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Procedure

DBS Surgery for Hand Dystonia

Phase 1 & 2
Waitlist Available
Led By Debra J Ehrlich, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients must have failed or achieved inadequate benefit with at least two trials of botulinum toxin treatments
BFM upper extremity subscore of 3 or more or ADDS difficulty of performing score equal to or more than 3
Must not have
Subjects with an active systematic infection
Subjects who are on anticoagulation therapy that would preclude their ability to undergo the implant procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new procedure to treat focal hand dystonia, a condition that causes involuntary muscle movements. A device is placed in the chest and attached to wires in the brain, which stimulating the areas affected by dystonia can help to block nerve signals and improve symptoms.

Who is the study for?
Adults over 18 with severe focal hand dystonia (FHD) who haven't improved after two botulinum toxin treatments. They must not have widespread neurological issues, prior brain surgery, or be pregnant/nursing. Participants need to agree to use contraception and should not have metal in their body that's unsafe for MRI scans.
What is being tested?
The trial is testing deep brain stimulation (DBS) surgery for FHD treatment. A neurostimulator device will be implanted in the chest and connected to electrodes in the brain, aiming to block signals causing abnormal movements. The study spans five years with regular follow-ups.
What are the potential side effects?
Potential side effects include discomfort from the implant, infection risk at surgical sites, possible changes in mood or thinking patterns due to brain stimulation, headache or pain related to surgery recovery, and equipment malfunction requiring additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tried botulinum toxin treatments at least twice without enough improvement.
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I have difficulty using my arms for daily tasks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have an infection that affects my whole body.
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I am on blood thinners that prevent me from having surgery.
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My condition involves widespread neurological issues, including dystonia.
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My MRI results do not show any issues that would make surgery or the study unsafe for me.
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I have had brain surgery before.
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I cannot lay flat on my back for an hour.
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I cannot appoint someone to make decisions for me if I'm unable.
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I am younger than 22 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To confirm the safety of VOA/VOP thalamic DBS in FHD
Secondary study objectives
Neuropsychological Evaluation
To determine if thalamic DBS targeting the VOA/VOP nuclear complex results in clinical improvement of severe intractable FHD
To determine if thalamic DBS targeting the VOA/VOP nuclear complex results in improved patient reported outcomes
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention
single arm study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DBS surgery
2011
N/A
~70

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,377 Previous Clinical Trials
651,834 Total Patients Enrolled
1 Trials studying Focal Dystonias
40 Patients Enrolled for Focal Dystonias
Debra J Ehrlich, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
7 Previous Clinical Trials
12,719 Total Patients Enrolled

Media Library

DBS surgery (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02911103 — Phase 1 & 2
Focal Dystonias Research Study Groups: Active
Focal Dystonias Clinical Trial 2023: DBS surgery Highlights & Side Effects. Trial Name: NCT02911103 — Phase 1 & 2
DBS surgery (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02911103 — Phase 1 & 2
~1 spots leftby Feb 2029
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