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

15 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Non-invasive brainstem stimulation for Parkinson's Disease?

Recent studies suggest that non-invasive brain stimulation (NIBS) shows promising outcomes in treating Parkinson's disease symptoms, although it is not as effective as the standard medication levodopa. Some NIBS methods have improved symptoms, and new technology may soon allow for more effective stimulation of deeper brain areas. ^{1 2 3 4 5}

How does non-invasive brainstem stimulation differ from other treatments for Parkinson's disease?

Non-invasive brainstem stimulation is unique because it does not require surgery or implanted devices, unlike deep brain stimulation (DBS), which involves surgically placing electrodes in the brain. This non-invasive approach may offer a less risky and more accessible option for patients. ^{3 4 6 7 8}

What is the purpose of this trial?

This study is a single-site, double-blinded, randomized clinical trial designed to elucidate mechanism(s) of action for symptomatic benefits observed in Parkinson's disease (PD)

Research Team

Christopher T Whitlow, MD, PhD, MHA

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.

I am willing to discuss my sexual health with the study staff.

Exclusion Criteria

I use a pump for continuous dopamine therapy.

I use Apomorphine for sudden symptoms.

Works night shifts

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Deep brain stimulation in movement and psychiatric disorders. [2007]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation for Parkinson's disease: Clinical evidence, latest concepts and future goals: A systematic review. [2021]

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

Earlier Intervention with Deep Brain Stimulation for Parkinson's Disease. [2022]

4. 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]

5. China pubmed.ncbi.nlm.nih.gov

Target Selection Recommendations Based on Impact of Deep Brain Stimulation Surgeries on Nonmotor Symptoms of Parkinson's Disease. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Chronic electrical stimulation of the VL-VPL complex and of the pallidum in the treatment of movement disorders: personal experience since 1982. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. [2022]

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

Implantation of bilateral deep brain stimulators in patients with Parkinson disease and preexisting cardiac pacemakers. Report of two cases. [2007]