Low Voltage Electrical Stimulation for Depression in Parkinson's Patients (LVESDIPP)

April 1, 2026 updated by: University of South Alabama

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

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study seeks to expand the growing body of literature on the use of a particular type of low voltage electrical stimulation known as Transcranial Direct Current Stimulation (TDCS) to reduce the symptoms of Parkinson's Disease (PD). One common disorder that can result from, and/or be exacerbated by PD is Major Depressive Disorder. In particular, apathy has been noted as a common and detrimental component for those with PD. While many studies have been performed on PD patients using TDCS, the consensus in the literature is that results are widely variable.

Participants will:

  • complete self-report measures and neuropsychological tests
  • undergo eeg recording pre and post intervention
  • participate in 15, 46 minute sessions (2 13 minute stimulation sessions with 20 minutes of rest between) of mgTDCS over the course of 4-5 weeks Researchers will compare active mgTDCS to Sham mgTDCS to see if active mgTDCS is more effective. A non Parkinson's group of depressed controls who are age-matched to the PD patients will serve to determine if treatment effects are specific to PD or generalize to depression more generally.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36688
        • Recruiting
        • University of South Alabama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: BIOPAC Stimsola
Transcranial Electrical Stimulator
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.
Device: BIOPAC Stimsola Sham (zero amps)
Transcranial Electrical Stimulator set to 0 amps

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The BDI, a self-report measure for assessing depression, has high internal consistency (Cronbach's alpha > .90) and good test-retest reliability.
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.
Alpha band power from pre-post eeg records will be assessed for power changes at frontal sites.
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.
Digit Span and Story Memory subtests will be used to determine changes in working memory.
One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PDQ-39
Time Frame: One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.
This a common measure to assess patient quality of life in Parkinson Disease patients involved in research.
One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Alabama

Investigators

  • Principal Investigator: John Shelley-Tremblay, PhD, 2514606883

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2128181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe