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NCT Number: NCT06467695

Low Voltage Electrical Stimulation for Depression in Parkinson's Patients

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?

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Alabama

Mobile, Alabama, 36688, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIOPAC Stimsola

Device

Transcranial Electrical Stimulator

BIOPAC Stimsola Sham (zero amps)

Device

Transcranial Electrical Stimulator set to 0 amps

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin D Hill, PhD

CONTACT

[email protected]

251-460-6546

John F Shelley-Tremblay, PhD

CONTACT

[email protected]

2514606883

Sponsors and collaborators

Lead sponsor

University of South Alabama

Other

Registry information

Official study title

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

Acronym: LVESDIPP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 21, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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