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

University of Cincinnati

Status: Completed

Conditions: Post-stroke Depression

Treatments: Procedure: Transcranial Electrical stimulation; Procedure: Transcutaneous direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05612659

EEG_noninvasive_stimulation

Details and patient eligibility

About

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)

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Transcranial Electrical stimulation

Experimental group

Description:

Subjects will receive transcranial electrical stimulation.

Treatment:

Procedure: Transcranial Electrical stimulation

Transcutaneous direct current stimulation

Experimental group

Description:

Subjects will receive Transcutaneous direct current stimulation

Treatment:

Procedure: Transcutaneous direct current stimulation