Low Voltage Electrical Stimulation for Depression in Parkinson's Patients

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease; Depressive Symptoms
• Interventions: Device: BIOPAC Stimsola; Device: BIOPAC Stimsola Sham (zero amps)

• Registration Number: NCT06467695
• Lead Sponsor: University of South Alabama

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?

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 Timeline

• Study First Submitted: 2024-05-01
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21
• Study Start: 2024-08-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-09-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrical Stimulation (experimental)	BIOPAC Stimsola	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 Stimulation	BIOPAC Stimsola Sham (zero amps)	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.

Primary Outcome Measures

Name	Time	Method
Alpha band power pre-post change score	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.
Beck Depression Inventory (BDI) Pre-post change score	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.
RBANS Working Memory	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 Outcome Measures

Name	Time	Method
PDQ-39	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.