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

  • STATUS
    Recruiting
  • End date
    Dec 18, 2023
  • participants needed
    22
  • sponsor
    Wake Forest University Health Sciences
Updated on 6 June 2022
dopamine
motor symptoms

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)

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.

Details
Condition Parkinson Disease, Parkinson's Disease, parkinson's disease
Treatment Non-invasive brainstem stimulation
Clinical Study IdentifierNCT04598828
SponsorWake Forest University Health Sciences
Last Modified on6 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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