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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To confirm the safety of VOA/VOP thalamic DBS in FHD

Secondary outcome measures

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

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor

1,339 Previous Clinical Trials

649,387 Total Patients Enrolled

58 Trials studying Dystonia

13,483 Patients Enrolled for Dystonia

Debra J Ehrlich, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)

7 Previous Clinical Trials

13,006 Total Patients Enrolled

1 Trials studying Dystonia

85 Patients Enrolled for Dystonia

Media Library

DBS surgery (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02911103 — Phase 1 & 2

Dystonia 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the patient base for this medical experiment?

"Confirmed. According to clinicaltrials.gov, the medical trial initially posted on January 17th 2018 is actively recruiting individuals. As of May 25th 2022, there were 15 participants being sought at a single site."

Answered by AI

Is enrollment for this clinical trial still ongoing?

"Indeed, the information on clinicaltrials.gov highlights that this trial is actively seeking candidates for participation. The research was initially posted on January 17th 2018 and has recently been updated on May 25th 2022. Currently 15 participants are being recruited from a single site."

Answered by AI

Is it possible to participate in this clinical investigation?

"This investigation is enrolling 15 participants between the ages of 22 and 100 with dystonia. To qualify, patients must have a Tubiana/Chamagne score equal to or below 3, lack the capacity to perform at a professional level, or receive a rating of 'severe' on one item in Writer's Cramp Impairment Scale which affects their employment opportunities; additionally they should display significant impairment in quality of life as assessed by SF12 scale. Furthermore those wishing to enrol need to demonstrate failure or inadequate benefit from two botulinum toxin treatments along with an upper extremity BFM subscore higher than 3 or ADDS difficulty"

Answered by AI