Back to resultsDeveloping an EEG Probe for Studying and Modulating Cognitive Control (PSD)
Primary Purpose
Post-stroke Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Electrical stimulation
Transcutaneous direct current stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Post-stroke Depression
Eligibility Criteria
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.
Sites / Locations
- University of CincinnatiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Transcranial Electrical stimulation
Transcutaneous direct current stimulation
Arm Description
Subjects will receive transcranial electrical stimulation.
Subjects will receive Transcutaneous direct current stimulation
Outcomes
Primary Outcome Measures
EEG oscillations
Theta (4-8 Hz) oscillations in the mid frontal EEG
Secondary Outcome Measures
Behavior
Response time in a multi source interference task
Full Information
NCT ID
NCT05612659
First Posted
October 31, 2022
Last Updated
November 4, 2022
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT05612659
Brief Title
Developing an EEG Probe for Studying and Modulating Cognitive Control
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Depression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcranial Electrical stimulation
Arm Type
Experimental
Arm Description
Subjects will receive transcranial electrical stimulation.
Arm Title
Transcutaneous direct current stimulation
Arm Type
Experimental
Arm Description
Subjects will receive Transcutaneous direct current stimulation
Intervention Type
Procedure
Intervention Name(s)
Transcranial Electrical stimulation
Intervention Description
Noninvasive electrical stimulation of lateral frontal cortex.
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous direct current stimulation
Intervention Description
Noninvasive electrical stimulation of the T10 spinal column.
Primary Outcome Measure Information:
Title
EEG oscillations
Description
Theta (4-8 Hz) oscillations in the mid frontal EEG
Time Frame
change from baseline
Secondary Outcome Measure Information:
Title
Behavior
Description
Response time in a multi source interference task
Time Frame
during procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ishita Basu, PhD
Phone
2178199493
Email
basuia@ucmail.uc.edu
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ishita Basu
Phone
217-819-9493
Email
basuia@ucmail.uc.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Developing an EEG Probe for Studying and Modulating Cognitive Control
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