Deep Brain Stimulation Surgery for Focal Hand Dystonia

Summary

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.

...

Conditions

• Dystonia
• Focal Dystonia
• Musician's Dystonia

Interventions

PROCEDURE

DBS surgery

Unilateral thalamic DBS therapy

DEVICE

Medtronic Activa Rechargeable System

Used for diagnostic purposes.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  lead NIH

Principal Investigators

• Debra J Ehrlich, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

22 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-17

Primary Completion

2029-02-02

Completion

2029-02-02

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations