Developing an EEG Probe for Studying and Modulating Cognitive Control

Study Overview
=================
Brief Summary
-----------------
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)

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.

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

Conditions
-----------------
Post-stroke Depression

Intervention / Treatment
-----------------
* Procedure: Transcranial Electrical stimulation
* Procedure: Transcutaneous direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will include both male and female of age over 18 years and a BMI of 18-35 Kg/mts2 who have experienced stroke. Moderately depressed, MADRS:18-28, PHQ9: 10-20 and/or experiencing cognitive impairments after stroke Exclusion Criteria: Current or lifetime bipolar disorder or schizophrenia diagnosis; current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed); significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year: current chronic severe pain conditions; 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); skin lesions on electrode placement region; implanted electrical medical devices; Pregnancy; suspected IQ<80, and 10) any other clinically relevant reason as judged by the clinician.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |