DBS Surgery for Hand Dystonia

Overseen By Debra J Ehrlich, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Must not be taking: Anticoagulants, Psychotropics

Disqualifiers: Pregnancy, Prior brain surgery, Dementia, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

5 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment DBS surgery for hand dystonia?

Deep brain stimulation (DBS) has shown to be effective in treating various types of dystonia, including primary genetic generalized dystonia and segmental dystonia, with improvements up to 90% in some cases. It is particularly beneficial for patients with primary dystonia, and the globus pallidus internus is often the preferred target for this treatment. ^{1 2 3 4 5}

Is DBS surgery generally safe for humans?

DBS surgery has some risks, including complications related to the surgery itself and the hardware used, such as lead fractures or migration, especially in dystonia patients. While most complications are not severe or permanent, they can occur, and it's important to discuss these potential risks with your doctor. ^{6 7 8 9 10}

How is DBS surgery different from other treatments for hand dystonia?

DBS surgery for hand dystonia is unique because it involves implanting electrodes in the brain to deliver electrical impulses, which can be adjusted and reversed, unlike permanent surgical procedures. This treatment is particularly beneficial for patients with primary genetic dystonia and offers a customizable approach compared to traditional medication or lesion-based surgeries. ^{1 2 4 11 12}

What is the purpose of this trial?

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.

Research Team

Debra J Ehrlich, M.D.

Principal Investigator

National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria

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

My condition severely affects my daily activities and work, especially in tasks like writing or playing an instrument.

I have tried botulinum toxin treatments at least twice without enough improvement.

FHD diagnosed by a neurologist

Exclusion Criteria

I currently have an infection that affects my whole body.

I am on blood thinners that prevent me from having surgery.

My MRI results do not show any issues that would make surgery or the study unsafe for me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery and Initial Recovery

Participants undergo DBS surgery and recover in the hospital for about 1 week

1 week

Inpatient stay

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

4 weeks

Regular visits

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

5 years

Monthly, then quarterly, then biannual visits

Treatment Details

Interventions

• DBS surgery

Trial Overview The trial is testing deep brain stimulation (DBS) surgery for FHD treatment. A neurostimulator device will be implanted in the chest and connected to electrodes in the brain, aiming to block signals causing abnormal movements. The study spans five years with regular follow-ups.

Participant Groups

Group I: Active Experimental Treatment 2 Interventions

single arm study

Who Is Running the Clinical Trial?

National Institute of Neurological Disorders and Stroke (NINDS)

Lead Sponsor

Trials

1,403

Recruited

655,000+

Findings from Research

Deep brain stimulation (DBS) for Parkinson's disease is generally safe, with a low mortality rate of 0.2% and permanent morbidity at 0.6%, but complications such as intracerebral hemorrhage (ICH) and seizures can occur in a small percentage of cases.

The study found that the type of lead used in DBS can influence complications, with Medtronic's leads associated with higher rates of perielectrode brain edema compared to Boston Scientific's, highlighting the need for further research on hardware design to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. Servello, D., Galbiati, TF., Iess, G., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Deep brain stimulation in dystonia. [2005]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for dystonia in adults. Overview and developments. [2017]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for dystonia. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation in dystonia: current aspects of deep brain stimulation. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Factors predicting protracted improvement after pallidal DBS for primary dystonia: the role of age and disease duration. [2021]

6. Scotland pubmed.ncbi.nlm.nih.gov

Painful cervical dystonia triggered by the extension wire of a deep brain stimulator. [2012]

7. Austria pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation surgery. [2017]

9. Scotland pubmed.ncbi.nlm.nih.gov

Increased risk of lead fracture and migration in dystonia compared with other movement disorders following deep brain stimulation. [2004]

10. England pubmed.ncbi.nlm.nih.gov

Operative and hardware complications of deep brain stimulation for movement disorders. [2016]

11. England pubmed.ncbi.nlm.nih.gov

Dystonia: a surgeon's perspective. [2010]

12. United States pubmed.ncbi.nlm.nih.gov

Sustained relief of generalized dystonia despite prolonged interruption of deep brain stimulation. [2013]