tDCS for Post-Stroke Cognitive Impairment

Phase 2

Recruiting

• Conditions: Stroke; Mild Cognitive Impairment
• Interventions: Device: Transcranial Dirrect Current Stimulation

• Registration Number: NCT06516588
• Lead Sponsor: University of Oklahoma

Brief Summary

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).

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.

Study Timeline

• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-24
• Study Start: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham tDCS	Transcranial Dirrect Current Stimulation	Participants will receive sham (placebo) tDCS for 20 minutes, for 10 sessions
active tDCS	Transcranial Dirrect Current Stimulation	Participants will receive active tDCS for 20 minutes, for 10 sessions

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA)	Changes from baseline after intervention week (two weeks), one and three months	It is a 30-point test about several cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) and a screening tool used of MCI and dementia.
NIH Toolbox	Changes from baseline after one and three months	NIH Toolbox tests is a computarize test that acess fluid abilities (i.e., working memory, processing speed, episodic memory, and two aspects of executive functioning) and crystallized abilities (i.e., dependent upon past learning and experience), resulting in Standard Scores for these superordinate categories, as well as a total Composite score of all tests.These norms were previously reported to align with the age-corrected normative data for the traditional neuropsychological measures.

Secondary Outcome Measures

Name	Time	Method
Neurovascular Coupling - Cerebral blood flow (fNIRS)	Changes on fNIRS signal from baseline after after intervention week (two weeks), one and three months	fNIRS signal will be recorded using the 16-source/16-detector system (NIRSport, NIRx)
Brain Function (EEG)	Changes on EEG signal from baseline after after intervention week (two weeks), one and three months	EEG signal will be recorded at 1 kHz using a 16-channel system (HIAMP,g.tec).
Neurovascular Coupling - (DVA)	Changes on maximal arteriolar dilation and mean maximal venular dilation from baseline after intervention week (two weeks), one and three months	DVA signal ill be recorded as the mean maximal arteriolar dilation and mean maximal venular dilation in response to flicker light stimulation.
Blood markers	Changes on blood marker levels from baseline after intervention week (two weeks), one and three months	Bblood draw via venipuncture and collect up to 40mL of blood for each visit. We will separate set of plasma (for study 4), serum samples, whole blood, and blood cells (including white blood cells) , a set of each will be stored for future analyses.

Trial Locations

Locations (1)

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States