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OpenTrials
Completed

NCT Number: NCT05612659

Developing an EEG Probe for Studying and Modulating Cognitive Control

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)

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Electrical stimulation

Procedure

Noninvasive electrical stimulation of lateral frontal cortex.

Transcutaneous direct current stimulation

Procedure

Noninvasive electrical stimulation of the T10 spinal column.

Primary outcomes

  1. EEG oscillations

    Time frame: change from baseline

    Theta (4-8 Hz) oscillations in the mid frontal EEG

Secondary outcomes

  1. Behavior

    Time frame: during procedure

    Response time in a multi source interference task

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

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

Acronym: PSD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 10, 2022
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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