Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272246
Status:
UNKNOWN
Last Update Posted:
2006-01-05
First Post:
2006-01-04
Brief Title:
Bilateral Internal Pallidum Stimulation in Primary Generalized Dystonia
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2006-01
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:
Primary generalized dystonia also called idiopathic torsion dystonia or dystonia musculorum deformans is a disabling neurological condition which usually starts in childhood mostly in a lower limb and spreads to other body parts as the disease progresses Medical treatment is usually ineffective and most patients become wheelchair bound or even bedridden Recently several case series and one RCT reported favourable results of bilateral deep brain stimulation DBS of the globus pallidus internus GPi for primary generalized dystonias However the number of patients treated with bilateral GPi stimulation is still limited Therefore we propose a RCT to investigate whether bilateral DBS of the GPi is an effective and safe treatment in patients with primary generalized dystonia
Detailed Description:
Study design and methods
This is a randomised double-blind placebo-controlled multicentre study comparing the effect of bilateral DBS of the GPi with placebo in patients with invalidating primary generalized dystonia After inclusion in the study see inexclusioncriteria a preoperative formal baseline assessment is performed Within six weeks after the inclusion the patients undergo the stereotactic implantation of the stimulation equipment in the GPi Immediately after surgery the patients are randomly allocated to direct stimulation treatment group or delayed stimulation control group in which the stimulator will se switched on 0 Volt before discharge from the hospital by an independent neurologist or neurosurgeon The patients in both groups are able to control whether the stimulation is active 0 Volt or not In this way the patients and the assessors are blinded In each centre the postoperative care of the patients will take place according to a stratified stimulation parameter protocol which assures comparable information in both groups Six months postoperatively the first formal outcome assessment is performed by the same blinded assessor After completion of this assessment the stimulators in the control group are activated by an independent neurologist or neurosurgeon From this moment all 24 patients have active DBS However the patients and blinded assessor remain unaware of the result of the randomisation All patients are followed for another six months after which the second outcome assessment is made by the same assessor Four Dutch centres experienced in DBS have agreed to participate in the study It is estimated that each centre will include at least 4 patients Because these centra are geographically spread over the country patients can be operated and controlled nearby
This is a randomised double-blind placebo-controlled multicentre study comparing the effect of bilateral DBS of the GPi with placebo in patients with invalidating primary generalized dystonia After inclusion in the study see inexclusioncriteria a preoperative formal baseline assessment is performed Within six weeks after the inclusion the patients undergo the stereotactic implantation of the stimulation equipment in the GPi Immediately after surgery the patients are randomly allocated to direct stimulation treatment group or delayed stimulation control group in which the stimulator will se switched on 0 Volt before discharge from the hospital by an independent neurologist or neurosurgeon The patients in both groups are able to control whether the stimulation is active 0 Volt or not In this way the patients and the assessors are blinded In each centre the postoperative care of the patients will take place according to a stratified stimulation parameter protocol which assures comparable information in both groups Six months postoperatively the first formal outcome assessment is performed by the same blinded assessor After completion of this assessment the stimulators in the control group are activated by an independent neurologist or neurosurgeon From this moment all 24 patients have active DBS However the patients and blinded assessor remain unaware of the result of the randomisation All patients are followed for another six months after which the second outcome assessment is made by the same assessor Four Dutch centres experienced in DBS have agreed to participate in the study It is estimated that each centre will include at least 4 patients Because these centra are geographically spread over the country patients can be operated and controlled nearby
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