Deep Brain Stimulation for Essential Tremor

Recruiting at 1 trial location

Overseen By Mark Amandola

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Neurological disorder, Dementia, Psychiatric illness, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During DBS placement surgery

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how deep brain stimulation, a treatment using electrical impulses, affects brain connections in people with essential tremor. Essential tremor causes uncontrollable shaking, often in the hands, not linked to another disease. The goal is to understand how the treatment alters brain activity and helps manage tremors. Suitable participants have tried several medications without success and find their tremor severely impacts daily life. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for essential tremor.

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 people whose tremor is not helped by medications or who have intolerable side effects, it's possible you may continue your current treatment.

What prior data suggests that Deep Brain Stimulation is safe for essential tremor?

Research has shown that Deep Brain Stimulation (DBS) for essential tremor is generally safe, though some side effects may occur. In a study of 430 patients, most side effects were mild and manageable. Common issues included changes in speech, tingling sensations, temporary weakness, and headaches. Specifically, 11% of patients experienced speech changes, 6% felt tingling, another 6% had temporary weakness, and 7% reported headaches.

Additionally, DBS significantly improved essential tremor symptoms and quality of life for up to one year after treatment. This indicates that while some risks exist, the benefits may outweigh them for many individuals. Discussing treatment options with a healthcare provider remains crucial for making an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Deep Brain Stimulation (DBS) is unique for treating Essential Tremor because it directly targets specific brain areas responsible for tremors, which current options like medications and physical therapy can't do. Unlike drugs that may take time to show effects and often come with side effects, DBS can offer immediate and significant relief by delivering electrical impulses to the brain. Researchers are excited about DBS because it opens up a new way to manage symptoms, especially for patients who haven't found success with traditional treatments.

What evidence suggests that Deep Brain Stimulation is effective for Essential Tremor?

Research has shown that Deep Brain Stimulation (DBS), the treatment under study in this trial, can greatly help people with essential tremor. Several studies have found that DBS noticeably reduces shaking in the arms, head, and voice. One study noted that these improvements lasted up to seven years after the procedure. Another analysis found that symptoms improved by up to 60% with DBS. These findings suggest that DBS can effectively manage essential tremor. ^{1 3 5 6 7}

Who Is on the Research Team?

Albert J Fenoy, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for individuals with Essential Tremor that's not caused by another disease or injury, who haven't found relief through medications, or can't tolerate medication side effects. Their tremors must significantly affect their life quality and be confirmed by a specialist. People with severe psychiatric issues, cognitive impairments, metal in their body, recent substance abuse, pregnancy, prior brain surgery in the target area, significant neurological disorders other than ET or major medical conditions affecting the brain are excluded.

Inclusion Criteria

My tremor doesn't improve with medications or the side effects are too severe.

I have been diagnosed with Essential Tremor by a specialist, not caused by another condition or injury.

My tremor severely affects my daily life.

Exclusion Criteria

I have had surgery to target a specific area of my brain.

I cannot have surgery for deep brain stimulation.

I have a severe mental health condition with thoughts of harming myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Deep Brain Stimulation (DBS) is applied to the dentato-rubro-thalamic tract (DRTt) to study structural and functional connectivity changes

During DBS placement surgery

Follow-up

Participants are monitored for changes in tremor and ataxia after DBS

72 hours

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation

Trial Overview The study is examining how Deep Brain Stimulation (DBS) of the dentato-rubro-thalamic tract affects both the physical connections within this brain region and its activity patterns to improve tremors in Essential Tremor patients.

How Is the Trial Designed?

Group I: Deep Brain Stimulation(DBS) Experimental Treatment 1 Intervention

Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain
• Stroke-related motor deficits (under investigation)

Approved in European Union as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain

Approved in Canada as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

In a comparison of deep brain stimulation (DBS) techniques for essential tremor, posterior subthalamic area (PSA) DBS showed significantly greater improvement in tremor suppression than ventral intermediate nucleus (VIM) DBS, with a follow-up period averaging around 12-15 months across 23 studies involving 448 patients.

PSA DBS also demonstrated a lower rate of stimulation-related complications compared to VIM DBS, indicating that PSA DBS may be a safer option for patients with essential tremor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which one is the superior target? A comparison and pooled analysis between posterior subthalamic area and ventral intermediate nucleus deep brain stimulation for essential tremor. Fan, H., Bai, Y., Yin, Z., et al.[2022]

Deep brain stimulation (DBS) is an effective treatment for Parkinson's disease, allowing patients to reduce their reliance on anti-Parkinson medications and save an average of $2,292 per year after surgery, based on a study of 72 patients.

While DBS is generally safe, the most common adverse event was intracranial hemorrhage occurring in 12.5% of patients, with a small percentage experiencing permanent or transient deficits, indicating that while effective, there are risks associated with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for Parkinson's disease: the Vanderbilt University Medical Center experience, 1998-2004. Gill, CE., Konrad, PE., Davis, TL., et al.[2007]

In a study of 19 patients with essential tremor, thalamic deep brain stimulation (DBS) showed a significant initial improvement in activities of daily living (ADL) at 1 year, but this benefit diminished over 7 years, except for the ability to eat.

Despite a decrease in DBS efficacy on tremor over time, patients still experienced improvements in social life and some aspects of health-related quality of life (HRQoL), indicating that DBS continues to provide relevant benefits even as other factors like aging and co-morbidities affect overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effect of deep brain stimulation for essential tremor on activities of daily living and health-related quality of life. Hariz, GM., Blomstedt, P., Koskinen, LO.[2022]

Deep-brain stimulation (DBS) targeting the ventral intermediate (VIM) nucleus and posterior subthalamic area (PSA) is shown to be a safe and effective treatment for patients with medically refractory essential tremor (ET), improving tremor reduction and daily activities.

While both DBS targets are effective, the literature on PSA is limited, particularly regarding bilateral stimulation and long-term outcomes, indicating a need for further research to compare the safety and efficacy of these targets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current clinical application of deep-brain stimulation for essential tremor. Chopra, A., Klassen, BT., Stead, M.[2022]

Deep brain stimulation (DBS) shows long-term efficacy in controlling essential tremor, with significant reductions in Tremor Rating Scale scores from a mean of 7 to 3 after treatment, based on a follow-up of 41 months for 26 patients.

Quality of life improved significantly with DBS, as indicated by a decrease in ADL Taxonomy scores from a mean of 26 to 12, and the effectiveness of DBS remained consistent regardless of the duration of follow-up, indicating sustained benefits over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of deep brain stimulation for essential tremor with subjective and objective quantification via mailed-in questionnaires. de Oliveira, TH., Ginsberg, MR., Cooper, S., et al.[2015]

A study involving 16 essential tremor patients demonstrated that deep brain stimulation (DBS) can be optimized by using local field potentials (LFPs) to detect voluntary movements and postural tremor, allowing for on-demand stimulation rather than continuous delivery.

The machine learning classifier achieved an average sensitivity of 80% in detecting movements and tremors, indicating that specific brain oscillatory activities in the beta and theta frequency bands are key to accurately decoding these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decoding voluntary movements and postural tremor based on thalamic LFPs as a basis for closed-loop stimulation for essential tremor. Tan, H., Debarros, J., He, S., et al.[2023]

Deep brain stimulation (DBS) has been shown to significantly improve symptoms in patients with essential tremor, with 430 patients studied, indicating its potential effectiveness for this movement disorder.

Most adverse events related to DBS were mild and manageable by adjusting stimulation settings, suggesting that DBS is a relatively safe treatment option for essential tremor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for essential tremor: a systematic review. Flora, ED., Perera, CL., Cameron, AL., et al.[2022]

Deep brain stimulation (DBS) is a safe and effective surgical treatment for advanced Parkinson's disease, with a low incidence of serious complications, as shown in a study of 130 patients over several years.

In this study, 62% of patients experienced no complications, and the most common issues were minor, such as aborted procedures (5.14%) and seizures (4.7%), indicating that DBS has a favorable safety profile compared to other surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. Seijo, FJ., Alvarez-Vega, MA., Gutierrez, JC., et al.[2019]

Deep brain stimulation (DBS) effectively reduces tremors and improves disability in both essential tremor (ET) and Parkinson's disease (PD) patients, with significant improvements observed across various tremor types, including proximal and distal postural tremors.

The study found that while all tremor types improved significantly with DBS, the greatest improvement in disability was linked to reductions in postural tremors, indicating that DBS is a viable treatment option for both ET and PD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of thalamic deep brain stimulation based on tremor type and diagnosis. Hubble, JP., Busenbark, KL., Wilkinson, S., et al.[2006]

Deep brain stimulation (DBS) is a reversible and adjustable treatment that has largely replaced traditional ablation procedures for movement disorders, showing therapeutic effects by modulating deep brain nuclei.

The most common targets for DBS include the subthalamic nucleus for advanced Parkinson's disease, the ventral intermediate nucleus of the thalamus for essential tremor, and the globus pallidus interna for dystonias, with varying clinical outcomes based on the target and stimulation parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of movement disorders by deep brain stimulation. Yu, H., Neimat, JS.[2022]

Deep brain stimulation (DBS) is an effective treatment for essential tremor (ET) that does not respond to medication, with evolving technologies improving its application and delivery.

Alternative targets for DBS, such as the posterior subthalamic area and zona incerta, may offer benefits but could also lead to more side effects, highlighting the need for careful consideration in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation in essential tremor: targets, technology, and a comprehensive review of clinical outcomes. Wong, JK., Hess, CW., Almeida, L., et al.[2021]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

Citations

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

Deep brain stimulation for essential tremor: a systematic ... Generally, in all studies, there was a significant improvement in outcomes after DBS compared with baseline scores. In addition, DBS was significantly better in ...

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

Deep Brain Stimulation for Tremor: Update on Long-Term ... The most common stimulation induced side effects were dysarthria (11%), paresthesia (6%), hemiparesis (6%) and headache (7%) [34]. These studies, including a ...

3. 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923005561

Deep Brain Stimulation and Tremor Significant improvements in upper extremity, head, and voice tremor have been consistently reported, both initially and up to 7 years after surgery.

5. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mdc3.70274

One Side or Two? A Systematic Review of Deep Brain ... Axial tremor improves by up to 60% with unilateral VIM DBS and a further 60% after bilateral surgery. Bilateral VIM DBS is linked to more AEs, ...

6. neurology.org neurology.org/doi/10.1212/WNL.0000000000208628

Real-world Clinical Outcomes from a Prospective ... Results from this registry demonstrate significant improvement in ET related symptoms and quality-of-life up to 12-month follow-up.

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

Prevalence and incidence of Deep Brain Stimulation ... Deep Brain Stimulation (DBS) and Focused Ultrasound Thalamotomy (FUS) are important surgical alternatives for managing essential tremor (ET).