Directional vs. Nondirectional DBS for Essential Tremor

Overseen By Zoe Fanning

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Secondary tremor, Dystonia, Ataxia, Parkinsonism, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of deep brain stimulation (DBS) for treating essential tremor, a condition that usually causes shaking in the hands. The researchers aim to determine if directional DBS, which targets specific areas, is more effective and has fewer side effects, such as speech or balance issues, compared to nondirectional DBS. Suitable participants have experienced tremors in both arms for at least three years and have not undergone certain brain surgeries or used specific devices. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance treatment options for essential tremor.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this deep brain stimulation technique is safe for treating essential tremor?

Research has shown that both directional and nondirectional deep brain stimulation (DBS) can safely treat essential tremor. In directional DBS, one study found that 24% of patients experienced some side effects, though these were usually manageable. Directional leads can also help many patients avoid side effects.

For nondirectional DBS, most patients experienced only mild issues, with no severe problems reported. Studies also highlight that both types of DBS significantly reduce tremor symptoms, with improvements lasting over a year.

Overall, DBS is a well-established treatment for essential tremor, and both methods are generally well-tolerated. However, like any medical procedure, some risks exist. Discuss these with a doctor to find the best option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore new ways to deliver deep brain stimulation (DBS) for essential tremor. Unlike traditional DBS, which usually provides nondirectional stimulation, this approach looks at both directional and nondirectional methods. Directional DBS targets specific areas in the brain with more precision, potentially improving effectiveness and minimizing side effects. This could offer a more personalized treatment option for patients struggling with essential tremor, making it a promising development in neurology.

What evidence suggests that this trial's treatments could be effective for essential tremor?

Research has shown that deep brain stimulation (DBS) can greatly improve symptoms of essential tremor (ET). In this trial, participants will receive either directional or nondirectional DBS. For the directional DBS arm, studies have found it reduces tremors by 53.4% to 62.8% after 12 months. This approach also improves hand function and lessens the impact of tremors. Meanwhile, the nondirectional DBS arm has also shown good results in easing symptoms and reducing side effects. Both treatments effectively manage tremors, but directional DBS might offer a larger therapeutic window, meaning it can work well with fewer side effects on speech, walking, and balance. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for people with essential tremor in both arms lasting over 3 years, who haven't had relief from other treatments and are considering deep brain stimulation (DBS). It's not for those with tremors due to drugs or other neurological conditions, nor for patients with a history of DBS or thalamotomy, pacemakers, or certain medical procedures.

Inclusion Criteria

You have been experiencing shaking in both of your arms for at least 3 years.

Exclusion Criteria

You have orthostatic tremor.

You have had deep brain stimulation in the past.

You have had thalamotomy surgery in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either directional or nondirectional deep brain stimulation to assess therapeutic window, speech, gait, and balance

3 months

Regular visits for monitoring and adjustments

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 of the VIM Thalamic nuclei

Trial Overview The study at OHSU is testing if directional DBS provides better control of essential tremor compared to nondirectional DBS. The goal is to see if it can treat the tremor more effectively while reducing unwanted effects on speech, walking and balance.

How Is the Trial Designed?

Group I: Directional deep brain stimulation Active Control 1 Intervention

Deep brain stimulation delivered in a directional manner within an axial plane

Group II: Nondirectional deep brain stimulation Active Control 1 Intervention

Deep brain stimulation delivered in a nondirectional manner within an axial plane

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Citations

1. 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 ...

2. 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 ...

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

Deep brain stimulation for the treatment of tremor A recent systematic review of 40 studies showed that tremor reduction after unilateral Vim-DBS for ET ranged from 53.4 to 62.8% at 12 months ...

4. 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 ...

5. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(21)02157-7/fulltext

Bipolar Directional Deep Brain Stimulation in Essential and ... In line with previous evidence (19), both bipolar settings were as effective in suppressing tremor as monopolar DBS, albeit at significantly higher amplitudes.

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

Deep Brain Stimulation for Tremor: Update on Long-Term ... In a recent meta-analysis, stimulation-induced adverse events were most prevalent in Vim-DBS (24%), followed by device-related (12%) and surgical-related (6%) ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715921000830

Tremor and Quality of Life in Patients With Advanced ... Our data imply that the use of directional leads can improve tremor and tremor-related quality of life in advanced essential tremor patients.

9. cureus.com cureus.com/articles/344641-directional-deep-brain-stimulation-programming-in-parkinsons-disease-and-essential-tremor-patients-an-institution-based-study

Directional Deep Brain Stimulation Programming in ... Similarly, among ET patients, 64% (7/11) used directional programming to avoid side effects, and 33% (4/12) experienced improved tremor control ...

10. jnnp.bmj.com jnnp.bmj.com/content/90/4/474

Outcomes from stereotactic surgery for essential tremor DBS was the most commonly reported treatment for ET. One-year tremor reductions ranged from 53% to 63% with unilateral Vim DBS.