Last reviewed · How we verify

NCT06038097

Efficacy and Safety of Radiofrequency Pallidotomy in the Management of Dystonia

Not yet recruiting NA Last updated 14 September 2023
What this trial tests

NA trial testing Radiofrequency Pallidotomy in Dystonia in 72 participants. Not yet recruiting.

Timeline
1 October 2023
Primary endpoint
31 December 2026
31 March 2027

Quick facts

Lead sponsorAll India Institute of Medical Sciences
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment72
Start date1 October 2023
Primary completion31 December 2026
Estimated completion31 March 2027
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

All India Institute of Medical Sciences

Who can join

Eligibility, any sex, with Dystonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Dystonia

Currently open trials in the same condition.

Other All India Institute of Medical Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06038097.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing