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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05205772
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • transcranial magnetic stimulation — DEVICE
    Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research. iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.

Study Details

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.

Key Dates

Start date
Feb 1, 2022
Status verified
May 2025
Primary completion
Jul 30, 2024
Completion
Jul 30, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: medial prefrontal cortex - control site - dorsolateral prefrontal cortex
    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.
  • Experimental: medial prefrontal cortex - dorsolateral prefrontal cortex - control site
    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.
  • Experimental: dorsolateral prefrontal cortex - medial prefrontal cortex - control site
    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.
  • Experimental: dorsolateral prefrontal cortex - control site - medial prefrontal cortex
    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.
  • Experimental: control site - medial prefrontal cortex - dorsolateral prefrontal cortex
    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.
  • Experimental: control site - dorsolateral prefrontal cortex - medial prefrontal cortex
    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.

Primary Outcome Measure

Change in Frontal Midline Theta EEG Power After Brain Stimulation [ Time Frame: At least 30 minutes before initial iTBS, and 30 minutes after each iTBS treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina School of MedicineChapel HillNorth Carolina27599-

Find similar trials in Chapel Hill, NC

By condition
DepressionParkinson's disease
By specialty
PsychiatryMental healthBehavioral healthNeurologyBrain disorders
By research site
University of North Carolina School of Medicine· Chapel Hill, NC

Related Studies