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Deep Brain Stimulation for Refractory Tremor

This study is looking at the safety and how well Deep Brain Stimulation (DBS) of the Deep Cerebellar Nuclei works for people with severe tremor that hasn't responded to other treatments. This treatment uses the Medtronic Percept RC Deep Brain Stimulation System. You might be able to join if you have essential tremor (ET), cerebellar tremor, or MS-related tremor and have either tried other treatments like VIM DBS or HIFU thalamotomy without success, or if those treatments weren't suitable for you. The main goal is to track any side effects related to the treatment. The study aims to enroll 12 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 12 participants.
What's involved
Participants will undergo Deep Brain Stimulation (DBS) implant surgery. The study will then monitor for treatment-related adverse events through study completion, which averages 17 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the DBS implant surgery through study completion, which averages 17 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07049003

Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor

Recruiting
PHASE1Ages 21+InterventionalTreatment
The Cleveland Clinic
~12 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Deep Brain Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The incidence and nature of treatment-related adverse events
Measured over From DBS Implant Surgery through study completion, an average of 17 months

Conditions

Tremor
Essential Tremor

Explore related trials

Cerebellar Outflow TremorEssential TremorMultiple Sclerosis

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Jeffrey Negrey, MA
[email protected]
2163166896
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 21 years and older;
Ability to give informed consent;
Diagnosis of ET, cerebellar tremor, or MS-related tremor with a failed a prior intervention (VIM DBS or HIFU thalamotomy) or determined to not be suitable candidates for VIM DBS or HIFU thalamotomy because they have a cerebellar outflow or MS-related tremor.
Tremor history of at least three years;
Tremor that is refractory to medical management;
A score of ≥24 on the Mini Mental State Examination;
Inability to successfully perform ADLs without assistance or has lost interest in social, professional, or personal activities due to tremor

Exclusion

Any other neurological condition that could reduce the safety of study participation including central nervous system vasculitis and intracranial malignancy
A condition that, in the opinion of the clinical investigator, would significantly increase the risk or interfere with study compliance, safety, or outcome;
A diagnosis of dementia;
Tremors due to other neurological conditions such as Parkinson's disease, dystonia, or other conditions not consistent with ET, cerebellar outflow tremor, or MS-related tremor.
Diagnosis of epilepsy;
Major active and untreated psychiatric illness that may interfere with study, such as psychotic disorders or severe personality disorders;
Untreated or inadequately treated depression defined by a score of 20 or greater on the Beck Depression Inventory-II at the time of enrollment;
At risk for suicide defined by a score greater or equal to 3 on the Columbia Suicide Severity Rating Scale (C-SSRS);
Pregnancy;
Unable to communicate with investigators or staff;
Surgical contraindications to DN DBS;
Contraindication to magnetic resonance (MRI) imaging, e.g., weight incompatible with scanner, implanted metallic devices or electrical devices (pacemaker, defibrillator, spinal cord stimulator, prior DBS) or intolerance to MRI contrast agent;
Enrolled in another device, biologic or pharmaceutical study within 30 days of consent in the current study, (i.e., patient cannot be enrolled if participation in another study was not completed at least 30 days prior to consent.);
Evidence of behavior(s) consistent with alcohol or substance abuse/dependence as defined by the criteria outlined in the DSM-V within the preceding six months;
Injection of botulinum toxins into the arm, neck or face within six months prior to baseline;

What this trial measures

  • The incidence and nature of treatment-related adverse eventsFrom DBS Implant Surgery through study completion, an average of 17 months

    The accumulation of adverse events across all subjects