Investigating Central Neurophysiologic Correlates of Non-Motor Symptoms of Parkinson's Disease

NCT05205772•University of North Carolina, Chapel Hill

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 autonomic dysfunction and depression. Participants will undergo TMS to three brain regions: medial prefrontal cortex (mPFC) (experimental site), dorsolateral prefrontal cortex (DLPFC) (alternative experimental site), or primary sensory cortex (S1) (control site) in a triple crossover design. Participants will complete symptom questionnaires, neurologic examination and cognitive assessments, and orthostatic vital signs recording before and after each brain stimulation session.

Eligibility

Age

50 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.

Locations (1)

University of North Carolina School of Medicine

Chapel Hill, North Carolina, United States

Key Dates

Start Date

February 1, 2022

Primary Completion Date

July 30, 2024

Completion Date

July 30, 2024

Last Updated

May 21, 2025

Enrollment

ACTUAL participants

Conditions

Parkinson DiseaseAutonomic DysfunctionDepression

Interventions

transcranial magnetic stimulation

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Investigating Central Neurophysiologic Correlates of Non-Motor Symptoms of Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

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Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

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