Brain pacemaker targets cerebellum to quiet severe tremors
NCT ID NCT07049003
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This study tests whether electrical stimulation of a part of the brain called the deep cerebellar nuclei can safely reduce severe tremor. The participants are adults with essential tremor, cerebellar outflow tremor, or MS-related tremor that has not improved with medication or prior treatments like thalamic deep brain stimulation. The goal is to assess safety and measure changes in tremor severity using a standard rating scale.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Deep Brain Stimulation (Medtronic Percept DBS System)
- What this could lead to
- If successful, this could offer a new treatment option for people with severe tremor who have not benefited from existing therapies.
- What could go wrong
- This is an early-phase safety study with only 12 participants. The approach may not work for everyone, and there are risks associated with brain surgery and device implantation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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- Can a wearable device quiet the shakes of essential tremor?