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

University of North Carolina (UNC)

Status: Completed

Conditions: Parkinson Disease; Depression; Autonomic Dysfunction

Treatments: Device: transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05205772

21-0751

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 6 patient groups

medial prefrontal cortex - control site - dorsolateral prefrontal cortex

Experimental group

Description:

Participants first undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex.

Treatment:

Device: transcranial magnetic stimulation

medial prefrontal cortex - dorsolateral prefrontal cortex - control site

Experimental group

Description:

Participants first undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the control site.

Treatment:

Device: transcranial magnetic stimulation

dorsolateral prefrontal cortex - medial prefrontal cortex - control site

Experimental group

Description:

Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the control site.

Treatment:

Device: transcranial magnetic stimulation

dorsolateral prefrontal cortex - control site - medial prefrontal cortex

Experimental group

Description:

Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the medial prefrontal cortex.

Treatment:

Device: transcranial magnetic stimulation

control site - medial prefrontal cortex - dorsolateral prefrontal cortex

Experimental group

Description:

Participants first undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex.

Treatment:

Device: transcranial magnetic stimulation

control site - dorsolateral prefrontal cortex - medial prefrontal cortex

Experimental group

Description:

Participants first undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the medial prefrontal cortex.

Treatment:

Device: transcranial magnetic stimulation