tDCS for Post-Stroke Cognitive Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Dirrect Current Stimulation.
- Who it may be relevant to
- Registry conditions: Stroke, Mild Cognitive Impairment. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-Stroke Cognitive Impairment: Neurovascular Mechanisms and Non-Invasive Brain Stimulation
Overview
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.
Interventions
- 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-orbit
Primary outcome measures
- Montreal Cognitive Assessment (MoCA) [Time frame: Changes from baseline after intervention week (two weeks), one and three months]
- NIH Toolbox [Time frame: Changes from baseline after one and three months]
Secondary outcome measures (4)
- Neurovascular Coupling - Cerebral blood flow (fNIRS) [Time frame: Changes on fNIRS signal from baseline after after intervention week (two weeks), one and three months]
- Brain Function (EEG) [Time frame: Changes on EEG signal from baseline after after intervention week (two weeks), one and three months]
- Neurovascular Coupling - (DVA) [Time frame: Changes on maximal arteriolar dilation and mean maximal venular dilation from baseline after intervention week (two weeks), one and three months]
- Blood markers [Time frame: Changes on blood marker levels from baseline after intervention week (two weeks), one and three months]
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
- clinically significant or unstable medical or psychiatric condition;
- diagnosis of severe depression;
- history of relevant neurological diagnosis (e.g., epilepsy);
- previous neurosurgical procedure with craniectomy;
- contraindications to tDCS (implanted brain medical devices);
- severe visual impairment, hearing impairment, aphasia, neglect or dementia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Oklahoma — Oklahoma City
Identifiers
NCT: NCT06516588 · 17265