Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148889
Status:
COMPLETED
Last Update Posted:
2018-02-19
First Post:
2005-09-07
Brief Title:
Double-blind Multicenter Study to Assess the Efficacy of Bilateral Pallidal Stimulation in Patients With Medically Refractory Primary Cervical Dystonia
Sponsor:
German Parkinson Study Group GPS
Organization:
German Parkinson Study Group GPS
Study Overview
Official Title:
ProspectiveRandomised Double-blind Multicenter Study to Assess the Efficacy and Safety of Bilateral Globus Pallidus Internus - in Patients With Medically Refractory Primary Cervical Dystonia
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Primary cervical dystonia CD affects about 20-40100000 population The disease is chronic and life-long The therapy of choice are local intramuscular Botulinum Toxin injections given every three months Oral medication such as anticholinergics or dopamine depleting drugs are usually of limited efficacy or their use is limited by intolerable side-effects About 5-10 of CD patients develop neutralizing antibodies against Botulinum Toxin Two previous controlled multicenter trials have shown the efficacy and safety of bilateral pallidal stimulation in patients with primary segmental and generalized dystonia one study was performed by our group
Following surgery patients will be randomized 11 to verum or placebo stimulation for a period of three months Primary outcome measure is the TWSTRS Toronto Western Spasmodic Torticollis Rating Scale - a validated and widely accepted physician-based outcome measure for cervical dystonia The independent TWSTRS raters are movement disorders specialists unaware of the stimulation status verumplacebo and they compare the TWSTRS-score at baseline and 3-months follow-up Our hypothesis is that stimulated patients will have a significantly better improvement of dystonia as compared to those without stimulation placebo group
After the 3-months period all patients are unblinded and receive continuous effective stimulation by the implanted system Regular follow-up visits are scheduled every 12 months for 5 years postoperatively to assess the long-term efficacy of pallidal stimulation Side-effects are assessed in a standardized way and include the assessment of surgery-induced as well as stimulation-induced side-effects
Following surgery patients will be randomized 11 to verum or placebo stimulation for a period of three months Primary outcome measure is the TWSTRS Toronto Western Spasmodic Torticollis Rating Scale - a validated and widely accepted physician-based outcome measure for cervical dystonia The independent TWSTRS raters are movement disorders specialists unaware of the stimulation status verumplacebo and they compare the TWSTRS-score at baseline and 3-months follow-up Our hypothesis is that stimulated patients will have a significantly better improvement of dystonia as compared to those without stimulation placebo group
After the 3-months period all patients are unblinded and receive continuous effective stimulation by the implanted system Regular follow-up visits are scheduled every 12 months for 5 years postoperatively to assess the long-term efficacy of pallidal stimulation Side-effects are assessed in a standardized way and include the assessment of surgery-induced as well as stimulation-induced side-effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None