NCT06516588

tDCS for Post-Stroke Cognitive Impairment

Post-Stroke Cognitive Impairment: Neurovascular Mechanisms and Non-Invasive Brain Stimulation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Mild Cognitive Impairment

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-30
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2024-07-24
• Last updated: 2024-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study