tDCS for Post-Stroke Cognitive Impairment

University of Oklahoma (OU)

Status and phase: Enrolling; Phase 2

Conditions: Stroke; Mild Cognitive Impairment

Treatments: Device: Transcranial Dirrect Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06516588

17265

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

sham tDCS

Sham Comparator group

Description:

Participants will receive sham (placebo) tDCS for 20 minutes, for 10 sessions

Treatment:

Device: Transcranial Dirrect Current Stimulation

active tDCS

Experimental group

Description:

Participants will receive active tDCS for 20 minutes, for 10 sessions

Treatment:

Device: Transcranial Dirrect Current Stimulation