NCT01497639

Comparison of the Efficacy of Double Monopolar Versus Interleaving Stimulation Modes for Pallidal Deep Brain Stimulation

Comparison of the Efficacy of Double Monopolar Versus Interleaving Stimulation Modes for the Deep Brain Stimulation Treatment of Primary Generalized or Segmental Dystonia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Pecs · Academic / Other
• Sex: All
• Age: 7 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to compare the efficacy and the safety profile of the newly introduced interleaving stimulation mode to those of the standard double monopolar stimulation mode during pallidal deep brain stimulation of primary generalized or segmental dystonia.

Detailed description

Background: For the treatment of drug-refractory dystonia, bilateral pallidal deep brain stimulation (GPi-DBS) is proven to be an efficient option. On average, 40-55% improvement on dystonia rating scales (DRS) could be achieved according to the results of multicenter trials lasting for years. However, a considerable portion (10-25%) of the patients experience minimal alleviation despite of good electrode placement. These patients can be regarded as non-responders to GPi-DBS defined as having either limited improvement (\< 25% on DRS) or worsening. Besides adjusting the amplitude, frequency or pulse-width of stimulation, one can change the electrode configuration from the commonly applied single monopolar stimulation mode (one contact on the electrode is negative) to either double monopolar stimulation (two -usually adjacent- negative contacts on the electrode are stimulated with same amplitude and pulse-width values) or bipolar stimulation mode (one contact on the electrode is positive) in case of unsatisfactory outcomes. Although these techniques had been utilized in multicenter trials, non-responsiveness to GPi-DBS did occur. Recently the investigators have reported in the Movement Disorders that the newly introduced interleaving stimulation mode was superior to single or double monopolar stimulation in four patients who had initially (6-12 months after implantation) limited response to GPi DBS. Aims of the study: To systematically compare the efficacy and the side-effect profile of double monopolar stimulation mode to those of interleaving stimulation mode in a prospective, randomized, double-blind, and cross-over study. Methods: The investigators would enroll 20-25 patients with drug refractory segmental or generalized primary dystonia undergoing bilateral GPi-DBS implantation within a 2-3 year time frame. The inclusion and exclusion criteria would follow those of the study of Kupsch et al.

Conditions

• Primary Dystonia

Interventions

Type	Name	Description
DEVICE	Interleaving stimulation mode (Medtronic)	Interleaving stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Interleavingr stimulation mode (Medtronic)'
DEVICE	Double monopolar stimulation mode (Medtronic)	Double monopolar stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Double monopolar stimulation mode (Medtronic)'

Timeline

• Start date: 2012-03-01
• Primary completion: 2018-06-07
• Completion: 2018-06-07
• First posted: 2011-12-22
• Last updated: 2018-11-26

Locations

1 site across 1 country: Hungary