Deep Brain Stimulation for Essential Tremor
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.12345Why 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.13567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Deep Brain Stimulation (DBS) is applied to the dentato-rubro-thalamic tract (DRTt) to study structural and functional connectivity changes
Follow-up
Participants are monitored for changes in tremor and ataxia after DBS
What Are the Treatments Tested in This Trial?
Interventions
- Deep Brain Stimulation
Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- Stroke-related motor deficits (under investigation)
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- 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
The University of Texas Health Science Center, Houston
Lead Sponsor
National Institutes of Health (NIH)
Collaborator