TDCS to Improve Post-Stroke Cognitive Impairment
TIPSCI
1 other identifier
interventional
60
1 country
1
Brief Summary
The investigators will conduct a randomized, double-blinded, sham-controlled trial of approximately 60 patients with minor stroke and post-stroke mild cognitive impairment (psMCI). Participants will be individually randomized on enrollment using a random number generator to treatment with anodal tDCS + computerized cognitive treatment (CCT) versus sham + CCT (approximately 30 patients in each arm). Clinical evaluation including assessment of cognition will be performed pre- and post-intervention by individuals on the study team blinded to the participant's intervention. Participants will also undergo functional neuroimaging with magnetoencephalography (MEG) pre- and post-intervention (1, 3, and 6 months post-stroke to evaluate for initial and longer-term effects of treatment on cerebral activation patterns and functional connectivity). Neuroimaging and clinical outcomes will be assessed to determine the effect of tDCS versus sham + CCT on psMCI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Sep 2022
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2022
CompletedFirst Posted
Study publicly available on registry
January 19, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
September 16, 2025
September 1, 2025
4 years
January 4, 2022
September 10, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Cognition as assessed by our Cognitive Battery
Our cognitive battery was designed to efficiently evaluate for psMCI. It combines the Montreal Cognitive Assessment, Grooved Pegboard, Hopkins Verbal Learning Test, Brief Visuospatial Memory Test, Delis-Kaplan Executive Function System, and Symbol Digit Modalities Test. T scores are averaged across tasks and calculated for the following cognitive domains: verbal memory, spatial memory, processing speed, motor speed, executive function, and global cognition.
Administered at 1, 3, and 6 month post-stroke visits
Change in Functional Connectivity as assessed by MEG
Participants will undergo an MEG evaluating global functional connectivity: 1) during resting state, and 2) during completion of a visual task. Connectivity will also be evaluated within the following specific cognitive networks: frontoparietal (executive) and limbic (memory)
Administered at 1, 3, and 6 month post-stroke visits
Study Arms (2)
A-tDCS
EXPERIMENTALParticipants 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).
Sham Intervention
ACTIVE COMPARATORParticipants 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).
Interventions
Participants randomized to tDCS will undergo 5 weeks of A-tDCS + CCT.
Participants randomized to sham-intervention will undergo 5 weeks of sham + CCT.
Eligibility Criteria
You may qualify if:
- Adults (≥18 years) presenting with neurological symptoms due to acute ischemic stroke (symptom onset within the week prior to admission).
- Evidence on brain MRI of acute ischemic stroke (imaging negative strokes and TIAs will be excluded).
- Native English speaker (by self-report) prior to stroke.
- NIHSS \<8 at initial follow-up visit (approximately 30 days post-stroke).
- mRS 0-2 at initial follow-up visit.
You may not qualify if:
- Primary intracerebral hemorrhage- as evidenced by blood on head CT or MRI.
- Presence of proximal large vessel occlusion.
- Cortical exam findings including aphasia or neglect.
- Prior report or history of dementia or undertreated psychiatric illness.
- Uncorrected hearing or visual loss.
- Inability to attend treatment or follow-up sessions.
- Inability to travel to College Park (UMD) for MEG recording sessions.
- 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).
- Claustrophobia, obesity, and/or any other reason leading to difficulty staying in the MEG machine for up to 1 hour.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- University of Maryland, College Parkcollaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Related Publications (3)
Marsh EB, Brodbeck C, Llinas RH, Mallick D, Kulasingham JP, Simon JZ, Llinas RR. Poststroke acute dysexecutive syndrome, a disorder resulting from minor stroke due to disruption of network dynamics. Proc Natl Acad Sci U S A. 2020 Dec 29;117(52):33578-33585. doi: 10.1073/pnas.2013231117. Epub 2020 Dec 14.
PMID: 33318200BACKGROUNDMarsh EB, Lawrence E, Hillis AE, Chen K, Gottesman RF, Llinas RH. Pre-stroke employment results in better patient-reported outcomes after minor stroke: Short title: Functional outcomes after minor stroke. Clin Neurol Neurosurg. 2018 Feb;165:38-42. doi: 10.1016/j.clineuro.2017.12.020. Epub 2017 Dec 27.
PMID: 29306185BACKGROUNDSharma R, Mallick D, Llinas RH, Marsh EB. Early Post-stroke Cognition: In-hospital Predictors and the Association With Functional Outcome. Front Neurol. 2020 Dec 23;11:613607. doi: 10.3389/fneur.2020.613607. eCollection 2020.
PMID: 33424761BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elisabeth B Marsh, MD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2022
First Posted
January 19, 2022
Study Start
September 1, 2022
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
September 16, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- One year following completion of data collection and publication of results.
Results in aggregate will be posted; however, de-identified individual participant data will be made available to other investigators and potential collaborators upon reasonable request of the PI.