Recruiting

tDCS & CCT

Sponsor:

Johns Hopkins University

Code:

NCT05195398

Conditions

Stroke

Stroke Sequelae

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Anodal transcranial Direct Current Stimulation (A-tDCS)

Sham Intervention

Study Details

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.

Conditions

Stroke

Stroke Sequelae

Cognitive Impairment

Study ID

NCT05195398

Start date

Sep 1, 2022

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults (≥18 years) presenting with neurological symptoms due to acute ischemic stroke (symptom onset within the week prior to admission).
2. Evidence on brain MRI of acute ischemic stroke (imaging negative strokes and TIAs will be excluded).
3. Native English speaker (by self-report) prior to stroke.
4. NIHSS <8 at initial follow-up visit (approximately 30 days post-stroke).
5. mRS 0-2 at initial follow-up visit.

Exclusion Criteria:

1. Primary intracerebral hemorrhage- as evidenced by blood on head CT or MRI.
2. Presence of proximal large vessel occlusion.
3. Cortical exam findings including aphasia or neglect.
4. Prior report or history of dementia or undertreated psychiatric illness.
5. Uncorrected hearing or visual loss.
6. Inability to attend treatment or follow-up sessions.
7. Inability to travel to College Park (UMD) for MEG recording sessions.
8. 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).
9. Claustrophobia, obesity, and/or any other reason leading to difficulty staying in the MEG machine for up to 1 hour.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Anodal transcranial Direct Current Stimulation (A-tDCS)

Participants randomized to tDCS will undergo 5 weeks of A-tDCS + CCT.

Sham Intervention

Participants randomized to sham-intervention will undergo 5 weeks of sham + 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 ]
  • Change in Functional Connectivity as assessed by MEG [ Time Frame: Administered at 1, 3, and 6 month post-stroke visits ]

Central Contacts and Locations

Central contacts

Elisabeth B Marsh, MD

410-550-8703ebmarsh@jhmi.edu

Locations

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Eliabeth B Marsh, MD

410-550-8703ebmarsh@jhmi.edu

Rafael H Llinas, MD

4105501042rllinas@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-08-10.