Clinical trial NCT05205772: Investigating Central Neurophysiologic Correlates of Non-Motor Symptoms of Parkinson's Disease
Official title: Investigating Central Neurophysiologic Correlates of Non-Motor Symptoms of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Autonomic Dysfunction
Depression
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.

Primary outcomes:
measure: Change in Frontal Midline Theta EEG Power After Brain Stimulation
timeFrame: At least 30 minutes before initial iTBS, and 30 minutes after each iTBS treatment
measure: Correlation Between the Scales for Outcomes in Parkinson's Disease - Autonomic (SCOPA-AUT) Total Score and EEG
timeFrame: At least 30 minutes before initial iTBS
measure: Correlation Between the Orthostatic Hypotension Questionnaire (OHQ) and EEG
timeFrame: At least 30 minutes before initial iTBS
measure: Correlation Between Degree of Orthostatic Hypotension and EEG
timeFrame: At least 30 minutes before initial iTBS
Secondary outcomes:
Other outcomes:
measure: SCOPA-AUT Response to Brain Stimulation
timeFrame: 30 minutes pre-iTBS, and 1 day and 4 days after each iTBS treatment
measure: OHQ Response to Brain Stimulation
timeFrame: At least 30 minutes pre-iTBS, and day 1 and day 4 after each iTBS treatment
measure: Response of Orthostatic Blood Pressure Changes to Brain Stimulation
timeFrame: At least 30 minutes before each iTBS treatment, and 30 minutes after each iTBS treatment
measure: Depression Symptom Response to Brain Stimulation
timeFrame: At least 30 minutes before each iTBS treatment, and day 1 and day 4 after each iTBS treatment
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Miriam Sklerov, MD
role: PRINCIPAL_INVESTIGATOR
References: