Efficacy and Safety of Radiofrequency Pallidotomy in the Management of Dystonia
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- Who runs it
- All India Institute of Medical Sciences
- Trial code
- NCT06038097
- Record updated
- 14 September 2023
- Original 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.Read full original descriptionShow less
Efficacy and Safety of Radiofrequency Pallidotomy in the Management of Dystonia - A Delayed Start Randomized Controlled Trial
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.
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.