Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331669
Status:
UNKNOWN
Last Update Posted:
2009-03-04
First Post:
2006-05-26
Brief Title:
Efficacy and Safety of Deep Brain Stimulation DBS of the Pallidal GPi in Patients With Tardive Dystonia
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Multicenter Randomized Trial on the Effects of Pallidal Deep Brain Stimulation for Tardive Dystonia
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
RECRUITING
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 randomized double blind multi-center study is to assess the efficacy and safety of bilateral pallidal deep brain stimulation in patients with tardive dystonia
Detailed Description:
Deep brain stimulation DBS has been established as a new reversible neurosurgical therapeutic option for patients suffering from disabling neurological movement disorders such as essential tremor and Parkinsons disease Recently deep brain stimulation has been successfully applied in patients with primary generalized and segmental dystonia Additionally a number of case reports suggest that pallidal deep brain stimulation may also improve tardive dystonia which may for instance result from the intake of neuroleptics and which is notoriously difficult to treat medically The present study will investigate the effects of pallidal DBS using a double blind randomized design sham- versus verum-stimulation within a 3-months interval post implantation of the electrodes
Initially 60 patients had been calculated in a power analysis to assess significant results based on an average improvement of dystonic symptoms of 30 However in a recent study Damier et al Archives of General Psychiatry 2007 10 out of 10 showed a successful outcome of approximately 50 decrease on the extrapyramidal symptoms rating scale score The exact one- sided lower 95 confidence limit would be 0794 for this result If such an approach is chosen for sample size estimation with 18 verum and 18 placebo patients one would obtain a power of 82 against a placebo effect of 30 success rate For a placebo effect of 25 one needs 1616 patients and for the placebo effect of 20 one needs 1212 patients We thus decided to reduce the sample size to 36- 32- 24 patients It is expected that the continuous primary outcome measure will preserve even higher power than the binary one used in the study mentioned above The local ethical committee has approved this
Initially 60 patients had been calculated in a power analysis to assess significant results based on an average improvement of dystonic symptoms of 30 However in a recent study Damier et al Archives of General Psychiatry 2007 10 out of 10 showed a successful outcome of approximately 50 decrease on the extrapyramidal symptoms rating scale score The exact one- sided lower 95 confidence limit would be 0794 for this result If such an approach is chosen for sample size estimation with 18 verum and 18 placebo patients one would obtain a power of 82 against a placebo effect of 30 success rate For a placebo effect of 25 one needs 1616 patients and for the placebo effect of 20 one needs 1212 patients We thus decided to reduce the sample size to 36- 32- 24 patients It is expected that the continuous primary outcome measure will preserve even higher power than the binary one used in the study mentioned above The local ethical committee has approved this
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