Non-Invasive Brainstem Stimulation for Parkinson's Disease

Overseen By Christopher T Whitlow, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Parkinson's medication

Must not be taking: Heart rate regulators, Apomorphine

Disqualifiers: Dementia, Stroke, Epilepsy, Alzheimer's, others

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

Compensation: Varies

Number of Visits: 17

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new non-invasive brainstem stimulation treatment for Parkinson's disease. The researchers aim to understand how this treatment alleviates symptoms such as movement difficulties and other non-motor issues. Participants will receive one of two experimental treatments, each involving 19-minute sessions twice a day for 12 weeks. Suitable candidates have a Parkinson's disease diagnosis, respond well to medication, and reside near Winston-Salem, NC. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future Parkinson's disease treatments.

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

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use medications that regulate heart rate or take medication for vomiting or nausea more than twice a week.

What prior data suggests that this non-invasive brainstem stimulation is safe for Parkinson's disease?

Research has shown that non-invasive brainstem stimulation for Parkinson's disease is generally well-tolerated. Studies have found that this treatment can alter brain activity without causing major side effects. Although researchers continue to study it, no serious safety issues have been consistently reported.

Some patients experienced mild side effects, such as headaches or tingling sensations, but these typically resolved quickly. Overall, current evidence suggests that non-invasive brainstem stimulation is safe. However, more research is needed to fully understand its long-term safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about non-invasive brainstem stimulation for Parkinson's disease because it offers a fresh approach compared to traditional treatments like medications that boost dopamine. Unlike standard drugs, which often come with side effects, this method uses gentle electrical pulses to target the brainstem, potentially improving symptoms without the need for medication. This approach is non-invasive, meaning it doesn't require surgery or medication, and it could provide relief with fewer side effects. By potentially altering brain activity directly, it offers a novel way to manage Parkinson's symptoms that could enhance patients' quality of life.

What evidence suggests that this non-invasive brainstem stimulation is effective for Parkinson's disease?

Research has shown that non-invasive brainstem stimulation can help alleviate symptoms of Parkinson's disease. In this trial, participants will receive either Experimental treatment 1 or Experimental treatment 2, both involving non-invasive brainstem stimulation. Studies have found that this type of stimulation can enhance movement and motor skills in people with Parkinson's, though it may not significantly impact balance. Animal studies also suggest that these techniques can reduce movement problems related to Parkinson's. Overall, this treatment appears promising for managing some symptoms of the disease. ^{1 2 6 7 8}

Who Is on the Research Team?

Christopher T Whitlow, MD, PhD, MHA

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults aged 21-85 with Parkinson's Disease, who've responded to PD medication for at least 3 years and can handle the study device. Participants must have a caregiver willing to join, live near Winston-Salem, NC, speak English, and be able to undergo MRI scans. Exclusions include unstable mood disorders, certain ear conditions or surgeries, recent heart events or surgery plans during the trial period.

Inclusion Criteria

I experience a moderate amount of movement and non-movement related symptoms.

I can undergo 3 MRI scans, each lasting 1.5 hours.

Within driving distance of Atrium Health Wake Forest Baptist (Winston-Salem, NC)

Exclusion Criteria

I use a pump for continuous dopamine therapy.

I use Apomorphine for sudden symptoms.

Works night shifts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-administer treatments using a non-invasive brainstem modulation device twice daily for 12 weeks

12 weeks

Home-based self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

Post-treatment assessments at week 17

What Are the Treatments Tested in This Trial?

Interventions

• Non-invasive brainstem stimulation

Trial Overview

The study tests a non-invasive brainstem stimulation device on people with Parkinson's Disease in a controlled setting where neither participants nor researchers know who receives the real treatment versus a placebo. The goal is to understand how this device might alleviate symptoms of PD.

How Is the Trial Designed?

Group I: Treatment 2 Experimental Treatment 1 Intervention

Participants will receive Experimental treatment 2 stimulation for a duration of 12 weeks, twice daily for 19 minutes

Group II: Treatment 1 Experimental Treatment 1 Intervention

Participants will receive Experimental treatment 1 stimulation for a duration of 12 weeks, twice daily for 19 minutes

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Trials

117

Recruited

537,000+

Published Research Related to This Trial

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 (DBS) is effective for treating motor symptoms of Parkinson's disease, particularly when targeting the subthalamic nucleus and globus pallidus internus, which consistently improve motor features.

While some non-motor symptoms also show improvement with DBS, further research is needed to understand these effects better and to explore other deep brain targets like the pedunculopontine nucleus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. Fasano, A., Daniele, A., Albanese, A.[2022]

Citations

1.

nature.com

nature.com/articles/s41531-025-00908-1

Non-invasive brain stimulation to modulate neural activity ...

We here review recent findings that illustrate how various non-invasive stimulation techniques can modify pathological and compensatory activities.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10487610/

Noninvasive Neuromodulation in Parkinson's Disease

In summary, studies in animal models of PD have demonstrated that lf-rTMS, hf-rTMS, and iTBS attenuate the PD-related motor deficits and concomitantly reduce ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11982587/

Exploring Non-invasive Brain Stimulation Effects on ...

NIBS offers small-to-moderate benefits for motor symptoms and functional movement in PD, though it does not significantly impact balance.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1878747923020263

Emerging therapies for neuromodulation in Parkinson's ...

In this review, we will discuss the current approaches used to modulate basal ganglia output using invasive and non-invasive techniques. These approaches now ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04797611

Study Details | NCT04797611 | STEM-Parkinson's Disease

This is a double-blinded, controlled, and randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01615718

Non-invasive Neurostimulation in Parkinson's Disease | ...

Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0165027020303800

Non-invasive brain stimulation for Parkinson's disease

The non-invasive brain stimulation (NIBS) may offer a complementary approach to treat advanced PD by personalized stimulation.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9896761/

Safety and tolerability of adjunct non-invasive vagus nerve ...

Non-invasive vagus nerve stimulation in parkinson's disease: current status and future prospects. Expert Rev Med Devices. 2021 doi: 10.1080 ...