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The Effect of MRI-Guided Transcranial Direct Current Stimulation on Cognitive and Affective Symptoms in Persons With Parkinson's Disease and Controls

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

The goal of this clinical trial is to determine the relative efficacy of fMRI model guided Transcranial Direct Current Stimulation (mgTDCS) in improving the depressive symptoms of patients with Parkinson's Disease (PD). The main questions it aims to answer are: 1) Can the use of mgTDCS significantly improve the self-reported level of depression and apathy in patients with PD from pre-intervention to post-intervention compared to a sham control? 2) Can the use of mgTDCS significantly normalize the cortical eeg alpha asymmetry so commonly seen in depressed patients compared to sham mgTDCS? 3) Can the use of mgTDCS significantly improve scores on neuropsychological tests of working memory?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 65
Healthy Volunteers: f
View:

• 19 to 65 years in age.

• Parkinson's Group must have a physician dx of Parkinson's Disease

• Must meet exhibit elevated levels of depression on the Beck Depression Inventory (scores of 20 or above).

• Must be willing and able to travel of the Psychology Department for EEG and tDCS sessions.

• Participants who have undergone surgery for Deep Brain Stimulation implantation may be enrolled if advised to and monitored by their physician.

• Read and understand spoken English.

Locations
United States
Alabama
University of South Alabama
RECRUITING
Mobile
Contact Information
Primary
John F Shelley-Tremblay, PhD
jstremblay@southalabama.edu
2514606883
Backup
Benjamin D Hill, PhD
bdhill@southalabama.edu
251-460-6546
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 40
Treatments
Experimental: Electrical Stimulation (experimental)
Transcranial Direct Current Stimulation will be administered in a high definition anodal montage at 2 milliamps with anode over T3 (adjusted for each participant) and cathode in an equidistance ring around it with 4 return electrodes. There will be 13 minutes of active stimulation followed by a twenty minute delay, followed by 13 minutes of stimulation. Participants in the pilot study will be administered 2 mA of current at a steady state with a 30 second ramp-up and ramp-down period at the beginning and end of each 13 minute stimulation interval.
Sham_comparator: Sham Stimulation
For the sham TDCS condition, 10 participants will receive receive sham tDCS consisting of 30 seconds of ramp-up and then the amperage will be reduced to 0 for the remainder of the session.
Related Therapeutic Areas
Sponsors
Leads: University of South Alabama

This content was sourced from clinicaltrials.gov