Deep Brain Stimulation Surgery for Focal Hand Dystonia
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|ClinicalTrials.gov Identifier: NCT02911103|
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : May 24, 2019
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.
To test DBS as treatment for FHD. To learn about brain and nerve cell function in people with dystonia.
People ages 18 and older with severe FHD who have tried botulinum toxin treatment at least twice
Participation lasts 5 years.
Participants will be screened with:
Videotape of their dystonia
Blood, urine, and heart tests
Brain MRI scan
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
Movement, thinking, and memory tests
If the neurostimulator s battery runs out, participants will have surgery to replace it.
|Condition or disease||Intervention/treatment||Phase|
|Dystonia Focal Dystonia Musician's Dystonia||Device: DBS surgery||Phase 1 Phase 2|
To confirm the safety and efficacy of thalamic deep brain stimulation (DBS) targeting the ventralis oralis anterior/ventralis oralis posterior (VOA/VOP) nuclear complex in the treatment of subjects with focal hand dystonia (FHD); and to study the electrophysiologic properties of neurons in the VOA/VOP complex. Deep brain stimulation DBS is FDA approved for Parkinson s disease, Essential tremor, Dystonia (humanitarian exemption), Obsessive- Compulsive disorder (humanitarian exemption) but not for focal hand dystonia.
Five adults with focal hand dystonia will be studied.
This is a pilot study of 5 subjects with severe intractable FHD whose activities of daily living and quality of life are severely impaired. They will be recruited from our clinic and referring practices. The subjects will undergo unilateral VOA/VOP DBS implantation, followed by programming to optimal parameters. The subjects will be followed at monthly intervals for 3 months, then every 3 months for 2 years, and then every 6 months until 5 years from the start. The safety of the procedure will be the primary outcome of the study. Efficacy will be assessed in several secondary outcomes, the most important ones being the change in dystonia severity and a quality of life scores. The electrophysiologic features of the motor ventral thalamic neurons will be recorded intraoperatively.
-Number and severity of adverse events in the 5-year follow-up period.
- Upper extremity sub-score of the Burke-Fahn-Marsden (BFM) scale and Arm Dystonia Disability Scale (ADDS) at baseline and every follow up visit
- For subjects with FHD type musician s dystonia: Tubiana and Chamagne scale at every follow up visit
- For subjects with FHD type Writer s cramp: Writer's Cramp Impairment Scale
- Improvement on patient reported outcomes evaluated by the SF-12 Health Status Survey at baseline and at every follow up visit
- Intraoperatory electrophysiologic characteristics of the motor ventral thalamic neurons
- Neuropsychological evaluation at baseline, 3 and 12 months post DBS surgery
- Dose of botulinum toxin injection required at baseline, 1 and 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Deep Brain Stimulation Surgery for Treatment of Focal Hand Dystonia|
|Study Start Date :||September 21, 2016|
|Estimated Primary Completion Date :||February 2, 2029|
|Estimated Study Completion Date :||February 2, 2029|
Single Arm Study
Device: DBS surgery
Unilateral thalamic DBS therapy
- To confirm the safety of VOA/VOP thalamic DBS in FHD [ Time Frame: 5 years ]Number and severity of adverse events in the 5-year follow-up period.
- Dystonia disability score [ Time Frame: Baseline to 5 years ]Burke-Fahn-Marsden (BFM) scale and Arm Dystonia Disability Scale (ADDS) at baseline and every follow up visit
- FHD severity score [ Time Frame: Baseline to 5 years ]For subjects with FHD type Musician s Dystonia: Tubiana and Chamagne scale at every follow up visit.For subjects with FHD type writer s cramp: Writer s Cramp Impairment Scale
- Health status survey [ Time Frame: Baseline to 5 yrs ]Improvement on patient reported outcomes evaluated by the SF-12 Health Status Survey at baseline and at every follow up visit
- Neuropsychological evaluation [ Time Frame: Baseline, 3 and 12 m ]Neuropsychological evaluation at baseline, 3 and 12 months post DBS surgery
- Dose of botulinum toxin [ Time Frame: 1 and 5 years ]Dose of Botulinum Toxin at 1 and 5 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911103
|Contact: Irene H Dustin, C.R.N.P.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Debra J Ehrlich, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|