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Behavioural Intervention

tDCS + Cognitive Training for Post-Stroke Cognitive Impairment (TIPSCI Trial)

N/A

Recruiting

Led By Elisabeth B Marsh, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (≥18 years) presenting with neurological symptoms due to acute ischemic stroke (symptom onset within the week prior to admission)

mRS 0-2 at initial follow-up visit

Must not have

Uncorrected hearing or visual loss

Presence of proximal large vessel occlusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up administered at 1, 3, and 6 month post-stroke visits

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a computerized cognitive treatment combined with a brain stimulation technique called transcranial direct current stimulation (tDCS) can improve cognition in people who have had a minor stroke. The trial will compare the effect of the tDCS + CCT to sham + CCT (where the sham is a fake tDCS that does not actually stimulate the brain). Clinical evaluations and brain imaging will be performed before and after the intervention to assess the effect of tDCS + CCT on post-stroke mild cognitive impairment.

Who is the study for?

This trial is for adults over 18 who've had a minor stroke within the last week and show mild cognitive issues afterward. They must speak English, have manageable stroke symptoms (NIHSS <8), and be relatively independent (mRS 0-2). People with dementia, severe psychiatric illness, or those unable to attend sessions are excluded.

What is being tested?

The study tests if anodal transcranial Direct Current Stimulation (A-tDCS) combined with computerized cognitive treatment improves cognition in post-stroke patients compared to a sham intervention. It's randomized and double-blinded, meaning participants won't know which treatment they're getting.

What are the potential side effects?

Potential side effects of A-tDCS may include discomfort at the electrode site, itching or tingling during stimulation, fatigue, headache, nausea or insomnia. However, these are typically mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult who had stroke symptoms start within the last week.

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I can do most daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have hearing or vision problems that haven't been corrected.

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I have a major blood vessel blockage near my heart or brain.

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I cannot attend treatment or follow-up sessions.

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I have a history of dementia or untreated mental health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ administered at 1, 3, and 6 month post-stroke visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~administered at 1, 3, and 6 month post-stroke visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at 1, 3, and 6 month post-stroke visits for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Cognition as assessed by our Cognitive Battery

Change in Functional Connectivity as assessed by MEG

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: A-tDCSExperimental Treatment1 Intervention

Participants randomized to tDCS will undergo 15- 30 minute sessions over 5 weeks of A-tDCS to the ipsilesional frontoparietal cortex while participating in computerized cognitive therapy (CCT).

Group II: Sham InterventionActive Control1 Intervention

Participants randomized to sham will undergo 15- 30 minute sessions over 5 weeks of a sham-intervention, also applied to the ipsilesional frontoparietal cortex, while participating in computerized cognitive therapy (CCT).

0 / 6Eligibility criteria met