Recruiting

mgTDCS

Sponsor:

University of South Alabama

Code:

NCT06467695

Conditions

Parkinson Disease

Depressive Symptoms

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Not accepted

Interventions

BIOPAC Stimsola

BIOPAC Stimsola Sham (zero amps)

Study Details

Brief 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?

Conditions

Parkinson Disease

Depressive Symptoms

Study ID

NCT06467695

Start date

Aug 1, 2024

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • No history of or being treated for epilepsy or other seizure disorders.
  • No history of penetrating head wounds or TBI greater than mild TBI.
  • No history of atypical Parkinson's

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

BIOPAC Stimsola

Transcranial Electrical Stimulator

BIOPAC Stimsola Sham (zero amps)

Transcranial Electrical Stimulator set to 0 amps

Primary outcome measure

  • Beck Depression Inventory (BDI) Pre-post change score [ Time Frame: One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start. ]
  • Alpha band power pre-post change score [ Time Frame: One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start. ]
  • RBANS Working Memory [ Time Frame: One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start. ]

Central Contacts and Locations

Central contacts

John F Shelley-Tremblay, PhD

2514606883jstremblay@southalabama.edu

Benjamin D Hill, PhD

251-460-6546bdhill@southalabama.edu

Locations

University of South Alabama

Recruiting

Mobile, Alabama, United States, 36688

More Information

Sponsor

University of South Alabama

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Keywords

  • Direct Transcranial Current Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Alabama on 2026-04-06.