Status:
NOT_YET_RECRUITING
Efficacy and Safety of Radiofrequency Pallidotomy in the Management of Dystonia
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Dystonia
Eligibility:
All Genders
Phase:
NA
Brief 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 out...
Detailed Description
Deep brain stimulation surgery (DBS) has become the standard of care for the management of generalized dystonia It has been shown in Randomized controlled trials to be effective and safe.1-3 Since the...
Eligibility Criteria
Inclusion
- Patients with generalized, segmental or focal dystonias who are being considered for simultaneous bilateral radiofrequency pallidotomy.
- Of all ages and gender
Exclusion
- Those who deny consent
- Pregnant ladies and women of childbearing potential without adequate contraception
- Those who have undergone botulinum toxin injection in the last 12 weeks or those who are being planned for the same in the upcoming 12 weeks.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06038097
Start Date
October 1 2023
End Date
March 31 2027
Last Update
September 14 2023
Active Locations (1)
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1
All India Institute of Medical Sciences, New Delhi
New Delhi, National Capital Territory of Delhi, India, 110029