Parkinson DiseaseNCT04598828
Use of a Non-Invasive Brainstem Neuromodulation Device to Improve Neurovascular Status in Parkinson's Disease
A study testing Non-invasive brainstem stimulation in people with Parkinson Disease, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Non-invasive brainstem stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2021to 7 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 21-85 years old
- Diagnosed with Parkinson's Disease
- Within driving distance of Atrium Health Wake Forest Baptist (Winston-Salem, NC)
- Responsive to Parkinson's medication for a minimum of 3 years
- Have ability to reliably use the investigational device
- Understand and complete all assessments (provided in English only)
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- Be able to have 3 separate MRI scans (1.5 hours per MRI)
- Have a study partner/regular caregiver that is willing to participate in the trial
- Demonstrate moderate burden of motor symptoms and non-motor symptoms
- Consent to being videotaped during motor examination visit
- Willing to answer questions related to sexual interest, arousal and performance in an interview with study staff
Who cannot join
- Cannot attend all study visits (4 on-site visits) or complete all study activities
- Heart attack, angina, or stroke within the past year
- Use medications that regulate heart rate
- Have a history or prior diagnosis of dementia
- Receiving deep brain stimulation therapy
- Treated with a pump for continuous delivery of dopamine replacement therapy
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- Use of Apomorphine rescue
- Works night shifts
- Have any significant co-morbidity such as stroke, brain tumor, epilepsy, Alzheimer's disease, multiple sclerosis, ALS, atypical Parkinsonism, or aneurysm
- History or evidence of unstable mood disorder or demonstrates evidence of suicidality
- Hearing aids that are implanted or cannot be easily removed and replaced, such as cochlear implants
- Chronic ringing in the ears for more than 3 months
- Diagnosed with traumatic brain injury with ongoing symptoms
- Recent history of substance abuse and/or dependence (alcohol or other drugs)
- Diagnosed balance dysfunction
- Eye surgery within the previous 3 months
- Ear surgery within the previous 6 months
- Active ear infection, perforated tympanic membrane, or inner ear inflammation
- Recent history of frequent ear infections (≥ 1 per year over the past two years)
- Contraindications for MRI scans, such as metal implants or a pacemaker
- Currently enrolled or have participated in another interventional clinical trial within the last 30 days
- Taking medication for vomiting or nausea more than 2 times per week, consistently
- Ongoing symptoms from a COVID-19 infection that includes one or more of the exclusion criteria listed above
- Planned surgery scheduled to occur during the clinical trial that requires sedation and/or would typically be followed with a prescription for pain management
- Women who are pregnant or plan to become pregnant during the the study
- Women of child-bearing potential (i.e., are not yet 3 years removed from their first menopausal symptom), who are not abstinent or exclusively in same sex relationships must:
- Test negative for pregnancy as indicated by a negative urine pregnancy test
- Agree to use an approved contraception method
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Using Time Varying Non-Invasive Neuromodulation to Improve Neurovascular Status in Parkinson's Disease
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)
Read the detailed description
Patients treating twice daily using a non-invasive brainstem modulation device. Study participants will self-administer treatments in the home setting over a period of 12 weeks. Changes in cerebral blood flow perfusion, cerebrovascular reactivity and functional connectivity between the pre-treatment baseline and the end of the treatment period will be monitored and compared to changes in validated standardized clinical measures of motor and non-motor symptoms in PD.
- Conditions
- Parkinson Disease
- Being tested
- Non-invasive brainstem stimulation
- Keywords
- balance disorders, motor functions
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive brainstem stimulationDevice
Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration.
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Participants will receive Experimental treatment 1 stimulation for a duration of 12 weeks, twice daily for 19 minutes Receives: Device: Non-invasive brainstem stimulation |
| Treatment 2 | Experimental | Participants will receive Experimental treatment 2 stimulation for a duration of 12 weeks, twice daily for 19 minutes Receives: Device: Non-invasive brainstem stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Blood Flow (CBF) Perfusion
Cerebral blood flow (CBF) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion
Measured: baseline
Cerebral Blood Flow (CBF) Perfusion
Cerebral blood flow (CBF) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion
Measured: end of treatment (week 12)
Cerebrovascular Reactivity
Cerebral blood flow is measured with pCASL MRI at baseline and during hypercapnic challenge. The percent change in CBF is divided by the increase in end-tidal CO2 measured in mmHg, measured with RespirACT system
Measured: baseline
Cerebrovascular Reactivity
Cerebral blood flow is measured with pCASL MRI at baseline and during hypercapnic challenge. The percent change in CBF is divided by the increase in end-tidal CO2 measured in mmHg, measured with RespirACT system
Measured: end of treatment (week 12)
Secondary outcomes (1)
Percent Change in Functional Connectivity
Changes to the within-network connectivity of the DMN (Default Mode Network)
Measured: baseline and end of treatment (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start6 Jul 2021
- Primary completion2 Oct 2023
- Study completion7 Oct 2024
Why it stopped: Lack of activity and not meeting recruitment goals within expected timeframe
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- Christopher T Whitlow, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598828
- Sponsor's protocol ID
- IRB00067408
- Status last verified
- Jun 2025
- First submitted
- 16 Oct 2020
- Last updated
- 14 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Time Varying Non-Invasive Neuromodulation to Improve Neurovascular Status in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04598828
- Acronym / sponsor ID
- IRB00067408
- Conditions
- Parkinson Disease
- Keywords
- balance disorders, motor functions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of activity and not meeting recruitment goals within expected timeframe
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 14 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Patients treating twice daily using a non-invasive brainstem modulation device. Study participants will self-administer treatments in the home setting over a period of 12 weeks. Changes in cerebral blood flow perfusion, cerebrovascular reactivity and functional connectivity between the pre-treatment baseline and the end of the treatment period will be monitored and compared to changes in validated standardized clinical measures of motor and non-motor symptoms in PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Device: Non-invasive brainstem stimulationParticipants will receive Experimental treatment 1 stimulation for a duration of 12 weeks, twice daily for 19 minutes |
| Treatment 2 | Experimental | Device: Non-invasive brainstem stimulationParticipants will receive Experimental treatment 2 stimulation for a duration of 12 weeks, twice daily for 19 minutes |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Must be 21-85 years old
- Diagnosed with Parkinson's Disease
- Within driving distance of Atrium Health Wake Forest Baptist (Winston-Salem, NC)
- Responsive to Parkinson's medication for a minimum of 3 years
- Have ability to reliably use the investigational device
Key exclusion criteria (28 listed)
- Cannot attend all study visits (4 on-site visits) or complete all study activities
- Heart attack, angina, or stroke within the past year
- Use medications that regulate heart rate
- Have a history or prior diagnosis of dementia
- Receiving deep brain stimulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive brainstem stimulationStudy participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration. | Device | Treatment 1, Treatment 2 |
Primary outcome
Cerebral Blood Flow (CBF) Perfusion
Time frame: baseline
Cerebral blood flow (CBF) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion
Cerebral Blood Flow (CBF) Perfusion
Time frame: end of treatment (week 12)
Cerebral blood flow (CBF) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion
Cerebrovascular Reactivity
Time frame: baseline
Cerebral blood flow is measured with pCASL MRI at baseline and during hypercapnic challenge. The percent change in CBF is divided by the increase in end-tidal CO2 measured in mmHg, measured with RespirACT system
Cerebrovascular Reactivity
Time frame: end of treatment (week 12)
Cerebral blood flow is measured with pCASL MRI at baseline and during hypercapnic challenge. The percent change in CBF is divided by the increase in end-tidal CO2 measured in mmHg, measured with RespirACT system
1 secondary outcome
Percent Change in Functional Connectivity
Time frame: baseline and end of treatment (week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher T Whitlow, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive brainstem stimulation in people with Parkinson Disease, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Blood Flow (CBF) Perfusion (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.