Deep Brain Stimulation for Essential Tremor

(rT DBS Trial)

Overseen By Jeffrey Negrey, MA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The Cleveland Clinic

Disqualifiers: Dementia, Epilepsy, Parkinson's, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 17 months

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Deep Brain Stimulation (DBS) for individuals with hard-to-treat tremors. The goal is to determine if electrical pulses deep in the brain can safely and effectively manage tremors unresponsive to other treatments. Individuals who have struggled with tremors for at least three years and find daily tasks challenging due to the tremors might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for tremors that are not controlled by medication, it's possible you may continue your current treatment. Please consult with the trial coordinators for specific guidance.

What prior data suggests that this device is safe for treating refractory tremor?

Studies have shown that deep brain stimulation (DBS) is generally safe for people with movement disorders, such as essential tremor. Research involving over 1,000 patients with Parkinson's disease who received DBS demonstrated improved movement abilities. For essential tremor, other studies with 430 patients reported that most side effects were mild and easily managed.

This suggests that while DBS carries some risks, it is usually well-tolerated. This trial uses the Medtronic Percept RC DBS System, a device already familiar in the medical field, which may reassure participants about its safety. However, this specific trial is in its early stages. As with any treatment, discussing potential risks and benefits with the trial team before participating is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Deep Brain Stimulation (DBS) for Essential Tremor because it offers a unique approach compared to standard treatments like beta-blockers, anti-seizure medications, or focused ultrasound. Unlike these medications, which often work by dampening nerve signals throughout the body, DBS directly targets the brain regions responsible for tremor by delivering electrical impulses. This precise targeting can lead to more effective tremor control with potentially fewer side effects. Additionally, the DBS system used in this trial, the Medtronic Percept RC, features advanced sensing technology that allows for more personalized treatment adjustments.

What evidence suggests that deep brain stimulation might be an effective treatment for essential tremor?

Research shows that deep brain stimulation (DBS), which participants in this trial will receive, can greatly reduce tremor symptoms. For people with essential tremor (ET), studies have found that DBS improves shaking and hand movement, with benefits lasting for years. In one study, patients experienced a 59% reduction in tremor after treatment. Additionally, a multi-center study found that DBS improved symptoms and quality of life for those with ET. This evidence supports the potential effectiveness of DBS for treating tremors that don't respond to other treatments. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with severe tremors that haven't improved after treatments like Vim DBS or HIFU thalamotomy, or those who can't have these treatments due to specific types of tremor related to cerebellar outflow or multiple sclerosis (MS).

Inclusion Criteria

I am 21 years old or older.

Ability to give informed consent

A score of ≥24 on the Mini Mental State Examination

Exclusion Criteria

At risk for suicide defined by a score greater or equal to 3 on the Columbia Suicide Severity Rating Scale (C-SSRS)

I am not a candidate for deep brain stimulation surgery due to health risks.

A condition that, in the opinion of the clinical investigator, would significantly increase the risk or interfere with study compliance, safety, or outcome

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

DBS Implant Surgery

Participants undergo surgery for the implantation of the Medtronic Percept RC Deep Brain Stimulation System

1 week

1 visit (in-person)

Treatment

Participants receive electrical stimulation of the deep cerebellar nuclei for refractory tremor

17 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation

Trial Overview The study tests the safety and effectiveness of Deep Brain Stimulation (DBS) using Medtronic Percept RC System on deep cerebellar nuclei in people whose tremors are difficult to treat.

How Is the Trial Designed?

Group I: Refractory Tremor Experimental Treatment 1 Intervention

Medtronic Percept RC DBS System

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Raynor Cerebellum Project

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8397098/

Deep Brain Stimulation for Tremor: Update on Long-Term ... In PD, tremor is present in up to 79% of the patients and often results in severe social impairment [87]. DBS is shown to be effective in treating this symptom ...

2. neurology.org neurology.org/doi/10.1212/WNL.0000000000204555

Real-world Outcomes from a Prospective, Multicenter Deep ... Results from this ongoing, prospective, multicenter, international outcomes study demonstrate significant improvement in ET related symptoms and quality of ...

3. ohsu.edu ohsu.edu/brain-institute/dbs-outcomes

DBS Outcomes | Brain Institute Less tremor, improved hand function: A 2003 study found that DBS significantly improved tremor and hand function. Benefits were present six or seven years after ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0022510X22000521

Deep brain stimulation for the treatment of tremor The earlier Vim DBS cohort reported 32% reduction of tremor, compared to 59% reduction in the more recently treated cZI DBS group. Patient ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23018417/

Long-term effects of deep brain stimulation for essential ... Results: Twenty-six patients responded, with a median follow-up of 41 months. Approximately half of the patients had more than 48 months of follow-up. At the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02649166

Responsive Deep Brain Stimulator for Essential Tremor The overall objective of this early feasibility study is to provide preliminary data on the safety and efficacy of "closed-loop" deep brain ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20623768/

Deep brain stimulation for essential tremor: a systematic ... A total of 430 patients who had received DBS for essential tremor were identified. Most of the reported adverse events were mild and could be treated through ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1353802025006790

Prevalence and incidence of Deep Brain Stimulation ... First, analyses of data from the National Inpatient Sample revealed that 2.1 % of ET patients underwent DBS from 1993 to 2017 [7]. A second study documented ...