Using brain stimulation to improve cognitive function after a stroke

TDCS to Improve Post-Stroke Cognitive Impairment

This study is testing if a type of brain stimulation combined with computer exercises can help people who have had a minor stroke and are struggling with thinking skills.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Johns Hopkins University (other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT05195398 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of anodal transcranial Direct Current Stimulation (A-tDCS) combined with computerized cognitive treatment (CCT) on patients who have experienced a minor stroke and are suffering from post-stroke mild cognitive impairment (psMCI). Approximately 60 participants will be randomly assigned to receive either the active treatment or a sham intervention, with their cognitive function assessed before and after the intervention. Additionally, functional neuroimaging using magnetoencephalography (MEG) will be conducted to evaluate changes in brain activity and connectivity over time. The goal is to determine whether A-tDCS can enhance cognitive recovery in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced a minor ischemic stroke within the past week and exhibit mild cognitive impairment.

Not a fit: Patients with primary intracerebral hemorrhage, significant psychiatric illness, or those unable to participate in follow-up sessions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve cognitive function and quality of life for stroke survivors experiencing cognitive impairment.

How similar studies have performed: While the use of tDCS in cognitive rehabilitation is being explored, this specific application in post-stroke cognitive impairment is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Adults (≥18 years) presenting with neurological symptoms due to acute ischemic stroke (symptom onset within the week prior to admission).
2. Evidence on brain MRI of acute ischemic stroke (imaging negative strokes and TIAs will be excluded).
3. Native English speaker (by self-report) prior to stroke.
4. NIHSS \<8 at initial follow-up visit (approximately 30 days post-stroke).
5. mRS 0-2 at initial follow-up visit.

Exclusion Criteria:

1. Primary intracerebral hemorrhage- as evidenced by blood on head CT or MRI.
2. Presence of proximal large vessel occlusion.
3. Cortical exam findings including aphasia or neglect.
4. Prior report or history of dementia or undertreated psychiatric illness.
5. Uncorrected hearing or visual loss.
6. Inability to attend treatment or follow-up sessions.
7. Inability to travel to College Park (UMD) for MEG recording sessions.
8. Presence of any of the following that would lead to significant artifact on MEG: cardiac pacemaker, intracranial clips, metal implants or external clips within 10mm of the head, metal implants in the eyes (unlikely given that all patients will have an MRI and criteria are similar).
9. Claustrophobia, obesity, and/or any other reason leading to difficulty staying in the MEG machine for up to 1 hour.

Where this trial is running

Baltimore, Maryland

• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Elisabeth B Marsh, MD — Johns Hopkins University
• Study coordinator: Elisabeth B Marsh, MD

Conditions: Stroke, Stroke Sequelae, Cognitive Impairment