Apathy in Parkinson Disease TMS Study

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

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06087926
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Stimulation (TMS) — 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. TMS is FDA approved for the 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). 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 treatment lasts approximately 3 minutes.

Study Details

The goal of this clinical trial is to develop non-invasive brain stimulation targets for the treatment of apathy, or motivation problems, in Parkinson Disease. The main questions the study aims to answer are: 1. Does transcranial magnetic stimulation change effort task performance in Parkinson's Disease patients? 2. Is there a link between brain signals and apathy? Participants will * complete questionnaires and assessments * perform an effort task * have their brain activity recorded (EEG) * receive non-invasive brain stimulation (TMS) Researchers will compare two stimulation locations (experimental site and control site) to see if TMS of the experimental site has an effect on apathy. Participants will receive stimulation of both sites (during separate visits).

Key Dates

Start date
May 1, 2024
Status verified
May 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Medial 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 control site.
  • Experimental: Control Site - 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 medial prefrontal cortex.

Primary Outcome Measure

Change in goal-directed behavior after transcranial magnetic stimulation (TMS) [ Time Frame: Immediately before stimulation and 15 minutes after stimulation. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UNC-Chapel Hill, Cassidy LabChapel HillNorth Carolina27599
Monica Coudurier

Find similar trials in Chapel Hill, NC

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
UNC-Chapel Hill, Cassidy Lab· Chapel Hill, NC

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