Deep Brain Stimulation for Parkinson's Disease

Overseen By Christopher K Kovach, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Neurodegenerative disorder, Visual acuity, others

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

Compensation: Varies

Number of Visits: 4

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 tiny electrical impulses to specific brain areas, affects attention and perception in people with Parkinson's disease (PD) and essential tremor (ET). Researchers aim to determine whether DBS can improve or worsen the perception of social cues, such as facial expressions, and whether DBS can be fine-tuned to better manage these effects. Participants with PD or ET who are scheduled for a new DBS implant and can handle tasks during surgery might be suitable for this study.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance DBS treatment for future patients.

Will I have to stop taking my current medications?

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 deep brain stimulation is safe for Parkinson's disease and essential tremor?

Research has shown that deep brain stimulation (DBS) is generally well-tolerated by people with Parkinson's disease. Studies have found that when patients are carefully selected, DBS presents a relatively low risk. However, patients undergoing the procedure have a slightly higher chance of hospitalization compared to those who do not.

One study that followed DBS outcomes over five years found that the treatment provided lasting relief from movement problems. While it does not halt the progression of Parkinson's disease, it offers ongoing benefits. Another study suggested that offering DBS during the moderate stages of the disease could provide the most lasting benefit.

Overall, DBS is considered safe for treating Parkinson's disease, particularly with careful patient selection. The procedure has been used for a long time and has shown good results in improving symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the acute alteration of Deep Brain Stimulation (DBS) for Parkinson's Disease because it explores how specific changes in DBS settings can influence brain function. Unlike standard treatments like medication or surgery that primarily target dopamine levels or brain structures, this approach aims to optimize DBS settings dynamically. By adjusting stimulation in real-time, this technique could offer more personalized and immediate symptom relief, potentially improving quality of life for patients more effectively than traditional methods.

What evidence suggests that deep brain stimulation is effective for Parkinson's disease?

Research has shown that deep brain stimulation (DBS) can greatly benefit people with Parkinson's disease (PD). Studies have found that DBS improves movement by 29% and boosts quality of life by 18% compared to the best available medications. It also reduces the need for medication, a significant advantage for those with PD. People who have undergone DBS report a better overall quality of life, with some improvements in focus and perception. While DBS does not stop PD from progressing, it helps manage symptoms and improve life quality. In this trial, all participants will experience acute alteration of DBS stimulation under three conditions in a randomized order. ^{2 6 7 8 9}

Who Is on the Research Team?

Christopher K Kovach, PhD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease (PD) or Essential Tremor (ET). Participants will be observed and tested before, during, and after starting Deep Brain Stimulation (DBS) therapy. The study aims to understand the impact of DBS on attention and perception related to social cues.

Inclusion Criteria

All Participants: Ability to express perceptual judgments through a button press or mouse-controlled computerized slider

I am between 19 and 90 years old.

I am willing and able to sign consent for this study.

Exclusion Criteria

All Participants: Corrected visual acuity insufficient to perceptually judge face stimuli

I understand and can follow task instructions.

I can understand and follow the study's instructions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-DBS Assessment

Participants undergo eye tracking and facial expression rating tasks before starting DBS therapy

1 hour

1 visit (in-person)

DBS Surgery

DBS electrodes are implanted while participants are awake, with microelectrode recordings taken

15 minutes

1 visit (in-person)

Post-DBS Assessment

Participants perform visual and perceptual tasks with varying DBS settings to evaluate cognitive and perceptual functions

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for changes in attention and perception 2-3 weeks after DBS surgery

2-3 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Attention and Eye Movement Study

Trial Overview The study investigates how different settings of DBS—reduced frequency, reduced current, and normal therapeutic levels—affect attention control in PD and ET patients. It uses eye tracking technology to assess changes in how participants perceive facial expressions.

How Is the Trial Designed?

Group I: Acute alteration of DBS Experimental Treatment 3 Interventions

All participants in the single arm of this study will undergo acute alteration of DBS stimulation under three conditions in randomized order over the course of 1 hour.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Published Research Related to This Trial

In a study of 40 Parkinson's disease patients undergoing subthalamic deep brain stimulation (STN-DBS), 45% reported significant improvement in sleep quality at 6 months, although this improvement was not statistically significant at 12 months.

The most common benefits included better overall sleep quality and maintenance, but some patients experienced new-onset daytime sleepiness, indicating that while STN-DBS can improve sleep, the effects can vary widely among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Parkinson's disease sleep symptoms and daytime somnolence after bilateral subthalamic deep brain stimulation in Parkinson's disease. Kharkar, S., Ellenbogen, JR., Samuel, M., et al.[2020]

Asleep deep brain stimulation (DBS) for Parkinson's disease showed a mean motor improvement of 52.3% on the Unified Parkinson's Disease Rating Scale, which is comparable to the 47.0% improvement seen in the awake group, suggesting that asleep DBS is an effective alternative.

The study found no serious complications related to the surgery, with only a subcutaneous hematoma reported, indicating that asleep DBS may be a safe option for patients undergoing this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease. Engelhardt, J., Caire, F., Damon-Perrière, N., et al.[2021]

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

Deep brain stimulation (DBS) is an important treatment option for Parkinson's disease, but estimating the prevalence and categorizing adverse events (AEs) associated with it is challenging due to inconsistent reporting.

The authors advocate for a standardized scheme for reporting AEs related to DBS, which would help in conducting meaningful risk/benefit analyses and assist both physicians and patients in making informed decisions about surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for Parkinson's disease: prevalence of adverse events and need for standardized reporting. Videnovic, A., Metman, LV.[2008]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

In a study of 319 patients treated with deep brain stimulation (DBS) for various movement disorders over a 10-year period, the procedure demonstrated a favorable safety profile with rare intraoperative adverse events, such as vasovagal response (2.5%) and syncope (1.2%).

Long-term complications were also relatively low, with persistent issues like dysarthria and cognitive dysfunction occurring in about 4% of patients, indicating that DBS is a safe option for treating medically refractory movement disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term and long-term safety of deep brain stimulation in the treatment of movement disorders. Kenney, C., Simpson, R., Hunter, C., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30660117/

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

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3843969/

Deep brain stimulation for the treatment of Parkinson's ... Off medication motor function (29%) and measures of quality of life (18%) were also improved for DBS compared with best medical therapy, but there was no ...

3. ufhealth.org ufhealth.org/news/2025/uf-led-study-shows-deep-brain-stimulation-benefits-for-parkinsons-patients

UF-led study shows deep brain stimulation benefits for ... For the first time, we can clearly see that the benefits of DBS, improvements in motor symptoms, reduced medication needs and better quality of ...

4. ohsu.edu ohsu.edu/brain-institute/dbs-outcomes

DBS Outcomes | Brain Institute Improved quality of life: The same study found a 26% improvement in quality-of-life scores among DBS patients, compared to a 1% decline in patients taking ...

5. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2838886

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.

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. 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 ...

8. parkinsonsnewstoday.com parkinsonsnewstoday.com/news/lasting-relief-parkinsons-motor-symptoms-found-dbs-us-study/

Lasting relief of Parkinson's motor symptoms found with DBS Deep brain stimulation, a surgical procedure known as DBS, provides relief of Parkinson's motor symptoms after five years, per a U.S. study.

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 ...