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Starting soon Observational

Lesioning Procedures for Movement Disorders

NCT06352268 · tracked via the Priya Life Science India tracker
Phase
Observational
Started
2024-04-15
Last updated
2024-04-08

Condition(s) studied

DystoniaParkinson DiseaseEssential Tremor

Investigational drug(s) / intervention(s)

Pallidal, subthalamic or thalamic lesioning

Pallidal, subthalamic or thalamic lesioning: 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

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with movement disorders admitted at the Neurology wards/attending clinics * Who are being considered for lesioning procedures * Of all ages and sexes Exclusion Criteria: · Those who deny consent

Primary outcome measure(s)

  • Long term functional outcomes — 1 year
    Long term outcomes in patients undergoing lesioning procedures for the treatment of Dystonia - Burke Fahn Marsden Dystonia - Disability scale. Lesser score is better
  • Long term functional outcomes — 1 year
    Long term outcomes in patients undergoing lesioning procedures for the treatment of Parkinson Disease - Unified Parkinson Disease Rating Scale (UPDRS). Lesser score is better

Trial sites (1)

FacilityCityRegionStatus
All India Institute of Medical Sciences, New Delhi New Delhi National Capital Territory of Delhi
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06352268 on ClinicalTrials.gov ↗ ← All trials in India