tDCS for Post-Stroke Cognitive Impairment

NCT06516588 | Recruiting Phase 2 FDA Device

• 1 other identifier: 17265
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke; Mild Cognitive Impairment

Keywords

Post-Stroke cognitive impairment

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Neurovascular Coupling - Cerebral blood flow (fNIRS)

  Changes on fNIRS signal from baseline after after intervention week (two weeks), one and three months

• Brain Function (EEG)

  Changes on EEG signal from baseline after after intervention week (two weeks), one and three months

• Neurovascular Coupling - (DVA)

  Changes on maximal arteriolar dilation and mean maximal venular dilation from baseline after intervention week (two weeks), one and three months

• Blood markers

  Changes on blood marker levels from baseline after intervention week (two weeks), one and three months

Study Arms (2)

sham tDCS

SHAM COMPARATOR

Participants will receive sham (placebo) tDCS for 20 minutes, for 10 sessions

Device: Transcranial Dirrect Current Stimulation

active tDCS

EXPERIMENTAL

Participants will receive active tDCS for 20 minutes, for 10 sessions

Device: Transcranial Dirrect Current Stimulation

Interventions

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.

Also known as: tDCS

active tDCS; sham tDCS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• American Heart Association: collaborator

Study Sites (1)

University of Oklahoma

Oklahoma City, Oklahoma, 73117, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Cheryl Adams, RN

CONTACT

(405) 271-8130; gerolab@ouhsc.edu

Camila Bonin Pinto, PhD

CONTACT

(405) 271-8130; gerolab@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 24, 2024
• Study Start: September 30, 2024
• Primary Completion: June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)