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

June 25, 2024 updated by: Ishita Basu, University of Cincinnati

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

Intervention / Treatment

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

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

Study Locations

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

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

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

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

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

University of Cincinnati

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)

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

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

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