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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered at 1, 3, and 6 month post-stroke visits
Awards & highlights
TIPSCI Trial 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.Check my eligibility
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.See study design
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.
TIPSCI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult who had stroke symptoms start within the last week.
Select...
I can do most daily activities without help.
TIPSCI Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Cognition as assessed by our Cognitive Battery
Change in Functional Connectivity as assessed by MEG
TIPSCI 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).
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,262 Previous Clinical Trials
14,823,104 Total Patients Enrolled
33 Trials studying Stroke
28,862 Patients Enrolled for Stroke
University of Maryland, College ParkOTHER
155 Previous Clinical Trials
45,605 Total Patients Enrolled
5 Trials studying Stroke
254 Patients Enrolled for Stroke
Elisabeth B Marsh, MDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
85 Total Patients Enrolled
2 Trials studying Stroke
85 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have bleeding in your brain as shown by a head CT or MRI.I have hearing or vision problems that haven't been corrected.I have a major blood vessel blockage near my heart or brain.I don't have metal implants or devices that could interfere with brain scans.You have a fear of small spaces, are very overweight, or have any other reason that makes it hard for you to stay in the MEG machine for up to 1 hour.I cannot attend treatment or follow-up sessions.I cannot travel to College Park for MEG sessions.Your stroke severity score is less than 8 at your first follow-up visit, which is about 30 days after the stroke.You have shown signs of difficulty with speaking or paying attention during a medical examination.I have a history of dementia or untreated mental health issues.I am an adult who had stroke symptoms start within the last week.You have recently had a stroke shown on a brain MRI. Strokes that don't show up on imaging and transient ischemic attacks (TIAs) will also be excluded.I can do most daily activities without help.
Research Study Groups:
This trial has the following groups:- Group 1: A-tDCS
- Group 2: Sham Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are adults over the age of 20 eligible for participation in this clinical trial?
"As specified by the requirements of this trial, participants must be between 18 and 100 years old."
Answered by AI
Has the enrollment process for this clinical trial commenced yet?
"Affirmative. Data sourced from clinicaltrials.gov demonstrates that this medical trial is actively recruiting participants, having been first posted on September 1st 2022 and last edited a week later. The research team requires 60 patients to be recruited for the study at its sole location."
Answered by AI
Do I satisfy the criteria necessary to join this medical experiment?
"This medical trial seeks to enrol 60 participants who have suffered from a stroke and its aftermath, aged between 18 years old up to 100."
Answered by AI
What is the aggregate figure of participants involved in this clinical trial?
"Affirmative. Clinicaltrials.gov shows that this trial is actively enrolling volunteers, with its listing first created on September 1st 2022 and modified most recently on the 8th of the same month. The research requires 60 participants from a single site."
Answered by AI
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