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Taking people in United StatesPhase 1

Brain stimulation of the cerebellum for tremor that other treatments did not help

Tests safety of stimulating deep cerebellar nuclei in people with hard-to-treat tremor.

Key facts

Who runs it
The Cleveland Clinic
Where
Cleveland, United StatesSee the site
Trial code
Registry title
Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor
Status
Recruiting
Phase
Phase 1
People taking part
12 people, planned
Started
15 Jan 2026
Expected to end
31 Dec 2029
Type of study
Interventional
Treatments tested
  • Deep Brain Stimulation
Record updated
10 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe tremor that medicines do not control. They test deep brain stimulation of the deep cerebellar nuclei (a brain area that controls movement).

Age
21 years and older
Sex
All sexes
Disease stage
Essential tremor (ET), cerebellar outflow tremor or MS-related tremor for at least three years. The tremor does not respond to medicines. Because of the tremor, people need help with daily activities or have lost interest in social, work or personal activities.
Earlier treatment
People with ET must have had VIM DBS or HIFU thalamotomy that did not work. People with cerebellar outflow or MS-related tremor can join after such a failed treatment, or if they cannot have it. No botulinum toxin injection into the arm, neck or face within six months before the start.
Biomarker or test result
A score of ≥24 on the Mini Mental State Examination (a memory and thinking test).

Main reasons for not taking part

  • Tremor from other conditions such as Parkinson's disease or dystonia
  • Dementia, epilepsy, or another neurological condition such as brain cancer
  • Untreated depression (Beck Depression Inventory-II score of 20 or greater), suicide risk, or major untreated mental illness
  • Cannot have an MRI, for example because of a pacemaker or earlier DBS
  • Pregnancy, or alcohol or drug abuse in the last six months

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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.)
  • Injection of botulinum toxins into the arm, neck or face within six months prior to baseline
  • 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
  • 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

Where in United States

  • Cleveland ClinicCleveland, United StatesContact: Jeffrey Negrey, MATaking people

About the trial

What the trial wants to find out

This objective of this study is to document the safety and feasibility of electrical stimulation of the deep cerebellar nuclei for refractory tremor using the Medtronic Percept RC Deep Brain Stimulation System. The population will consist of patients that have either 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. Those patients with a previous intervention, must have a prior diagnosis of ET, cerebellar outflow tremor, or MS-related tremor. Subjects without a previous intervention must have a diagnosis of cerebellar outflow tremor or MS-related tremor.

The group in the trial

  • Refractory TremorTreatment being tested

    Medtronic Percept RC DBS System

    Treatment: Deep Brain Stimulation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor
Plain-language title
Brain stimulation of the cerebellum for tremor that other treatments did not helpGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
10 July 2026