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Neuromodulation Device

Non-Invasive Brainstem Stimulation for Parkinson's Disease

N/A
Recruiting
Led By Christopher T Whitlow, MD, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be 21-85 years old
Diagnosed with Parkinson's Disease
Must not have
Cannot attend all study visits (4 on-site visits) or complete all study activities
Heart attack, angina, or stroke within the past year
Timeline
Screening 1 day
Treatment 3 months
Follow Up 5 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will help to understand why some treatments for PD help with symptoms, even though we don't know how they work.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from wearing the device or issues related to MRIs such as claustrophobia or reactions in those with metal implants (though these individuals would be excluded).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 85 years old.
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I have been diagnosed with Parkinson's Disease.
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My Parkinson's symptoms have improved with medication for over 3 years.
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I can use the trial device as instructed.
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I am between 21 and 85 years old.
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I have been diagnosed with Parkinson's Disease.
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My Parkinson's symptoms have improved with medication for over 3 years.
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I can use the trial device as instructed.
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I can undergo 3 MRI scans, each lasting 1.5 hours.
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I have been on Parkinson's medication for 3 years or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I can attend all 4 required on-site visits and complete study activities.
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I have not had a heart attack, angina, or stroke in the last year.
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I use medication to control my heart rate.
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I am undergoing deep brain stimulation therapy.
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I use a pump for continuous dopamine therapy.
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I use Apomorphine for sudden symptoms.
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I do not have major health issues like stroke or Alzheimer's.
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I do not have a history of unstable mood disorders or suicidal behavior.
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I have had ringing in my ears for over 3 months.
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I have ongoing symptoms from a traumatic brain injury.
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I have been diagnosed with a balance disorder.
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I have not had ear surgery in the last 6 months.
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I currently have an ear infection or a problem with my eardrum.
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I have had at least one ear infection each year for the last two years.
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I take medication for nausea or vomiting more than twice a week.
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I am experiencing lasting symptoms from COVID-19.
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I am scheduled for a surgery during the trial that needs sedation or pain management.
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I am not pregnant and do not plan to become pregnant during the study.

Timeline

Screening ~ 1 day
Treatment ~ 3 months
Follow Up ~5 weeks
This trial's timeline: 1 day for screening, 3 months for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in cerebral blood flow (CBF) perfusion
Change in cerebrovascular Reactivity
Secondary study objectives
Change in functional connectivity
Other study objectives
Change in Arterial Stiffness
Change in cerebral haemodynamics
Change in the Epworth Sleepiness Scale
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment 2Experimental Treatment1 Intervention
Participants will receive Experimental treatment 2 stimulation for a duration of 12 weeks, twice daily for 19 minutes
Group II: Treatment 1Experimental Treatment1 Intervention
Participants will receive Experimental treatment 1 stimulation for a duration of 12 weeks, twice daily for 19 minutes

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,394 Previous Clinical Trials
2,460,016 Total Patients Enrolled
Christopher T Whitlow, MD, PhDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
41 Total Patients Enrolled

Media Library

Non-invasive brainstem stimulation (Neuromodulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04598828 — N/A
Parkinson's Disease Research Study Groups: Treatment 1, Treatment 2
Parkinson's Disease Clinical Trial 2023: Non-invasive brainstem stimulation Highlights & Side Effects. Trial Name: NCT04598828 — N/A
Non-invasive brainstem stimulation (Neuromodulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04598828 — N/A
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04598828 — N/A
~5 spots leftby Nov 2025
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