Deep Brain Stimulation for Essential Tremor
(TRaNCE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how deep brain stimulation (DBS) affects brain activity in individuals with essential tremor, a condition causing uncontrollable shaking. Participants will either have electrodes placed on their scalp or sit inside a brain activity recording device, with their brain activity monitored in various states, including when the DBS device is turned on and off. The study also tests other tremor management methods, such as cooling the limb, taking medication, drinking alcohol, or stimulating nerves. Individuals who have had essential tremor for at least three years, with or without a DBS implant, or have no neurological disorder might be suitable candidates for this study. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could improve tremor management strategies.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking medications with Antabuse-like effects, you will be excluded from any alcohol administration during the trial.
What prior data suggests that this protocol is safe for participants?
Research has shown that deep brain stimulation (DBS) for essential tremor is generally safe and well-tolerated. In a review of 430 patients who underwent DBS, most reported side effects were mild and manageable. Another study followed patients for up to 12 months after DBS and found significant improvements in symptoms and quality of life. While some side effects can occur, they are usually not serious and can be treated effectively. This indicates that DBS is a reliable option for those dealing with essential tremor, with a strong safety record.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how deep brain stimulation (DBS) affects the brain's functional networks in people with essential tremor (ET). Unlike standard medications like propranolol or primidone, which manage symptoms by altering brain chemistry, DBS directly targets the brain's electrical activity to reduce tremors. By understanding how DBS changes brain networks, this trial could lead to more precise and effective treatments for ET, potentially offering hope to those who haven't found relief with conventional therapies.
What evidence suggests that this trial's techniques could be effective for essential tremor?
This trial will compare participants with essential tremor who have previously received a deep brain stimulation (DBS) system to those who have not. Studies have shown that DBS effectively treats essential tremor, with patients experiencing significant improvements in tremor control and hand function. These benefits can persist for many years after treatment. Research indicates that DBS can enhance quality of life by reducing tremor symptoms without causing major cognitive issues. Overall, strong evidence supports the effectiveness of DBS in managing essential tremor.16789
Who Is on the Research Team?
James Liao, MD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Data Collection
Electrophysiological data collection using EEG or MEG, with DBS OFF and ON states, and optional non-DBS tremor mitigation techniques
Follow-up
Participants are monitored for safety and effectiveness after data collection
What Are the Treatments Tested in This Trial?
Interventions
- Alcohol
- Alprazolam
- Cold Therapy
- Peripheral Nerve Stimulation
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
1. 30-80 years of age 2. No known neurological disease or disorder
1. 30-80 years of age 2. Diagnosis of ET 3. Has not been previously implanted with a DBS system for disease management per standard of care
1. 30-80 years of age 2. Diagnosis of ET 3. Previously implanted with a DBS system for disease management per standard of care
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
Citations
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 ...
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 ...
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 ...
How Long Does Deep Brain Stimulation Give Patients ...
Results. We showed that patients with PD, ET, and dystonia maintain a considerable long-term benefit in motor scores seven to ten years after implant, ...
5.
frontiersin.org
frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2020.578348/fullCognitive Outcomes for Essential Tremor Patients Selected ...
In this large cohort of ET patients with (>30% improvements), DBS was not accompanied by a significant decline in many cognitive domains.
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.
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 ...
Safety and Efficacy of Staged, Bilateral Focused ...
These results are consistent with observations that bilateral deep brain stimulation treatment often better controls head and voice tremor.
9.
movementdisorders.onlinelibrary.wiley.com
movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mdc3.70274One Side or Two? A Systematic Review of Deep Brain ...
noted a 63% improvement in contralateral symptoms (tremor 88%, rigidity 60%, bradykinesia 54%) and a 15% improvement in ipsilateral symptoms ( ...
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