N/A
N=30
Investigating Central Neurophysiologic Correlates of Non-Motor Symptoms of Parkinson's Disease
Parkinson Disease · Autonomic Dysfunction · Depression
Bottom Line
View on ClinicalTrials.gov: NCT05205772 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Change in Frontal Midline Theta EEG Power After Brain Stimulation — 1.03; 0.44; 1.01 microvolts^2/Hz — p=0.08
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transcranial magnetic stimulation (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Frontal Midline Theta EEG Power After Brain Stimulation |
1.03; 0.44; 1.01 | 0.08 |
| PRIMARY Correlation Between the Scales for Outcomes in Parkinson's Disease - Autonomic (SCOPA-AUT) Total Score and EEG |
0.255 | 0.38 |
| PRIMARY Correlation Between the Orthostatic Hypotension Questionnaire (OHQ) and EEG |
0.261 | 0.67 |
| PRIMARY Correlation Between Degree of Orthostatic Hypotension and EEG |
0.429 | 0.156 |
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 Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05205772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.