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NCT Number: NCT06516588

tDCS for Post-Stroke Cognitive Impairment

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).

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Oklahoma

Oklahoma City, Oklahoma, 73117, United States

Location status: Recruiting

Location contact

Camila Bonin Pinto, PhD

PRINCIPAL_INVESTIGATOR

Cheryl Adams, RN

CONTACT

[email protected]

405-271-8130

Faddi Saleh Velez, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

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.

Other names: tDCS

Primary outcomes

  1. Montreal Cognitive Assessment (MoCA)

    Time frame: 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.

  2. NIH Toolbox

    Time frame: 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 outcomes

  1. Neurovascular Coupling - Cerebral blood flow (fNIRS)

    Time frame: 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)

  2. Brain Function (EEG)

    Time frame: 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).

  3. 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

    DVA signal ill be recorded as the mean maximal arteriolar dilation and mean maximal venular dilation in response to flicker light stimulation.

  4. Blood markers

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Camila Bonin Pinto, PhD

CONTACT

[email protected]

(405) 271-8130

Cheryl Adams, RN

CONTACT

[email protected]

(405) 271-8130

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 24, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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