N/A N=9 Treatment

Deep Brain Stimulation in Patients With Dystonia

Dystonia

Bottom Line

View on ClinicalTrials.gov: NCT00773604 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: The Toronto Western Spasmodic Rating Scale (TWSTRS) Movement Scores Measured Before DBS Surgery (Baseline) and at 12 Months — 33.5 TWSTRS total score change

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Medtronic implantable deep brain stimulation (DBS) system (Device)
Age: Pediatric, Adult, Older Adult · 7+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Feb 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY The Toronto Western Spasmodic Rating Scale (TWSTRS) Movement Scores Measured Before DBS Surgery (Baseline) and at 12 Months	33.5	—

Summary

The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (DBS) of the subthalamic nucleus (STN)for primary dystonia.

Eligibility Criteria

Inclusion Criteria

Refractory primary dystonia diagnosed by a movement disorders neurologist
Severe functional impairment despite optimal medical management, including failed botulinum toxin therapy
Age 7-80 years (UCSF patients) and 18-80 (VA patients)

Exclusion Criteria

Patients considered at high risk for elective neurosurgery because of co-morbid conditions
Brain MRI showing extensive brain atrophy or small vessel ischemic disease
Pregnancy
Inability to tolerate awake microelectrode-guided neurosurgery
Inability to follow up with post-operative study visits
Inability to speak or read English
Patients with a score of 4.5 or lower on the BFMDRS movement scale
Patients with Secondary dystonia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00773604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.