Deep cerebellar nucleus stimulation for refractory tremor

Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor

This study will try deep brain stimulation of the deep cerebellar nuclei with the Medtronic Percept RC device to reduce tremor in adults whose essential tremor, cerebellar outflow tremor, or MS-related tremor did not improve with or are not suitable for thalamic DBS or focused ultrasound.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT07049003 on ClinicalTrials.gov

What this trial studies

This Phase 1 study implants the Medtronic Percept RC deep brain stimulation system to target the deep cerebellar nuclei in adults with refractory tremor. Eligible participants have essential tremor, cerebellar outflow tremor, or MS-related tremor and either failed prior VIM DBS or HIFU thalamotomy or are not considered suitable candidates for those procedures. The primary objective is to document safety and feasibility by tracking surgical and device-related adverse events and clinical response after implantation and programming. The single-center trial is conducted at the Cleveland Clinic and will include follow-up visits to monitor tremor severity and functional status.

Who should consider this trial

Good fit: Adults aged 21 and over with a diagnosis of essential tremor, cerebellar outflow tremor, or MS-related tremor that is refractory to medication and who have failed prior VIM DBS or HIFU thalamotomy or are deemed unsuitable for those procedures.

Not a fit: Patients with dementia, other significant central nervous system disorders that increase surgical risk, or tremor from causes outside the listed diagnoses are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could reduce tremor severity and improve daily functioning for patients who have not benefited from or cannot undergo thalamic DBS or focused ultrasound.

How similar studies have performed: Thalamic DBS and HIFU thalamotomy have established benefit for many tremor patients, but stimulation of the deep cerebellar nuclei is a novel, early-stage approach with limited prior clinical data.

Eligibility criteria

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;

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Jeffrey Negrey, MA

Conditions Tremor; Essential Tremor