Use of a Non-Invasive Brainstem Neuromodulation Device to Improve Neurovascular Status in Parkinson's Disease

NCT04598828 | Terminated Results FDA Device

• 1 other identifier: IRB00067408
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Parkinson Disease

Keywords

balance disorders; motor functions

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  end of treatment (week 12)

Secondary Outcomes (1)

• Percent Change in Functional Connectivity

  baseline and end of treatment (week 12)

Other Outcomes (14)

• Change in Cerebral Haemodynamics

  baseline and end of treatment (week 12)

• Durability of Change of Cerebral Blood Flow (CBF) Perfusion

  baseline and the post-treatment follow-up (week 17)

• Durability of Change of Cerebrovascular Reactivity

  baseline and the post-treatment follow-up (week 17)

Study Arms (2)

Treatment 1

EXPERIMENTAL

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

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

Device: Non-invasive brainstem stimulation

Interventions

Non-invasive brainstem stimulation DEVICE

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.

Treatment 1; Treatment 2

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Project Manager
• Organization: Atrium Health Wake Forest Baptist

richarlette.hightower@advocatehealth.org

336-713-8793

Study Officials

• Christopher T Whitlow, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 22, 2020
• Study Start: July 6, 2021
• Primary Completion: October 2, 2023
• Study Completion: October 7, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)