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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sham tDCS | Sham Comparator | Participants will receive sham (placebo) tDCS for 20 minutes, for 10 sessions |
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| active tDCS | Experimental | Participants will receive active tDCS for 20 minutes, for 10 sessions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Dirrect Current Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | 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. | Changes from baseline after intervention week (two weeks), one and three months |
| NIH Toolbox | 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. | Changes from baseline after one and three months |
| Measure | Description | Time Frame |
|---|---|---|
| Neurovascular Coupling - Cerebral blood flow (fNIRS) | fNIRS signal will be recorded using the 16-source/16-detector system (NIRSport, NIRx) | Changes on fNIRS signal from baseline after after intervention week (two weeks), one and three months |
| Brain Function (EEG) |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheryl Adams, RN | Contact | (405) 271-8130 | gerolab@ouhsc.edu | |
| Camila Bonin Pinto, PhD | Contact | (405) 271-8130 | gerolab@ouhsc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma | Recruiting | Oklahoma City | Oklahoma | 73117 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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EEG signal will be recorded at 1 kHz using a 16-channel system (HIAMP,g.tec). |
| Changes on EEG signal from baseline after after intervention week (two weeks), one and three months |
| Neurovascular Coupling - (DVA) | DVA signal ill be recorded as the mean maximal arteriolar dilation and mean maximal venular dilation in response to flicker light stimulation. | Changes on maximal arteriolar dilation and mean maximal venular dilation from baseline after intervention week (two weeks), one and three months |
| Blood markers | 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. | Changes on blood marker levels from baseline after intervention week (two weeks), one and three months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |