Developing an EEG Probe for Studying and Modulating Cognitive Control (PSD)

Developing an EEG Probe for Studying Effects of Non-invasive Cortical and Spinal Cord Electrical Stimulation on Cognitive Control in Post Stroke Depression

This study aims to investigate effects of transcranial current stimulation (tES) and transcutaneous direct current stimulation (tsDCS) associated changes on fronto-parietal EEG and cognitive performance in patients with post stroke depression (PSD)

Study Overview

• Status: Completed
• Conditions: Post-stroke Depression
• Intervention / Treatment: Procedure: Transcranial Electrical stimulation; Procedure: Transcutaneous direct current stimulation

Detailed Description

The investigators will perform a double blind, randomized, sham controlled, crossover study design to assess effects of tES, tsDCS and sham stimulation on the performance during a cognitive control task. The working Hypothesis is tsDCS and/or tES will enhance frontal theta oscillations as recorded on EEGs and improve task performance compared to sham stimulation.

Results from this project can potentially lead to the development of a new research tool for assessing neuromodulation strategies to treat mental disorders and their comorbidities. It will also uncover the neural correlates of cognitive deficits in PSD and provide feasible biomarkers associated with treatment response in support of a larger clinical.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subjects will include both male and female of age over 18 years and a BMI of 18-35 Kg/mts2 who have experienced stroke.
2. Moderately depressed, MADRS:18-28, PHQ9: 10-20 and/or experiencing cognitive impairments after stroke

Exclusion Criteria:

1. Current or lifetime bipolar disorder or schizophrenia diagnosis;
2. current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed);
3. significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year:
4. current chronic severe pain conditions;
5. current chronic use of: opioids analgesics, medications that affect blood pressure or drugs with significant autonomic effects (stimulants and antipsychotics allowed if dose stable for 1 month);
6. skin lesions on electrode placement region;
7. implanted electrical medical devices;
8. Pregnancy;
9. suspected IQ<80, and 10) any other clinically relevant reason as judged by the clinician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial Electrical stimulation; Subjects will receive transcranial electrical stimulation.	Procedure: Transcranial Electrical stimulation; Noninvasive electrical stimulation of lateral frontal cortex.
Experimental: Transcutaneous direct current stimulation; Subjects will receive Transcutaneous direct current stimulation	Procedure: Transcutaneous direct current stimulation; Noninvasive electrical stimulation of the T10 spinal column.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG oscillations	Theta (4-8 Hz) oscillations in the mid frontal EEG	change from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior	Response time in a multi source interference task	during procedure

Collaborators and Investigators

• Sponsor: University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: EEG_noninvasive_stimulation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No