CompletedPhase 3

Double-blind, Multicenter Study to Assess the Efficacy of Bilateral Pallidal Stimulation in Patients With Medically Refractory Primary Cervical Dystonia

Austria, Germany63 participantsStarted 2005-07

Plain-language summary

The purpose of this study is to investigate the efficacy and safety of bilateral pallidal stimulation in patients with medically refractory primary cervical dystonia.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Primary cervical dystonia * Disease duration 3 years or longer * Adult patient (18 years or older) * TWSTRS severity score 15 or more * Non-response to Botulinum Toxin * Non-response to oral antidystonic medication * Informed consent Exclusion Criteria: * Dementia (Mattis Dementia Rating Scale below 120) * Severe depression (Beck Depression Inventory \>25) * Previous functional stereotactic surgery * Hemidystonia or generalized dystonia * Severe brain atrophy * Contraindication against surgery

What they're measuring

Toronto Western Spasmodic Torticollis Scale (TWSTRS) at 3 months following surgery (comparison between placebo and control group)

Timeframe: 3 months

Trial details

NCT IDNCT00148889

SponsorGerman Parkinson Study Group (GPS)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-04

View on ClinicalTrials.gov More Cervical Dystonia trials