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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

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

Awards & highlights

TRAINS Trial 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.Check my eligibility

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.See study design

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.

TRAINS Trial 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.

TRAINS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

TRAINS 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 / 5Eligibility criteria met

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,002 Previous Clinical Trials

42,880,929 Total Patients Enrolled

5 Trials studying Ischemic Stroke

290 Patients Enrolled for Ischemic Stroke

Kelly Sloane, MDPrincipal InvestigatorUniversity of Pennsylvania

Roy Hamilton, MDPrincipal InvestigatorUniversity of Pennsylvania

Media Library

tDCS (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04897334 — N/A

Ischemic Stroke Research Study Groups: Transcranial Direct Current Stimulation (tDCS) + cognitive therapy, Sham Transcranial Direct Current Stimulation (tDCS) + cognitive therapy

Ischemic Stroke Clinical Trial 2023: tDCS Highlights & Side Effects. Trial Name: NCT04897334 — N/A

tDCS (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04897334 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project actively seeking out participants aged 50 and above?

"This medical trial is looking for individuals aged 18 or over, but under 90 years of age."

Answered by AI

Does this medical study still have open enrollment?

"Indeed, the data on clinicaltrials.gov verifies that this medical research is recruiting patients at present. The trial was initially launched on September 21st 2021 and most recently amended on September 30th 2022. 96 volunteers need to be enrolled from 1 site in total."

Answered by AI

Could I potentially qualify for this research initiative?

"The research team is inviting 96 people who have experienced wake-up stroke to join the trial. All participants must meet a specified age range, spanning from 18 years old up to 90 years of age."

Answered by AI

What is the upper limit for enrollment in this experiment?

"Affirmative. The clinical trial portal,clinicaltrials.gov, states that this medical research is currently recruiting for its study - which was initially posted on the 21st of September 2021 and last modified on 30th of September 2022 - with a target sample size of 96 patients from one single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke

Kelly Sloane, MD 2021. "Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04897334.

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