Developing an EEG Probe for Studying and Modulating Cognitive Control

NCT ID: NCT05612659

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-28
• Study Completion Date: 2024-05-30

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.

Conditions

Post-stroke Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Transcranial Electrical stimulation

Subjects will receive transcranial electrical stimulation.

Group Type: EXPERIMENTAL

Transcranial Electrical stimulation

Intervention Type: PROCEDURE

Noninvasive electrical stimulation of lateral frontal cortex.

Transcutaneous direct current stimulation

Subjects will receive Transcutaneous direct current stimulation

Group Type: EXPERIMENTAL

Transcutaneous direct current stimulation

Intervention Type: PROCEDURE

Noninvasive electrical stimulation of the T10 spinal column.

Interventions

Transcranial Electrical stimulation

Noninvasive electrical stimulation of lateral frontal cortex.

Intervention Type: PROCEDURE

Transcutaneous direct current stimulation

Noninvasive electrical stimulation of the T10 spinal column.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Ishita Basu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

EEG_noninvasive_stimulation

Identifier Type: -

Identifier Source: org_study_id