Developing an EEG Probe for Studying and Modulating Cognitive Control

Post-stroke Depression Clinical Trial

— PSD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05612659
• Other study ID #: EEG_noninvasive_stimulation
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2022
• Est. completion date: May 30, 2024

Study information

• Verified date: November 2023
• Source: University of Cincinnati
• Contact: Ishita Basu, PhD
• Phone: 2178199493
• Email: basuia[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Post-stroke Depression

Intervention

Procedure:
• Transcranial Electrical stimulation
Noninvasive electrical stimulation of lateral frontal cortex.
• Transcutaneous direct current stimulation
Noninvasive electrical stimulation of the T10 spinal column.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG oscillations	Theta (4-8 Hz) oscillations in the mid frontal EEG	change from baseline
Secondary	Behavior	Response time in a multi source interference task	during procedure