Recruiting
Phase 2

tDCS

Sponsor:

University of Oklahoma

Code:

NCT06516588

Conditions

Stroke

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial Dirrect Current Stimulation

Study Details

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

Study ID

NCT06516588

Start date

Sep 30, 2024

Status verified date

Oct, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: sham tDCS

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

experimental: active tDCS

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

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.

Primary outcome measure

  • Montreal Cognitive Assessment (MoCA) [ Time Frame: Changes from baseline after intervention week (two weeks), one and three months ]
  • NIH Toolbox [ Time Frame: Changes from baseline after one and three months ]

Central Contacts and Locations

Central contacts

Cheryl Adams, RN

(405) 271-8130gerolab@ouhsc.edu

Camila Bonin Pinto, PhD

(405) 271-8130gerolab@ouhsc.edu

Locations

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73117

Contacts

Cheryl Adams, RN

405-271-8130gerolab@ouhsc.edu

Principal Investigator:

Camila Bonin Pinto, PhD

More Information

Sponsor

University of Oklahoma

Last update posted

Oct 10, 2024

Last verified

Oct, 2024

Keywords

  • Post-Stroke cognitive impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2024-10-10.