tDCS for Post-Stroke Cognitive Impairment

Purpose

This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in participants with post-stroke cognitive impairment (PSCI).

Conditions

  • Stroke
  • Mild Cognitive Impairment

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. ) ischemic stroke participants in sub-acute phase (at least 10 days after stroke event or discharge and under 5 months post-event) with cognitive dysfunction (MoCA <26);

Exclusion Criteria

  1. clinically significant or unstable medical or psychiatric condition; 2. diagnosis of severe depression; 3. history of relevant neurological diagnosis (e.g., epilepsy); 4. previous neurosurgical procedure with craniectomy; 5. contraindications to tDCS (implanted brain medical devices); 6. severe visual impairment, hearing impairment, aphasia, neglect or dementia.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Sham Comparator
sham tDCS 		Participants will receive sham (placebo) tDCS for 20 minutes, for 10 sessions
  • Device: Transcranial Dirrect Current Stimulation
    tDCS will deliver direct current through rubber electrodes in saline-soaked sponges. Device sends a low-level current from the positive electrode, the anode, to the negative electrode, the cathode. Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35cm2) and delivered by a specially developed, battery-driven, constant current stimulator with a maximum output of 10mA. The anode will be placed over the LDLPFC and the cathode over the contralateral supra-orbital area.
    Other names:
    • tDCS
Experimental
active tDCS 		Participants will receive active tDCS for 20 minutes, for 10 sessions
  • Device: Transcranial Dirrect Current Stimulation
    tDCS will deliver direct current through rubber electrodes in saline-soaked sponges. Device sends a low-level current from the positive electrode, the anode, to the negative electrode, the cathode. Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35cm2) and delivered by a specially developed, battery-driven, constant current stimulator with a maximum output of 10mA. The anode will be placed over the LDLPFC and the cathode over the contralateral supra-orbital area.
    Other names:
    • tDCS

Recruiting Locations

University of Oklahoma
Oklahoma City, Oklahoma 73117
Contact:
Cheryl Adams, RN
405-271-8130
gerolab@ouhsc.edu

More Details

Status
Recruiting
Sponsor
University of Oklahoma

Study Contact

Cheryl Adams, RN
(405) 271-8130
gerolab@ouhsc.edu

Detailed Description

The goal of this study is to learn important information about the effects of electrical stimulation (Transcranial direct current stimulation (tDCS) on brain functioning in those with post-stroke cognitive impairment (PSCI). The findings will help determine how stimulation affects the brain's activity, cerebral blood flow, and circulating blood biomarkers of neuroinflammation after stroke. The study will use different forms of non-invasive brain imaging to see whether stimulation changes how the brain responds during a memory task. Functional near-infrared spectroscopy (fNIRS) and electroencephalograph (EEG) will be used, we will also collect blood samples for the biomarkers of inflammation. The study also uses cognitive tests and questionnaires.