Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02911103 · ClinicalTrials.gov registry record · Phase 1
Deep Brain Stimulation Surgery for Focal Hand Dystonia
A Phase 1 study of Dystonia and Focal Dystonia, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Active
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT02911103 is a Phase 1 study of Dystonia and Focal Dystonia that is active but no longer recruiting, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 5 participants, below the 540-participant average among 28 other Dystonia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02911103, a Phase 1 study of Dystonia and Focal Dystonia, is active but no longer recruiting, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- PROCEDURE DBS surgery
- DEVICE Medtronic Activa Rechargeable System
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-01-17 |
| Est. Completion | 2029-02-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02911103
The ClinicalTrials.gov registry entry for NCT02911103 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 540-participant average among 28 other Dystonia trials with a reported enrollment target (99% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Dystonia appearing as the primary indexed condition, and to 2 interventions - of which DBS surgery is the first listed.
NCT02911103 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02911103 about?
NCT02911103 is a clinical study titled "Deep Brain Stimulation Surgery for Focal Hand Dystonia". 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 ab...
What is the current status of trial NCT02911103?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2018-01-17. Estimated completion is 2029-02-02.
What conditions does trial NCT02911103 study?
This clinical trial studies the following conditions: Dystonia, Focal Dystonia, Musician's Dystonia.
What interventions are being tested in trial NCT02911103?
The interventions under investigation include: DBS surgery (PROCEDURE), Medtronic Activa Rechargeable System (DEVICE).
Who is sponsoring clinical trial NCT02911103?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02911103 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dystonia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Pharmacogenomic Contributions to Trihexyphenidyl Biotransformation and Response in Children With Dystonic Cerebral Palsy
RECRUITING · Phase 1
-
Effects of Exercise on Dystonia Pathophysiology
RECRUITING · NA
-
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
RECRUITING
-
Quantifying Motor Network Dynamics to Predict and Enhance Outcomes in Pediatric Dystonia
RECRUITING · NA
-
Dystonia Genotype-Phenotype Correlation
RECRUITING
-
Sleep-specific DBS Therapy in Parkinson's Disease
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.