Investigation of Non-invasive Brain Stimulation for the Treatment of Apathy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 80
Healthy Volunteers: f
View:

• Diagnosis of idiopathic Parkinson Disease.

• At least 5 years of symptoms.

• On dopaminergic medication for Parkinson Disease.

• Stable on dopaminergic medication and other medications which may influence apathy (such as selective serotonin re-uptake inhibitors, stimulant medications) for at least 4 weeks prior to first study visit and remain stable throughout the study period.

• Hospital's study-specific informed consent must be obtained.

• Must have capacity to provide informed consent in English.

• For female participants, confirmation that they have not had a menstrual period in over 12 months, or that they will use an effective form of contraception during the study.

Locations
United States
North Carolina
UNC-Chapel Hill, Cassidy Lab
RECRUITING
Chapel Hill
Contact Information
Primary
Anita Frohlich, LL.M.
frohlicha@neurology.unc.edu
919-843-6880
Backup
Miriam Sklerov, MD
miri@email.unc.edu
984-974-4401
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov