Lesioning Procedures for Movement Disorders

Sponsor
All India Institute of Medical Sciences
Study ID
NCT06352268
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pallidal, subthalamic or thalamic lesioning — PROCEDURE
    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 Details

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.

Key Dates

First listed
Apr 8, 2024
Start date
Apr 15, 2024
Status verified
Apr 2024
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Lesioning group
    Participants who undergo pallidal, subthalamic or thalamic lesioning for the management of Dystonia, Parkinson's disease or essential tremors
  • Arm: 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

Primary Outcome Measure

Long term functional outcomes [ Time Frame: 1 year ]

Central Contacts

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