Status:
COMPLETED
Comparison of the Efficacy of Double Monopolar Versus Interleaving Stimulation Modes for Pallidal Deep Brain Stimulation
Lead Sponsor:
University of Pecs
Conditions:
Primary Dystonia
Eligibility:
All Genders
7-75 years
Phase:
NA
Brief 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 ...
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 s...
Eligibility Criteria
Inclusion
- ages of 7 and 75 years
- marked disability owing to primary generalized or segmental dystonia, despite optimal pharmacologic treatment
- disease duration of at least 5 years.
Exclusion
- previous brain surgery;
- cognitive impairment (\< 120 points on the Mattis Dementia Rating Scale)
- moderate-to-severe depression (\> 25 points on the Beck Depression Inventory)
- marked brain atrophy as detected by magnetic resonance imaging
- other medical or psychiatric coexisting disorders that could increase the surgical risk or interfere with completion of the trial
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2018
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01497639
Start Date
March 1 2012
End Date
June 7 2018
Last Update
November 26 2018
Active Locations (1)
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1
Department of Neurology, University of Pécs
Pécs, Baranya, Hungary, H-7623