Actively Recruiting
Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor
Led by The Cleveland Clinic · Updated on 2025-07-03
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
R
Raynor Cerebellum Project
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of electrical stimulation targeting the deep cerebellar nuclei to treat refractory tremor. The study focuses on patients who have either not responded to previous interventions like Vim DBS or HIFU thalamotomy or are not suitable candidates for these treatments due to cerebellar outflow or multiple sclerosis-related tremors. Participants must have a diagnosis of essential tremor, cerebellar outflow tremor, or MS-related tremor, with some having prior treatment history and others not. The intervention involves using the Medtronic Percept RC Deep Brain Stimulation System to deliver deep brain stimulation to the deep cerebellar nuclei. This is a Phase 1 study evaluating this device-based treatment. Patients will receive the DBS implant surgery and then be monitored over an average of 17 months. The study tracks treatment-related adverse events, tremor severity using rating scales, and brain activity related to tremor oscillations. Participants will be involved from the time of DBS implant surgery through study completion, approximately 17 months. Assessments include monitoring for adverse events, using the Fahn Tolosa Marin Tremor Rating Scale to measure tremor changes, recording DBS-evoked potentials, and analyzing tremor-related brain oscillations. The research team will regularly evaluate safety and tremor outcomes during this period to understand the treatment's effects and feasibility.
CONDITIONS
Brief Title
Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years and older
- Ability to give informed consent
- Diagnosis of essential tremor, cerebellar tremor, or MS-related tremor with failed prior intervention (Vim DBS or HIFU thalamotomy) or not suitable for these treatments
- Tremor history of at least three years
- Tremor resistant to medical management
- Mini Mental State Examination score of 24 or higher
- Unable to perform activities of daily living without assistance or loss of interest in social, professional, or personal activities due to tremor
You will not qualify if you...
- Any other neurological condition that could reduce safety, including CNS vasculitis or intracranial malignancy
- Conditions increasing risk or interfering with study compliance or safety
- Diagnosis of dementia
- Tremors caused by Parkinson's disease, dystonia, or other non-eligible neurological conditions
- Diagnosis of epilepsy
- Major untreated psychiatric illness such as psychotic or severe personality disorders
- Untreated or inadequately treated depression (Beck Depression Inventory-II score 20 or greater)
- Suicide risk (Columbia Suicide Severity Rating Scale score 3 or greater)
- Pregnancy
- Unable to communicate with study staff
- Surgical contraindications to deep cerebellar nuclei DBS
- Contraindications to MRI, including weight limits, implanted metallic or electrical devices, or intolerance to contrast agents
- Enrollment in another device, biologic, or pharmaceutical study within 30 days prior to consent
- Recent alcohol or substance abuse behavior within six months
- Botulinum toxin injections in arm, neck, or face within six months prior to baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo implantation of the Deep Brain Stimulation device targeting the deep cerebellar nuclei.
1 surgical visit and approximately 6 post-operative visits
Duration - Up to an average of 17 months
Participants are monitored for treatment-related effects and device performance following implantation.
Regular follow-up visits over the monitoring period
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
J
Jeffrey Negrey, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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