NCT05205772Completed
Investigating Central Neurophysiologic Correlates of Non-Motor Symptoms of Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 21 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 2 Dec 2021
- Start date
- 1 Feb 2022
- Primary completion date
- 30 Jul 2024
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Parkinson disease
- NCT number
- NCT05205772
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 1 Feb 2022 to the primary completion date, 30 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 any implanted metal devices including, but not limited to, pacemakers, deep brain stimulators, vagal nerve stimulators, bladder stimulators, or cochlear implants.
Other illness
- Severe dementia
- History of epilepsy or brain surgery
- 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
- Presence of other known central nervous system disease that may interfere with performance or interpretation of EEG or TMS
Other
- Inability to provide informed consent.
- Severe tremor or dyskinesia that would interfere with EEG as determined by the PI
Who the study is looking for
- 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
Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina School of Medicine Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.