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Efficacy and Safety of Radiofrequency Pallidotomy in the Management of Dystonia
Sponsor: All India Institute of Medical Sciences
Summary
Generalized dystonia is treated with pallidotomy. This is based on observational data which is significantly limited by publication bias and there are no RCTs. The case reports focus on successful outcomes and case series have an inherent selection bias. Bilateral pallidotomy has been used in our institute in a series of patients with generalized and segmental dystonia and have been seen to show good efficacy. However, the existing literature suggests that it is also associated with dysphagia and dysarthria in some cases and thus simultaneous bilateral pallidotomy is not preferred in several centres. However, our center routinely performs simultaneous bilateral pallidotomy. The response rates and compliations of the procedure have not been systematically studied in RCT and we need to generate data on the efficacy and safety of Pallidotomy on generalized and segmental dystonia. This randomized controlled trial will fill the void in knowledge in this field.
Official title: Efficacy and Safety of Radiofrequency Pallidotomy in the Management of Dystonia - A Delayed Start Randomized Controlled Trial
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2023-10-01
Completion Date
2027-03-31
Last Updated
2023-09-14
Healthy Volunteers
No
Conditions
Interventions
Radiofrequency Pallidotomy
Radiofrequency bilateral simultaneous pallidotomy
Locations (1)
All India Institute of Medical Sciences, New Delhi
New Delhi, National Capital Territory of Delhi, India