Clinical trial NCT06516588: tDCS for Post-Stroke Cognitive Impairment
Official title: Post-Stroke Cognitive Impairment: Neurovascular Mechanisms and Non-Invasive Brain Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stroke
Mild Cognitive Impairment
Keywords: Post-Stroke cognitive impairment
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2024-07-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Changes from baseline after intervention week (two weeks), one and three months
measure: NIH Toolbox
timeFrame: Changes from baseline after one and three months
Secondary outcomes:
measure: Neurovascular Coupling - Cerebral blood flow (fNIRS)
timeFrame: Changes on fNIRS signal from baseline after after intervention week (two weeks), one and three months
measure: Brain Function (EEG)
timeFrame: Changes on EEG signal from baseline after after intervention week (two weeks), one and three months
measure: Neurovascular Coupling - (DVA)
timeFrame: Changes on maximal arteriolar dilation and mean maximal venular dilation from baseline after intervention week (two weeks), one and three months
measure: Blood markers
timeFrame: Changes on blood marker levels from baseline after intervention week (two weeks), one and three months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
Study officials:
References: