Efficacy and Safety of Radiofrequency Pallidotomy in the Management of Dystonia

Condition(s) studied

Investigational drug(s) / intervention(s)

Radiofrequency Pallidotomy: Radiofrequency bilateral simultaneous pallidotomy

Study 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.

Eligibility

Primary outcome measure(s)

• BFM Dystonia disability scale — 6 weeks
  To compare the BFM Dystonia disability scale 6 weeks following bilateral simultaneous radiofrequency pallidotomy (early treatment arm) with the BFM Dystonia disability scale 6 weeks following acceptance of the procedure in those who were randomized to undergo the procedure atleast 12 weeks after accepting the the procedure (delayed treatment arm)
• Adverse effects: New onset or worsening Dysphagia or dysarthria — 12 weeks
  To study the incidence of new onset or worsening dysphagia or dysarthria in patients with dystonia undergoing bilateral simultaneous pallidotomy

Trial sites (1)

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