NCT02911103

Deep Brain Stimulation Surgery for Focal Hand Dystonia

Active, enrolled Phase 1, PHASE2 Last updated 27 March 2026

What this trial tests

Phase 1, PHASE2 trial testing DBS surgery in Dystonia in 5 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 January 2018

Primary endpoint
2 February 2029

2 February 2029

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	17 January 2018
Primary completion	2 February 2029
Estimated completion	2 February 2029
Sites	1 location across United States

Drugs / interventions tested

• DBS surgery
• Medtronic Activa Rechargeable System

Conditions studied

• Dystonia — all drugs for Dystonia →
• Focal Dystonia — all drugs for Focal Dystonia →
• Musician's Dystonia — all drugs for Musician's Dystonia →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

Adults 22 to 100, any sex, with Dystonia or Focal Dystonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment of Dystonia: Medications, Neurotoxins, Neuromodulation, and Rehabilitation.
   Bledsoe IO, Viser AC, San Luciano M. · · 2020 · cited 34× · PMID 33095402 · DOI 10.1007/s13311-020-00944-0
2. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
   Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991