TDCS to Improve Post-Stroke Cognitive Impairment

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05195398
Status
Recruiting
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Conditions

  • Cognitive Impairment
  • Stroke
  • Stroke Sequelae

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Anodal transcranial Direct Current Stimulation (A-tDCS) — DEVICE
    Participants randomized to tDCS will undergo 5 weeks of A-tDCS + CCT.
  • Sham Intervention — DEVICE
    Participants randomized to sham-intervention will undergo 5 weeks of sham + CCT.

Study Details

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.

Key Dates

Start date
Sep 1, 2022
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Change in Cognition as assessed by our Cognitive Battery [ Time Frame: Administered at 1, 3, and 6 month post-stroke visits ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224
Eliabeth B Marsh, MD
[email protected]
410-550-8703
Rafael H Llinas, MD
[email protected]
4105501042

Find similar trials in Baltimore, MD

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Johns Hopkins Bayview Medical Center· Baltimore, MD

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