Low Voltage Electrical Stimulation for Depression in Parkinson's Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-09-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

tDCS for Treatment of Depression in Parkinson's Disease

NCT02960464

Idiopathic Parkinson Disease Depression

UNKNOWN NA

Magnetic Stimulation for Parkinson Disease

NCT00029276

Parkinson's Disease Depression

COMPLETED PHASE1

Comparison of Anodal Transcranial Direct Current Stimulation (t-DCS) and Sham Stimulation in Patients With Treatment-resistant Depression

NCT02141776

Major Depressive Disorder

COMPLETED PHASE4

Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation

NCT03074812

Idiopathic Parkinson's Disease Parkinson Disease Depression

SUSPENDED NA

tDCS in Parkinson's Disease With Depression

NCT02315781

Depression Parkinson's

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease Depressive Symptoms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants (n = 40) will be either in the Parkinson's Group (n = 20) or the No Parkinson's Control (N = 20). All patients will be randomly assigned to receive either tDCS or SHAM tDCS.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants will not be told whether they are receiving tDCS or SHAM tDCS in order to reduce subject expectancy bias.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

BIOPAC Stimsola

Intervention Type DEVICE

Transcranial Electrical Stimulator

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.

Group Type SHAM_COMPARATOR

BIOPAC Stimsola Sham (zero amps)

Intervention Type DEVICE

Transcranial Electrical Stimulator set to 0 amps

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BIOPAC Stimsola

Transcranial Electrical Stimulator

Intervention Type DEVICE

BIOPAC Stimsola Sham (zero amps)

Transcranial Electrical Stimulator set to 0 amps

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No