PSD: Developing an EEG Probe for Studying and Modulating Cognitive Control

• Sponsor: University of Cincinnati (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05612659
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 0.7

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Post-stroke Depression	Procedure: Transcranial Electrical stimulation; Procedure: Transcutaneous direct current stimulation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Sep 28, 2022
• Anticipated Primary Completion Date: Mar 31, 2024
• Anticipated Study Completion Date: May 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transcranial Electrical stimulation Subjects will receive transcranial electrical stimulation.	Procedure: Transcranial Electrical stimulation; Noninvasive electrical stimulation of lateral frontal cortex.
Experimental: Transcutaneous direct current stimulation Subjects will receive Transcutaneous direct current stimulation	Procedure: Transcutaneous direct current stimulation; Noninvasive electrical stimulation of the T10 spinal column.

Outcome Measures

Primary Outcome Measures

1. EEG oscillations [change from baseline]

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

Secondary Outcome Measures

1. Behavior [during procedure]

   Response time in a multi source interference task

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati	Cincinnati	Ohio	United States	45267

Sponsors and Collaborators

• University of Cincinnati

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ishita Basu, Associate Professor, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT05612659
• Other Study ID Numbers: EEG_noninvasive_stimulation
• First Posted: Nov 10, 2022
• Last Update Posted: Nov 10, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of Nov 10, 2022