RECRUITING

TDCS to Improve Post-Stroke Cognitive Impairment

Conditions

Stroke Stroke Sequelae Cognitive Impairment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

TDCS to Improve Post-Stroke Cognitive Impairment

Quick Facts

Study Start:2022-09-01

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05195398

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Elisabeth B Marsh, MD

CONTACT

410-550-8703

ebmarsh@jhmi.edu

Principal Investigator

Elisabeth B Marsh, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Elisabeth B Marsh, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-01

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2022-09-01

Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

Stroke
Stroke Sequelae
Cognitive Impairment