Status:
COMPLETED
Investigating Central Neurophysiologic Correlates of Non-Motor Symptoms of Parkinson's Disease
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Parkinson Disease
Autonomic Dysfunction
Eligibility:
All Genders
50-90 years
Phase:
NA
Brief Summary
This is a randomized, single-blinded, triple crossover study focused on determining the feasibility of using transcranial magnetic stimulation (TMS) for treatment of Parkinson's disease related autono...
Eligibility Criteria
Inclusion
- Men and women between 50 and 90 years of age, without a diagnosis of severe dementia
- Carry a diagnosis of idiopathic Parkinson's disease based on the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria
- Have had symptoms of Parkinson's disease for at least 3 years
- Hospital's study-specific informed consent must be obtained
- Must have capacity to provide informed consent in English
- For female participants, confirmation that a menstrual period has not occurred in over 12 months, or that an effective form of contraception will be used during the study
Exclusion
- Inability to provide informed consent.
- Severe dementia
- History of epilepsy or brain surgery
- Severe tremor or dyskinesia that would interfere with EEG as determined by the PI
- Parkinson's patients with clinically significant medical or neurological conditions which may be an alternative cause of orthostatic hypotension, such as neuropathy, renal failure, heart failure, cardiac arrhythmias, severe diabetes, or spinal cord injuries
- The investigators will exclude patients who are treated with medications which can significantly lower blood pressure or heart rate, such as antihypertensive medications, diuretics, and alpha-blocking medications
- Presence of other known central nervous system disease that may interfere with performance or interpretation of EEG or TMS
- Presence of any implanted metal devices including, but not limited to, pacemakers, deep brain stimulators, vagal nerve stimulators, bladder stimulators, or cochlear implants.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05205772
Start Date
February 1 2022
End Date
July 30 2024
Last Update
May 21 2025
Active Locations (1)
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1
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27599