DBS Surgery for Hand Dystonia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a procedure called deep brain stimulation (DBS) to assist individuals with severe focal hand dystonia, a condition causing involuntary hand movements. The treatment places a device in the chest connected to wires in the brain to block the nerve signals causing these movements. Researchers aim to gain insights into brain and nerve cell function in those with dystonia. Individuals with severe hand dystonia who have tried botulinum toxin treatment at least twice may be suitable candidates for this trial. As a Phase 1 and Phase 2 trial, the study focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulation therapy (blood thinners), you may not be able to participate in the trial.
What prior data suggests that this procedure is safe for treating focal hand dystonia?
Research has shown that deep brain stimulation (DBS) is generally safe for treating dystonia, a movement disorder. Studies have found that DBS can improve symptoms and enhance the quality of life for people with various types of dystonia. These studies also report that DBS is well-tolerated and has maintained a good safety record over many years.
Although some negative side effects can occur, they are usually mild or manageable. These may include temporary issues at the surgery site or the need to adjust the stimulation settings. Overall, DBS is considered a safe option for those dealing with movement disorders like dystonia.12345Why are researchers excited about this trial?
Deep Brain Stimulation (DBS) surgery is unique because it offers a targeted approach to treating hand dystonia, a condition often managed with medications like botulinum toxin injections or oral drugs that can have systemic effects. Unlike these treatments, DBS involves implanting electrodes in specific areas of the brain to modulate abnormal nerve signals, which could provide more precise symptom control with potentially fewer side effects. Researchers are excited about DBS because it has shown promise in other movement disorders, like Parkinson's disease, suggesting it might offer significant relief for hand dystonia patients who have not responded well to conventional therapies.
What evidence suggests that DBS surgery is effective for focal hand dystonia?
Research has shown that deep brain stimulation (DBS) effectively treats various types of dystonia, including focal hand dystonia (FHD). One study found that DBS improved movement and quality of life for people with dystonia. Another analysis confirmed that DBS is safe and significantly reduces symptoms. This procedure involves placing a small device in the chest, connected to wires in the brain, to help block abnormal nerve signals. Early findings suggest that DBS can lessen the severity of involuntary movements in people with FHD. Participants in this trial will undergo DBS surgery to evaluate its effectiveness specifically for hand dystonia.12678
Who Is on the Research Team?
Debra J Ehrlich, M.D.
Principal Investigator
National Institute of Neurological Disorders and Stroke (NINDS)
Are You a Good Fit for This Trial?
Adults over 18 with severe focal hand dystonia (FHD) who haven't improved after two botulinum toxin treatments. They must not have widespread neurological issues, prior brain surgery, or be pregnant/nursing. Participants need to agree to use contraception and should not have metal in their body that's unsafe for MRI scans.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Recovery
Participants undergo DBS surgery and recover in the hospital for about 1 week
Post-Surgery Adjustment
The neurostimulator is turned on 1-4 weeks after discharge, and participants have regular visits for symptom and side effect checks, MRI, and movement, thinking, and memory tests
Follow-up
Participants are monitored for safety and effectiveness with regular follow-up visits every month for 3 months, then every 3 months for 2 years, and every 6 months until 5 years
What Are the Treatments Tested in This Trial?
Interventions
- DBS surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Neurological Disorders and Stroke (NINDS)
Lead Sponsor