Developing an EEG Probe for Studying and Modulating Cognitive Control
PSD
1 other identifier
interventional
30
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2022
CompletedFirst Submitted
Initial submission to the registry
October 31, 2022
CompletedFirst Posted
Study publicly available on registry
November 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedJune 27, 2024
June 1, 2024
1.5 years
October 31, 2022
June 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
EEG oscillations
Theta (4-8 Hz) oscillations in the mid frontal EEG
change from baseline
Secondary Outcomes (1)
Behavior
during procedure
Study Arms (2)
Transcranial Electrical stimulation
EXPERIMENTALSubjects will receive transcranial electrical stimulation.
Transcutaneous direct current stimulation
EXPERIMENTALSubjects will receive Transcutaneous direct current stimulation
Interventions
Noninvasive electrical stimulation of lateral frontal cortex.
Noninvasive electrical stimulation of the T10 spinal column.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cincinnati
Cincinnati, Ohio, 45267, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 31, 2022
First Posted
November 10, 2022
Study Start
September 28, 2022
Primary Completion
March 31, 2024
Study Completion
May 30, 2024
Last Updated
June 27, 2024
Record last verified: 2024-06