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.
Patients with generalized, segmental or focal dystonias who are being considered for simultaneous bilateral radiofrequency pallidotomy.
Of all ages and gender
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.
Parallel
Radiofrequency Pallidotomy
Procedure/SurgeryRadiofrequency bilateral simultaneous pallidotomy
BFM Dystonia disability scale
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
To study the incidence of new onset or worsening dysphagia or dysarthria in patients with dystonia undergoing bilateral simultaneous pallidotomy
20% improvement in BFM Dystonia disability scale
To compare the proportion of patients having atleast 20% improvement in BFM Dystonia disability scale from baseline to 6 weeks following bilateral simultaneous radiofrequency pallidotomy(early treatment arm) with the proportion of patients with similar improvement from baseline to 6 weeks following acceptance of procedure in those who undergo surgery atleast 12 weeks after accepting the procedure (delayed treatment arm)
20% improvement in BFM Dystonia movement scale
To compare the proportion of patients having atleast 20% improvement in BFM Dystonia movement scale from baseline to 6 weeks following bilateral simultaneous radiofrequency pallidotomy (early treatment arm) with the proportion of patients with similar improvement from baseline to 6 weeks following acceptance of procedure in those who undergo surgery atleast 3 months after accepting the procedure (delayed treatment arm)
Adverse effects
To study the proportion of patients in early and delayed treatment arm who develop adverse effects during the 12 weeks following surgery or agreeing for surgery respectively.
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