Brain Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Christopher R Honey, MD, DPhil', 'role': 'CONTACT', 'email': 'chris.honey@telus.net', 'phone': '604.875.5894'}], 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Chris Honey, MD,DPhil,FRCSC', 'role': 'CONTACT', 'email': 'chris.honey@telus.net', 'phone': '604-875-5894'}, {'name': 'Leah Polyhronopoulos, BSc', 'role': 'CONTACT', 'email': 'leahpoly@mail.ubc.ca', 'phone': '778-938-6127'}], 'overallOfficials': [{'name': 'Chris Honey, MD,DPhil,FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christopher Honey', 'investigatorAffiliation': 'University of British Columbia'}}}}