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

138 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Attention and Eye Movement Study for Parkinson's Disease?

Research shows that deep brain stimulation (DBS) of the subthalamic nucleus (STN) is effective in improving motor symptoms in Parkinson's disease and can also affect eye movements and attention. Specifically, DBS at different frequencies can influence eye movement control, with 130 Hz stimulation reducing errors in eye movement tasks compared to 80 Hz. This suggests that DBS can help manage certain non-motor symptoms related to attention and eye movements in Parkinson's patients. ^{1 2 3 4 5}

Is deep brain stimulation generally safe for humans?

Deep brain stimulation (DBS) can have complications, with overall rates exceeding 25%, and permanent neurological issues occurring in 4-6% of cases. Common problems include infections, lead migrations, and device malfunctions, with some cases requiring additional surgery. ^{6 7 8 9 10}

How does deep brain stimulation differ from other treatments for Parkinson's disease?

Deep brain stimulation (DBS) for Parkinson's disease is unique because it involves implanting electrodes in the brain to send electrical impulses to specific areas, like the subthalamic nucleus, to improve motor function. Unlike medications that alter brain chemistry, DBS directly modulates brain activity and can be adjusted in real-time to optimize symptom control. ^{1 2 3 4 11}

What is the purpose of this trial?

The goal of this observational and interventional study is to understand how therapeutic deep brain stimulation (DBS) affects attention, perception and cognition in participants with Parkinson's disease (PD) and essential tremor (ET). The main questions it aims to answer are: * Does impaired control of attention and eye movement in PD alter how social cues are perceived and interpreted? * Does therapeutic DBS improve or worsen attentional and perceptual deficits for social cues in PD and ET? * Can DBS be optimized to restore normal attentional control in PD while remaining an effective therapy for other aspects of the disorder. * What do parts of the brain targeted by DBS contribute to the control of attention? Using an eye tracking camera, investigators will study how participants with PD and ET look at and perceive facial expressions of emotion before and after starting DBS therapy, in comparison to a group of healthy participants without ET, PD or DBS. Participants with PD and ET will see and rate morphed facial expressions on a computer screen in three conditions: * Before starting DBS therapy (over approximately 1 hour). * In the operating room, during the standard procedure to implant DBS electrodes, while the participant is awake (for no more than 15 minutes). * After starting DBS therapy, with brief experimental changes of DBS stimulation level and frequency (over approximately 1 hour).

Research Team

Christopher K Kovach, PhD

Principal Investigator

University of Nebraska

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of deep brain stimulation frequency on eye movements and cognitive control. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

STN-DBS Reduces Saccadic Hypometria but Not Visuospatial Bias in Parkinson's Disease Patients. [2020]

3. Poland pubmed.ncbi.nlm.nih.gov

Opposite effects of l-dopa and DBS-STN on saccadic eye movements in advanced Parkinson's disease. [2018]

4. United States 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. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Deep brain stimulation in Parkinson's disease: meta-analysis of randomized controlled trials. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Short-term and long-term safety of deep brain stimulation in the treatment of movement disorders. [2022]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. Switzerland pubmed.ncbi.nlm.nih.gov

A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Subthalamic stimulation improves orienting gaze movements in Parkinson's disease. [2018]