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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
Timeline
Screening 1 day
Treatment 3 months
Follow Up 5 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
My Parkinson's symptoms have improved with medication for over 3 years.
Select...
I can use the trial device as instructed.
Select...
I can undergo 3 MRI scans, each lasting 1.5 hours.
Timeline
Screening ~ 1 day1 visit
Treatment ~ 3 months4 visits
Follow Up ~ 5 weeks1 visit
Screening ~ 1 day
Treatment ~ 3 months
Follow Up ~5 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cerebral blood flow (CBF) perfusion
Change in cerebrovascular Reactivity
Secondary outcome measures
Change in functional connectivity
Other outcome measures
Change in Arterial Stiffness
Change in cerebral haemodynamics
Change in the Epworth Sleepiness Scale
+10 moreTrial 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
1,243 Previous Clinical Trials
1,004,706 Total Patients Enrolled
Christopher T Whitlow, MD, PhDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
41 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 use a pump for continuous dopamine therapy.I use Apomorphine for sudden symptoms.I do not have major health issues like stroke or Alzheimer's.I have had ringing in my ears for over 3 months.I have ongoing symptoms from a traumatic brain injury.I have been diagnosed with a balance disorder.I have not had ear surgery in the last 6 months.I currently have an ear infection or a problem with my eardrum.I take medication for nausea or vomiting more than twice a week.I am experiencing lasting symptoms from COVID-19.I am scheduled for a surgery during the trial that needs sedation or pain management.I can become pregnant and agree to use birth control and take a pregnancy test.I am undergoing deep brain stimulation therapy.I have had at least one ear infection each year for the last two years.I am willing to discuss my sexual health with the study staff.I experience a moderate amount of movement and non-movement related symptoms.I do not have a history of unstable mood disorders or suicidal behavior.My Parkinson's symptoms have improved with medication for over 3 years.I agree to be videotaped during my motor skills check-up.I have been diagnosed with Parkinson's Disease.I am not pregnant and do not plan to become pregnant during the study.I can attend all 4 required on-site visits and complete study activities.I have not had eye surgery in the last 3 months.My Parkinson's symptoms have improved with medication for over 3 years.I am between 21 and 85 years old.I have been diagnosed with Parkinson's Disease.I have not had a heart attack, angina, or stroke in the last year.I can use the trial device as instructed.I can use the trial device as instructed.I am between 21 and 85 years old.I use medication to control my heart rate.I have been on Parkinson's medication for 3 years or more.I can undergo 3 MRI scans, each lasting 1.5 hours.You are within driving distance of Atrium Health Wake Forest Baptist (Winston-Salem, NC).You have a study partner/regular caregiver that is willing to participate in the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment 1
- Group 2: Treatment 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 5 Weeks after you stop receiving the treatment.
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04598828 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial currently accepting enrollees?
"Affirmative. Evidence posted on clinicaltrials.gov shows that this medical trial, which was initially published on July 6th 2021, is looking for volunteers. A total of 22 individuals are being sought from 1 institution."
Answered by AI
Might I be a suitable participant for this clinical experiment?
"This medical trial is welcoming 22 patients with a diagnosis of Parkinson's disease between the ages of 21 and 85. To pass eligibility requirements, individuals must have access to 3 MRI sessions (of 1.5 hours each), display an intermediate level of motor symptoms, have a designated caregiver willing to participate in the study, be within driving distance from Atrium Health Wake Forest Baptist Hospital located in Winston-Salem (NC), respond adequately to medication for at least three years, demonstrate proficiency when using investigational devices , understand and complete all assessments exclusively provided in English language as well as consenting to being recorded during their motor examination visit."
Answered by AI
Does this clinical trial permit the enrollment of geriatric individuals?
"This trial could benefit from the participation of individuals aged 21 to 85. There are 27 studies for those younger than 18, and 485 opportunities available to those exceeding 65 years old."
Answered by AI
How many individuals are currently involved in this research project?
"Confirmed. The information on clinicaltrials.gov reveals that this research is actively seeking volunteers, having been first posted on July 6th 2021 and last updated on August 23rd 2022. 22 individuals will be recruited from a single trial site location."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
North Carolina
How old are they?
65+
What site did they apply to?
Wake Forest Health Sciences
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
I am in decline and need help. I am in decline and need help I also need.
PatientReceived 1 prior treatment
I'm taking Sinemet and find I have good days and bad days while on the drug - meaning it works sometimes and other times it does not. I have problems with tremors, handwriting and mobility.
PatientReceived no prior treatments
I am currently taking carbodopa/levodopa three times daily as well as blood pressure and cholesterol lowering meds. I walk 10 miles weekly, and stationary bike 8 miles weekly, and do recommended stretching exercises. I am interested in doing new approaches that might delay the the further stages on PD. I am currently stage one with a tremor in right arm. I also have been diagnosed with Charcot, Marie, Tooth disorder. Had a TIA six years ago.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
When does the trial start and how long does it last? Is there any financial compensation for travel/time?
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Phone Call
Most responsive sites:
- Wake Forest Health Sciences: < 24 hours
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