Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06038097
NA

Efficacy and Safety of Radiofrequency Pallidotomy in the Management of Dystonia

Sponsor: All India Institute of Medical Sciences

View on ClinicalTrials.gov

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

PROCEDURE

Radiofrequency Pallidotomy

Radiofrequency bilateral simultaneous pallidotomy

Locations (1)

All India Institute of Medical Sciences, New Delhi

New Delhi, National Capital Territory of Delhi, India