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

Not Applicable

Completed

• Conditions: Parkinson Disease; Autonomic Dysfunction; Depression

• Registration Number: NCT05205772
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-2
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Inclusion Criteria:<br><br> - Men and women between 50 and 90 years of age, without a diagnosis of severe dementia<br><br> - Carry a diagnosis of idiopathic Parkinson's disease based on the United Kingdom<br> Parkinson's Disease Society Brain Bank clinical diagnostic criteria<br><br> - Have had symptoms of Parkinson's disease for at least 3 years<br><br> - Hospital's study-specific informed consent must be obtained<br><br> - Must have capacity to provide informed consent in English<br><br> - For female participants, confirmation that a menstrual period has not occurred in<br> over 12 months, or that an effective form of contraception will be used during the<br> study<br><br>Exclusion Criteria:<br><br> - Inability to provide informed consent.<br><br> - Severe dementia<br><br> - History of epilepsy or brain surgery<br><br> - Severe tremor or dyskinesia that would interfere with EEG as determined by the PI<br><br> - Parkinson's patients with clinically significant medical or neurological conditions<br> which may be an alternative cause of orthostatic hypotension, such as neuropathy,<br> renal failure, heart failure, cardiac arrhythmias, severe diabetes, or spinal cord<br> injuries<br><br> - The investigators will exclude patients who are treated with medications which can<br> significantly lower blood pressure or heart rate, such as antihypertensive<br> medications, diuretics, and alpha-blocking medications<br><br> - Presence of other known central nervous system disease that may interfere with<br> performance or interpretation of EEG or TMS<br><br> - Presence of any implanted metal devices including, but not limited to, pacemakers,<br> deep brain stimulators, vagal nerve stimulators, bladder stimulators, or cochlear<br> implants.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in frontal midline theta EEG power after brain stimulation;Superiority of stimulation at the medial prefrontal cortex and dorsolateral prefrontal cortex over stimulation at the control site;Correlation between the SCales for Outcomes in Parkinson's disease - Autonomic (SCOPA-AUT) total score and EEG;Correlation between the Orthostatic Hypotension Questionnaire (OHQ) and EEG;Correlation between degree of orthostatic hypotension and EEG