tDCS for Post-Stroke Cognitive Impairment

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

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).

Study Overview

• Status: Recruiting
• Conditions: Stroke; Mild Cognitive Impairment
• Intervention / Treatment: Device: Transcranial Dirrect Current Stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cheryl Adams, RN; Phone Number: (405) 271-8130; Email: gerolab@ouhsc.edu
• Study Contact Backup: Name: Camila Bonin Pinto, PhD; Phone Number: (405) 271-8130; Email: gerolab@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • Recruiting
      • University of Oklahoma
      • Contact: Cheryl Adams, RN; Phone Number: 405-271-8130; Email: gerolab@ouhsc.edu
      • Principal Investigator: Camila Bonin Pinto, PhD
      • Sub-Investigator: Faddi Saleh Velez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sham tDCS; Participants will receive sham (placebo) tDCS for 20 minutes, for 10 sessions	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-orbital area.; Other Names: tDCS
Experimental: active tDCS; Participants will receive active tDCS for 20 minutes, for 10 sessions	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-orbital area.; Other Names: tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: American Heart Association

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Post-Stroke cognitive impairment
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Stroke; Cognitive Dysfunction
• Other Study ID Numbers: 17265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No