72 Participants Needed

Deep Brain Stimulation for Essential Tremor

Recruiting at 1 trial location
RR
MA
Overseen ByMark Amandola
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwell Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment Deep Brain Stimulation for Essential Tremor?

Research shows that Deep Brain Stimulation (DBS) is effective in reducing tremors and improving daily life activities for people with essential tremor. Studies indicate significant improvements in tremor scores and disability ratings, with DBS being equally effective for essential tremor and Parkinson's disease.12345

Is deep brain stimulation (DBS) generally safe for humans?

Deep brain stimulation (DBS) is generally considered safe, with most adverse events being mild and manageable. Common complications include infections and lead migrations, and some cases may require additional surgery. However, it is one of the safest treatments for conditions like Parkinson's disease and essential tremor.678910

How is deep brain stimulation different from other treatments for essential tremor?

Deep brain stimulation (DBS) is unique because it involves implanting electrodes in specific brain areas to modulate abnormal signals, offering a reversible and adjustable treatment option for essential tremor, unlike traditional medications or surgical ablation procedures.1241112

What is the purpose of this trial?

The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation

Research Team

AJ

Albert J Fenoy, MD

Principal Investigator

Northwell Health

Eligibility Criteria

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.
See 1 more

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.
See 7 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Deep Brain Stimulation(DBS)Experimental Treatment1 Intervention

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

πŸ‡ΊπŸ‡Έ
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)
πŸ‡ͺπŸ‡Ί
Approved in European Union as Deep Brain Stimulation for:
  • Essential tremor
  • Parkinson's disease
  • Dystonia
  • Obsessive-compulsive disorder
  • Epilepsy
  • Chronic pain
πŸ‡¨πŸ‡¦
Approved in Canada as Deep Brain Stimulation for:
  • Essential tremor
  • Parkinson's disease
  • Dystonia
  • Obsessive-compulsive disorder
  • Epilepsy
  • Chronic pain

Find a Clinic Near You

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+

Findings from Research

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.
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]
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.
Current clinical application of deep-brain stimulation for essential tremor.Chopra, A., Klassen, BT., Stead, M.[2022]
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.
Effects of thalamic deep brain stimulation based on tremor type and diagnosis.Hubble, JP., Busenbark, KL., Wilkinson, S., et al.[2006]

References

Long-term effects of deep brain stimulation for essential tremor with subjective and objective quantification via mailed-in questionnaires. [2015]
Current clinical application of deep-brain stimulation for essential tremor. [2022]
Effects of thalamic deep brain stimulation based on tremor type and diagnosis. [2006]
Deep brain stimulation in essential tremor: targets, technology, and a comprehensive review of clinical outcomes. [2021]
Long-term effect of deep brain stimulation for essential tremor on activities of daily living and health-related quality of life. [2022]
Deep brain stimulation for essential tremor: a systematic review. [2022]
Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]
Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. [2019]
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. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Deep brain stimulation for Parkinson's disease: the Vanderbilt University Medical Center experience, 1998-2004. [2007]
11.United Statespubmed.ncbi.nlm.nih.gov
Decoding voluntary movements and postural tremor based on thalamic LFPs as a basis for closed-loop stimulation for essential tremor. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
The treatment of movement disorders by deep brain stimulation. [2022]
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