NCT07535788

Brief Summary

This study looks at whether transcranial Direct Current Stimulation (tDCS) can be effectively implemented in inpatient and outpatient rehabilitation settings during routine speech therapy for people who recently had a stroke and now have aphasia (difficulty speaking or understanding language)

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
13mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026May 2027

First Submitted

Initial submission to the registry

April 1, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

May 4, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2027

Expected
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 1, 2026

Last Update Submit

April 15, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Nasa Taskload Index (NTI)

    The NASA Task Load Index (NTI) is a widely used tool for measuring how demanding a task feels to a person. It captures subjective workload, meaning it asks individuals to rate how challenging a task was for them. It was developed by NASA researchers in the 1980s to better understand how mental and physical demands affect performance

    3 months, 6 months and 1 year (after the start of data collection, approximately)

  • Theoretical Domain Framework (TDF) questionnaire

    The Theoretical Domains Framework (TDF) is a structured approach used to understand why people do or do not change behavior in healthcare and other settings. It brings together key concepts from multiple behavior-change theories into a single framework to help identify barriers and facilitators to implementing new practices.

    at baseline, as well as 3 months, 6 months and 1 year (after the start of data collection, approximately)

Secondary Outcomes (1)

  • Western Aphasia Battery Revised (WABr)

    at patient's admission and discharge (around 3 weeks after admission)

Other Outcomes (1)

  • Adverse Event Questionnaire (AEQ)

    3 months and 6 months (after the start of data collection, approximately)

Interventions

20 minute anodal tDCS (1mA) to the left inferior frontal (Broca) area, concurrent with speech and language therapy by a trained speech language pathologist (SLP) over their stay (during at least 5 sessions)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult stroke patients with aphasia of inpatient and outpatient settings of Casa Colina Hospital and Centers for Healthcare

You may qualify if:

  • ischemic or hemorrhagic stroke
  • aphasia

You may not qualify if:

  • not a patient at either inpatient and outpatient settings of Casa Colina Hospital and Centers for Healthcare

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Williams EER, Sghirripa S, Rogasch NC, Hordacre B, Attrill S. Non-invasive brain stimulation in the treatment of post-stroke aphasia: a scoping review. Disabil Rehabil. 2024 Aug;46(17):3802-3826. doi: 10.1080/09638288.2023.2259299. Epub 2023 Oct 13.

    PMID: 37828899BACKGROUND
  • Picano C, Quadrini A, Pisano F, Marangolo P. Adjunctive Approaches to Aphasia Rehabilitation: A Review on Efficacy and Safety. Brain Sci. 2021 Jan 2;11(1):41. doi: 10.3390/brainsci11010041.

    PMID: 33401678BACKGROUND
  • Breining BL, Sebastian R. Neuromodulation in post-stroke aphasia treatment. Curr Phys Med Rehabil Rep. 2020 Jun;8(2):44-56. doi: 10.1007/s40141-020-00257-5. Epub 2020 Feb 22.

    PMID: 33344066BACKGROUND
  • Khan A, Yuan K, Bao SC, Ti CHE, Tariq A, Anjum N, Tong RK. Can Transcranial Electrical Stimulation Facilitate Post-stroke Cognitive Rehabilitation? A Systematic Review and Meta-Analysis. Front Rehabil Sci. 2022 Feb 10;3:795737. doi: 10.3389/fresc.2022.795737. eCollection 2022.

    PMID: 36188889BACKGROUND

MeSH Terms

Conditions

AphasiaStroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Caroline Schnakers, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Research

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 17, 2026

Study Start

May 4, 2026

Primary Completion (Estimated)

May 4, 2027

Study Completion (Estimated)

May 30, 2027

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Data will be collected as part of routine clinical care and implementation activities, and participants will not provide consent for public data sharing. Data access is therefore restricted to protect participant privacy and confidentiality, in accordance with institutional policies and ethical guidelines.