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NCT06038097
Efficacy and Safety of Radiofrequency Pallidotomy in the Management of Dystonia
NA trial testing Radiofrequency Pallidotomy in Dystonia in 72 participants. Not yet recruiting.
31 December 2026
Quick facts
| Lead sponsor | All India Institute of Medical Sciences |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 1 October 2023 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 March 2027 |
| Sites | 1 location across India |
Drugs / interventions tested
- Radiofrequency Pallidotomy
Conditions studied
- Dystonia — all drugs for Dystonia →
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:
- PubMed search for NCT06038097
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other All India Institute of Medical Sciences trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06038097 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by All India Institute of Medical Sciences
- Last refreshed: 14 September 2023
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