Developing an EEG Probe for Studying and Modulating Cognitive Control

Not Applicable

Completed

• Conditions: Post-stroke Depression
• Interventions: Procedure: Transcranial Electrical stimulation; Procedure: Transcutaneous direct current stimulation

• Registration Number: NCT05612659
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study Start: 2022-09-28
• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-10
• Primary Completion: 2024-03-31
• Study Completion: 2024-05-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transcranial Electrical stimulation	Transcranial Electrical stimulation	Subjects will receive transcranial electrical stimulation.
Transcutaneous direct current stimulation	Transcutaneous direct current stimulation	Subjects will receive Transcutaneous direct current stimulation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Behavior	during procedure	Response time in a multi source interference task

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States