TDCS to Improve Post-Stroke Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Anodal transcranial Direct Current Stimulation (A-tDCS)
DeviceParticipants randomized to tDCS will undergo 5 weeks of A-tDCS + CCT.
Sham Intervention
DeviceParticipants randomized to sham-intervention will undergo 5 weeks of sham + CCT.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: A-tDCSExperimental treatment 1 intervention
Group B: Sham InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Administered at 1, 3, and 6 month post-stroke visits2
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)
Time frame
Administered at 1, 3, and 6 month post-stroke visitsSponsors and contacts
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Johns Hopkins University
Lead sponsor
University of Maryland, College Park
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov