Subcortical Stimulation for Parkinson's Disease

Overseen By Nader Pouratian, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must be taking: L-dopa

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Amnestic cognitive deficits, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how subcortical stimulation, a type of brain treatment, can assist people with Parkinson's disease. The goal is to understand its effects on brain functions related to starting and stopping movements, which are often challenging for those with this condition. Researchers will study patients already scheduled for deep brain stimulation surgery to assess how this treatment might improve movement control. Individuals with Parkinson's disease experiencing noticeable movement issues and planning to undergo this surgery might be suitable candidates for the trial.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance treatment options for Parkinson's disease.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients should not have used anticoagulant or antiplatelet agents within one week before the trial.

What prior data suggests that subcortical stimulation is safe for Parkinson's disease patients?

Research has shown that deep brain stimulation (DBS), a type of brain treatment, is generally safe for people with Parkinson's disease. One study found that over five years, patients experienced significant improvements in their symptoms. DBS poses low risk when patients are carefully selected, although it might slightly increase hospital visits.

Another study found that serious side effects from DBS are rare. Most patients tolerate the procedure well, and it can enhance movement, mood, and quality of life. While DBS does not halt disease progression, it helps manage symptoms for an extended period. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Parkinson's disease, which often include medications like Levodopa and physical therapy, subcortical stimulation targets the brain directly. This unique approach involves deep brain stimulation (DBS) that can modulate brain activity precisely where it's needed, potentially improving movement disorders more effectively. Researchers are excited because this method could offer more consistent and long-term relief from symptoms, addressing the condition at its neurological roots rather than just managing symptoms. This could mean a significant improvement in quality of life for Parkinson's patients.

What evidence suggests that subcortical stimulation might be an effective treatment for Parkinson's Disease?

Studies have shown that deep brain stimulation (DBS) can greatly improve movement problems in people with Parkinson's disease. Research also suggests that this treatment can boost mood and overall quality of life. Patients who have had Parkinson's for about 5 to 10 years often see the best results. DBS targets specific brain areas to better control movements. Although effective, results can vary among individuals, possibly due to changes in the brain as the disease progresses. Participants in this trial will undergo subcortical DBS stimulation to assess its effects on movement and behavior. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Parkinson's disease, specifically those who respond to L-dopa treatment and are set to undergo deep brain stimulation surgery. Participants should be able to cooperate during an awake surgical procedure.

Inclusion Criteria

I have Parkinson's disease with symptoms like tremor or stiffness.

I am approved for deep brain stimulation surgery.

My Parkinson's symptoms improve significantly when I take my medication.

Exclusion Criteria

Neurocognitive testing indicating amnestic cognitive deficits (MOCA < 24)

I have used blood thinners or anti-clotting medications in the last week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intra-operative Assessment

Participants undergo deep brain stimulation surgery and complete behavioral assessments while receiving subcortical DBS stimulation. Cortical ECoG and subcortical LFP recordings are conducted.

Intra-operative

Follow-up

Participants are monitored for safety and effectiveness after the surgery and assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Subcortical Stimulation

Trial Overview

The study investigates how the brain controls actions in people with Parkinson's by recording brain activity during subcortical stimulation in a conscious state during deep brain stimulation surgery.

How Is the Trial Designed?

Group I: Parkinson's disease patients Experimental Treatment 1 Intervention

This group consists of Parkinson's disease patients who are undergoing deep brain stimulation surgery for treatment of their movement disorder. Participants will complete behavioral assessments while receiving subcortical DBS stimulation.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

Published Research Related to This Trial

In a study of 26 elderly patients with Parkinson's disease undergoing subthalamic deep brain stimulation (STN-DBS), there was a higher incidence of serious adverse events, particularly psychosis and hallucinations, compared to younger patients from the EARLYSTIM study.

Despite these psychiatric complications being transient, the overall benefits of STN-DBS in improving Parkinson's symptoms were found to outweigh the risks, highlighting the importance of thorough psychiatric evaluations before and after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Candidates for Subthalamic Deep Brain Stimulation in Parkinson's Disease Have a Higher Incidence of Psychiatric Serious Adverse Events. Cozac, VV., Ehrensperger, MM., Gschwandtner, U., et al.[2020]

In a study of 69 patients with advanced Parkinson's disease who underwent deep brain stimulation (DBS), 53% of those with subthalamic nucleus (STN) stimulation reported ongoing adverse events (AEs) four years post-surgery, compared to 35% in the internal globus pallidus (GPi) group.

Most AEs were not severe and affected cognitive, psychiatric, and motor functions, with a notable correlation between the presence of AEs and longer disease duration and pre-existing gait and psychiatric issues in STN DBS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter study on deep brain stimulation in Parkinson's disease: an independent assessment of reported adverse events at 4 years. Hariz, MI., Rehncrona, S., Quinn, NP., et al.[2008]

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) in patients with advanced Parkinson's disease showed significant long-term motor improvement, with a 66% enhancement in motor function maintained five years post-surgery.

While STN-DBS effectively improved motor symptoms, there was a notable decline in axial symptoms and an increase in dementia cases over five years, suggesting that while DBS is beneficial for motor control, its long-term effects on cognitive health and axial symptoms require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation of the subthalamic nucleus in advanced Parkinson's disease: five year follow-up at a Portuguese center. Monteiro, A., Andrade, C., Rosas, MJ., et al.[2014]

The study involved 20 patients with Parkinson's disease and 20 healthy controls, using deep brain stimulation to explore how different pathways in the brain affect motor control and cognitive adaptation during movement tasks.

Findings indicate that while deep brain stimulation can modulate motor functions, it does not fully restore cognitive flexibility or kinematic control, suggesting that targeted stimulation strategies could enhance treatment efficacy and reduce side effects in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional segregation of basal ganglia pathways in Parkinson's disease. Neumann, WJ., Schroll, H., de Almeida Marcelino, AL., et al.[2019]

Citations

1.

nature.com

nature.com/articles/s41467-025-60695-4

Boundary complexity of cortical and subcortical areas ...

Despite its efficacy in alleviating PD motor symptoms in many patients, outcomes following DBS exhibit significant variability, with instances ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39711571

Boundary Complexity of (Sub-) Cortical Areas Predict Deep ...

These findings demonstrate that PD effects on brain morphology linked to disease progression influence DBS outcomes.

3.

journals.plos.org

journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004670

Deep brain stimulation surgical timing, outcomes, and ...

DBS significantly improved motor, mood, and quality-of-life outcomes across all PD durations, with the most substantial benefits observed in mid-duration (5–10 ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1878875020313048

Subcortical Atrophy and Motor Outcomes in Pallidal Deep ...

Data from 34 patients with PD who were treated with GPi-targeted DBS were evaluated. Age was found to exhibit statistically significant positive correlations ...

5.

jneurosci.org

jneurosci.org/content/43/45/7575

Advances in Deep Brain Stimulation: From Mechanisms to ...

(2023) Personalized chronic adaptive deep brain stimulation outperforms conventional stimulation in Parkinson's disease. medRxiv 23293450 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12439180/

Five-Year Outcomes from Deep Brain Stimulation of the ...

This cohort study evaluates 5-year outcomes and safety of subthalamic nucleus deep brain stimulation for the treatment of Parkinson disease.

7.

nature.com

nature.com/articles/s43856-025-00744-7

Accelerated symptom improvement in Parkinson's disease ...

The safety endpoint of the ROAM-DBS trial was the rate of stimulation optimization-related serious adverse events (SAEs) in the two study arms ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10690827/

Deep brain stimulation in PD: risk of complications ...

It is found that, when candidates are carefully screened, DBS is a relatively low-risk procedure, but rate of hospitalization is somewhat increased for DBS ...

9.

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 ...