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Non-invasive Brain Stimulation

tDCS + Cognitive Therapy for Stroke-related Cognitive Impairment (TRAINS Trial)

N/A

Recruiting

Led By Kelly Sloane, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Able to follow simple commands as evidenced by NIHSS subtest 1C =0

Between the ages of 18 and 90

Must not have

History of reoccurring seizures or epilepsy

History of chronic, serious, or unstable neurologic illness other than stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline assessment prior to intervention; immediate post-intervention; 12 weeks (+/- 4 weeks) post-intervention; 12 months (+/- 4 weeks) post-intervention

Summary

This trial will test whether adding electrical stimulation to cognitive therapy can improve thinking skills in people who have had a stroke.

Who is the study for?

This trial is for individuals aged 18-90 who've had a stroke within the last 4 weeks and are now experiencing cognitive issues because of it. They must understand the study, follow simple commands, and not have serious neurological conditions (other than stroke), seizures, substance abuse problems, severe psychiatric disorders, unstable medical illnesses or metallic objects in their head.

What is being tested?

The study tests if brain stimulation with tDCS alongside traditional cognitive therapy can help improve thinking skills after a recent stroke. Participants will receive either real tDCS or a sham (fake) treatment to compare outcomes.

What are the potential side effects?

tDCS may cause mild side effects like itching, tingling or discomfort at the electrode site on the scalp. Some people might feel tired or get a headache after treatment. Serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

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

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I can understand and follow simple instructions.

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I am between 18 and 90 years old.

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I have thinking or memory problems due to a stroke.

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I understand the study and can agree to participate.

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I had a stroke less than 4 weeks ago.

Exclusion Criteria

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

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I have a history of seizures or epilepsy.

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I have a serious or unstable neurological condition, but not a stroke.

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I do not have a severe mental health condition.

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I do not have any unstable illnesses right now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline assessment prior to intervention; immediate post-intervention; 12 weeks (+/- 4 weeks) post-intervention; 12 months (+/- 4 weeks) post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline assessment prior to intervention; immediate post-intervention; 12 weeks (+/- 4 weeks) post-intervention; 12 months (+/- 4 weeks) post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline assessment prior to intervention; immediate post-intervention; 12 weeks (+/- 4 weeks) post-intervention; 12 months (+/- 4 weeks) post-intervention 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 Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Transcranial Direct Current Stimulation (tDCS) + cognitive therapyActive Control2 Interventions

Participants will undergo 5 daily sessions of tDCS for 20 minutes using a montage in which an anode (2 mA) is placed over left dorsolateral prefrontal cortex and the cathode will be place on the right supraorbital area. Subjects will participate in cognitive therapy during stimulation.

Group II: Sham Transcranial Direct Current Stimulation (tDCS) + cognitive therapyPlacebo Group2 Interventions

Participants will undergo 5 daily sessions of sham tDCS for 20 minutes using a montage in which an anode (2 mA) is placed over left dorsolateral prefrontal cortex and the cathode will be place on the right supraorbital area. Subjects will participate in cognitive therapy during stimulation.

0 / 9Eligibility criteria met