Deep Brain Stimulation for Essential Tremor and Parkinson's Disease

Overseen By Cierra Clark, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jorge Gonzalez-Martinez

Disqualifiers: Seizure history, Bilateral tremors, Others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Deep Brain Stimulation (DBS), which involves electrical impulses to the brain, affects movement, speech, and swallowing in individuals with movement disorders like Essential Tremor and Parkinson's Disease. The researchers aim to understand how different DBS settings impact these functions. Participants will perform tasks to measure movement speed, grip strength, and other functions both with and without the stimulation. The trial seeks individuals who already have a DBS device implanted to manage their movement disorder symptoms but continue to experience issues with speech or swallowing.

As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance DBS settings for better management of movement disorders.

Do I need to stop 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 study team or your doctor.

What prior data suggests that Deep Brain Stimulation is safe for movement disorders?

Research has shown that Deep Brain Stimulation (DBS) in the motor thalamus is a safe treatment for people with essential tremor and Parkinson’s disease. Studies tracking patients for over 13 years have found that DBS works well and is generally well-tolerated. Many patients have experienced improvements in symptoms like shaking and stiffness.

In one study of over 1,000 people with Parkinson's disease, symptoms improved by 50%, and daily activities became easier by 52%. This indicates that DBS is helpful and usually safe. However, some people might find that the effects decrease over time.

It's important to remember that while DBS has shown good results, individual responses can differ. Always consult a healthcare provider about the potential risks and benefits before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for essential tremor and Parkinson's disease, like medications or physical therapy, aim to manage symptoms rather than address the root cause. But Deep Brain Stimulation (DBS) works differently, targeting specific areas in the brain, such as the motor thalamus, to modulate abnormal brain activity responsible for movement disorders. This precise approach can lead to significant improvements in symptoms that are hard to control with standard treatments. Researchers are excited about DBS because it offers a customizable and potentially more effective solution, especially for patients who do not respond adequately to medication. Additionally, by understanding how DBS affects speech, swallowing, and motor functions, this trial could optimize the therapy to enhance quality of life further.

What evidence suggests that Deep Brain Stimulation is effective for movement disorders?

Research has shown that Deep Brain Stimulation (DBS) effectively reduces tremors in individuals with Essential Tremor and Parkinson's Disease. In this trial, participants will receive DBS targeting the motor thalamus, which studies have found to offer long-term benefits, with significant improvements in movement lasting up to ten years after the procedure. Specifically, DBS targeting the thalamus helps control tremors, with evidence supporting its effectiveness for at least six years. Additionally, individuals with Parkinson's Disease have experienced over a 50% improvement in movement abilities with DBS treatment. Although DBS does not halt disease progression, it provides lasting relief from movement problems, significantly enhancing quality of life. ^{2 6 7 8 9}

Who Is on the Research Team?

Jorge Gonzalez-Martinez, MD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults under 80 with movement disorders who will receive or have received Deep Brain Stimulation (DBS), and healthy volunteers of the same age range. Pregnant or breastfeeding women, those with bilateral tremors, a history of fainting or seizures, severe cognitive issues, or serious diseases are excluded.

Inclusion Criteria

HEALTHY CONTROLS: Subject has provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, where applicable, prior to any study-related procedures

HEALTHY CONTROLS: Subject is willing and able to comply with scheduled visits and study procedures

I am younger than 80 years old.

Exclusion Criteria

I am currently pregnant or breastfeeding.

I do not have tremors in both sides of my body.

ALL PATIENTS: Patients with vasovagal response history and loss of consciousness history will be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo multiple sessions performing motor, speech, and swallowing tasks with DBS parameters adjusted prior to testing

2 years

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 (DBS)

Trial Overview The study tests how DBS of the Motor Thalamus affects motor functions like movement speed and grip strength in patients with various brain-related movement disorders. It involves tasks performed both with and without stimulation to assess changes.

How Is the Trial Designed?

Group I: Deep Brain Stimulation of the Motor Thalamus Experimental Treatment 1 Intervention

Individuals with deep brain stimulation device implanted in the motor thalamus for movement disorders treatment who also sustain speech, swallowing, and motor deficits.

Group II: Healthy Control Participants Active Control 1 Intervention

The investigators aim to include healthy control subjects who will complete the language and upper-limb tasks. The healthy subjects will not undergo any surgical procedures.

Who Is Running the Clinical Trial?

Jorge Gonzalez-Martinez

Lead Sponsor

Trials

1

Recruited

10+

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Citations

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

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3382386/

Deep Brain Stimulation for Parkinson's Disease and Other ... There is Level 3a evidence that DBS of the thalamus is effective in the control of tremor in patients with essential tremor and PD for at least 6 years. There ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715924001284

How Long Does Deep Brain Stimulation Give Patients ... We showed that patients with PD, ET, and dystonia maintain a considerable long-term benefit in motor scores seven to ten years after implant, although the ...

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

One Side or Two? A Systematic Review of Deep Brain ... The results showed that bilateral STN DBS improved the mean total Unified Parkinson's Disease Rating Scale (UPDRS) motor score by 54%, whereas ...

5. thejns.org thejns.org/view/journals/j-neurosurg/132/1/article-p205.xml

Long-term outcomes following deep brain stimulation for ... DBS for PD is associated with a 10-year survival rate of 51%. Survey data suggest that while DBS does not halt disease progression in PD, it provides durable ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24096713/

The safety and efficacy of thalamic deep brain stimulation ... Conclusions: Thalamic DBS is a safe and effective therapy in patients with essential tremor followed for up to 13 years. Keywords: ELECTRICAL STIMULATION; ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923020299

The role of the motor thalamus in deep brain stimulation for ... Taken together, DBS offers promising outcomes for ET, with the PSA emerging as a better target for suppression of tremor symptoms. While advanced imaging ...

8. nature.com nature.com/articles/s41467-024-48731-1

Deep brain stimulation of symptom-specific networks in ... Deep Brain Stimulation can improve tremor, bradykinesia, rigidity, and axial symptoms in patients with Parkinson's disease.

9. neurology.org neurology.org/doi/10.1212/01.WNL.0000096012.07360.1C

Long-term follow-up of thalamic deep brain stimulation for ... Two of five patients with essential tremor had contralateral tremor improvement after ongoing stimulation for 2 years; two developed marked tolerance to DBS.