DBS Surgery for Hand Dystonia

Recruiting in Palo Alto (17 mi)

Overseen byDebra J Ehrlich, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

Researchers want to test a procedure called deep brain simulation (DBS) to treat focal hand dystonia (FHD). A device called a neurostimulator is placed in the chest. It is attached to wires placed in brain areas that affect movement. Stimulating these areas can help block nerve signals that cause abnormal movements. Objectives: To test DBS as treatment for FHD. To learn about brain and nerve cell function in people with dystonia. Eligibility: People ages 18 and older with severe FHD who have tried botulinum toxin treatment at least twice Design: Participation lasts 5 years. Participants will be screened with: Medical history Physical exam Videotape of their dystonia Blood, urine, and heart tests Brain MRI scan Chest X-ray Neuropsychological tests: answering questions, doing simple actions, and taking memory and thinking tests. Hand movement tests Participants will have surgery: A frame fixes their head to the operating table. A small hole is made in the skull. Wires are inserted to record brain activity and stimulate the brain while they do simple tasks. The wires are removed and the DBS electrode is inserted into the hole. The neurostimulator is placed under the skin of the chest, with wires running to the electrode in the brain. They will have CT and MRI scans during surgery. Participants will recover in the hospital for about 1 week. The neurostimulator will be turned on 1 4 weeks after discharge. Participants will have regular visits until the study ends. Visits include: Checking symptoms and side effects MRI Movement, thinking, and memory tests If the neurostimulator s battery runs out, participants will have surgery to replace it. ...

Eligibility Criteria

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.

Inclusion Criteria

My condition severely affects my daily activities and work, especially in tasks like writing or playing an instrument.

I have tried botulinum toxin treatments at least twice without enough improvement.

FHD diagnosed by a neurologist

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Exclusion Criteria

I currently have an infection that affects my whole body.

I am on blood thinners that prevent me from having surgery.

My MRI results do not show any issues that would make surgery or the study unsafe for me.

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Treatment Details

Interventions

DBS surgery (Procedure)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ActiveExperimental Treatment2 Interventions

single arm study