Lesioning Procedures for Movement Disorders
Clinical, Laboratory and Imaging Features, Treatment Trends and Long Term Outcomes of Patients Undergoing Lesioning Procedures for Movement Disorders - A Cohort Study and Registry
1 other identifier
observational
250
1 country
1
Brief Summary
Dystonia is a rare syndrome with varying etiologies. Similarly, tremor conditions refractory to medical management and disabling that they need surgical interventions are rare in our setting. So far there are no randomized controlled trials of pallidotomy for management of dystonia. There is scant literature on the long term efficacy and safety of Pallidotomy, thalamotomy and other such lesioning procedures in the management of movement disorders. The current literature is significantly plagued by publication bias as case reports with successful outcomes are likely to be selectively published in journals or conference abstracts. Lesioning procedures though seem to be effective are often considered to be risky, especially bilateral pallidotomy is not preferred by several centres. However, our center routinely performs simultaneous bilateral pallidotomy. To generate long term data on the efficacy and safety of lesioning procedures in rare diseases like dystonias especially the effect of functional neurosurgery on varying etiologies of the disease, robust registries are required which collect data on all consecutive patients who undergo the procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2023
CompletedFirst Posted
Study publicly available on registry
April 8, 2024
CompletedStudy Start
First participant enrolled
April 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 8, 2024
April 1, 2024
3.7 years
September 12, 2023
April 4, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Long term functional outcomes
Long term outcomes in patients undergoing lesioning procedures for the treatment of Dystonia - Burke Fahn Marsden Dystonia - Disability scale. Lesser score is better
1 year
Long term functional outcomes
Long term outcomes in patients undergoing lesioning procedures for the treatment of Parkinson Disease - Unified Parkinson Disease Rating Scale (UPDRS). Lesser score is better
1 year
Secondary Outcomes (8)
Predictors of outcomes
1 year
Demography
Baseline at enrolment
Clinical features
Baseline at enrolment
Laboratory findings
Baseline at enrolment
Imaging features
Baseline at enrolment
- +3 more secondary outcomes
Study Arms (2)
Lesioning group
Participants who undergo pallidal, subthalamic or thalamic lesioning for the management of Dystonia, Parkinson's disease or essential tremors
Control group
Participants who were considered for pallidal, subthalamic or thalamic lesioning for the management of Dystonia, Parkinson's disease or essential tremors but went on to continue best medical management
Interventions
Radiofrequency, ultrasound guided or other lesioning procedures of the Globus pallidus interna, subthalamic nucleus or Vim nucleus of the thalamus for the management of Movement disorders
Eligibility Criteria
Patients with movement disorders such as Dystonia, Tremors or Parkinson's Disease who are being considered to undergo pallidal, subthalamic or thalamic lesioning procedures.
You may qualify if:
- Patients with movement disorders admitted at the Neurology wards/attending clinics
- Who are being considered for lesioning procedures
- Of all ages and sexes
You may not qualify if:
- · Those who deny consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
All India Institute of Medical Sciences, New Delhi
New Delhi, National Capital Territory of Delhi, 110029, India
Biospecimen
Blood, serum CSF
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 12, 2023
First Posted
April 8, 2024
Study Start
April 15, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
April 8, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- From end of study to five years later
- Access Criteria
- To be provided after approaching through Institute Ethics committee, AIIMS New Delhi