TDCS to Improve Post-Stroke Cognitive Impairment

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
United States
Maryland
Johns Hopkins Bayview Medical Center
RECRUITING
Baltimore
Contact Information
Primary
Elisabeth B Marsh, MD
ebmarsh@jhmi.edu
410-550-8703
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 60
Treatments
Experimental: A-tDCS
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).
Active_comparator: Sham 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).
Related Therapeutic Areas
Sponsors
Collaborators: University of Maryland, College Park, National Institutes of Health (NIH)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov