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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04598828
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 85 Years
Healthy Volunteers
Not accepted

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.

Study Details

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)

Key Dates

Start date
Jul 6, 2021
Status verified
Jun 2025
Primary completion
Oct 2, 2023
Completion
Oct 7, 2024

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment 1
    Participants will receive Experimental treatment 1 stimulation for a duration of 12 weeks, twice daily for 19 minutes
  • Experimental: Treatment 2
    Participants will receive Experimental treatment 2 stimulation for a duration of 12 weeks, twice daily for 19 minutes

Primary Outcome Measure

Cerebral Blood Flow (CBF) Perfusion [ Time Frame: baseline ]

Locations (1)

FacilityCityStateZIP
Wake Forest Health SciencesWinston-SalemNorth Carolina27157

Find similar trials in Winston-Salem, NC

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Wake Forest Health Sciences· Winston-Salem, NC

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