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Developing an EEG Probe for Studying and Modulating Cognitive Control

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05612659
Acronym
PSD
Enrollment
30
Registered
2022-11-10
Start date
2022-09-28
Completion date
2024-05-30
Last updated
2024-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke Depression

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.

Interventions

PROCEDURETranscranial Electrical stimulation

Noninvasive electrical stimulation of lateral frontal cortex.

PROCEDURETranscutaneous direct current stimulation

Noninvasive electrical stimulation of the T10 spinal column.

Sponsors

University of Cincinnati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
EEG oscillationschange from baselineTheta (4-8 Hz) oscillations in the mid frontal EEG

Secondary

MeasureTime frameDescription
Behaviorduring procedureResponse time in a multi source interference task

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026