Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT02911103 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Deep Brain Stimulation Surgery for Focal Hand Dystonia

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 157 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fields
  2. Minor Study description expanded, about 8 words
  3. Minor 9 versions Re-verified since Jun 23, 2026, no change to tracked fieldsv147-v155
  4. Minor Study Status, Study Descriptionv146
  5. Minor 17 versions Re-verified since Aug 13, 2025, no change to tracked fieldsv129-v145
Show 21 earlier versionsHide 21 earlier versions
  1. Notable Enrollment target: 3 to 5v128
  2. Minor 12 versions Re-verified since Dec 18, 2024, no change to tracked fieldsv116-v127
  3. Minor Interventions: DBS surgery (Procedure) to DBS surgery (Procedure), Medtronic Activa Rechargeable System (Device)v115
  4. Minor 7 versions Re-verified since Aug 23, 2024, no change to tracked fieldsv108-v114
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02911103
Lead Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Dystonia, Focal Dystonia, Musician's Dystonia
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov