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

Cervical Dystonia Clinical Trial

Official title:

Prospective,Randomised, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Bilateral Globus Pallidus Internus - in Patients With Medically Refractory Primary Cervical Dystonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148889
• Other study ID #: CD-DBS-2005-JM
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: February 15, 2018
• Start date: July 2005
• Est. completion date: April 2008

Study information

• Verified date: February 2018
• Source: German Parkinson Study Group (GPS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Primary cervical dystonia (CD) affects about 20-40/100.000 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 1:1 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 (verum/placebo) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Intervention

Device:
• Deep brain stimulation (DBS)
Bilateral pallidal stimulation with an implanted DBS device

Locations

Country	Name	City	State
Austria	Medical University Innsbruck, Department of Neurology	Innsbruck	Tyrol
Austria	Department of Neurosurgery, Medical University Vienna	Vienna
Germany	Department of Neurology, Charité, Humboldt-University Berlin	Berlin
Germany	Clinic of Neurosurgery, Medical University Hannover	Hannover
Germany	Department of Neurology, University Heidelberg	Heidelberg
Germany	Department of Neurology, University Kiel	Kiel
Germany	Department for Stereotaxy and Functional Neurosurgery, University Cologne	Köln
Germany	Department of Neurology, University Regensburg	Regensburg
Germany	Department of Neurology, University Rostock	Rostock
Germany	Hertie-Institute for Clinical Brain Research	Tübingen

Sponsors (3)

Lead Sponsor	Collaborator
German Parkinson Study Group (GPS)	Competence Network on Parkinson's Disease, Medtronic

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toronto Western Spasmodic Torticollis Scale (TWSTRS) at 3 months following surgery (comparison between placebo and control group)		3 months
Secondary	side-effects, quality of life, depression, pain, long-term efficacy		5 years

External Links

•   Homepage Competence Network on Parkinson`s disease sponsored by the German government