tDCS for Post-Stroke Cognitive Impairment

NCT ID: NCT06516588

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-06-30

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).

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.

Conditions

Stroke; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

sham tDCS

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

Group Type: SHAM_COMPARATOR

Transcranial Dirrect Current Stimulation

Intervention Type: 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.

active tDCS

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

Group Type: EXPERIMENTAL

Transcranial Dirrect Current Stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

tDCS

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cheryl Adams, RN

Role: CONTACT

gerolab@ouhsc.edu

(405) 271-8130

Camila Bonin Pinto, PhD

Role: CONTACT

gerolab@ouhsc.edu

(405) 271-8130

Facility Contacts

Cheryl Adams, RN

Role: primary

gerolab@ouhsc.edu

405-271-8130

Other Identifiers

17265

Identifier Type: -

Identifier Source: org_study_id