Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting (tDCS implement)

Implementing Transcranial Direct Current Stimulation (tDCS) in an Acute Rehabilitation Setting

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Aphasia
• Intervention / Treatment: Device: transcranial direct current stimulation (tDCS)

Detailed Description

Aphasia affects many stroke survivors and can impact communication, independence, and quality of life. Speech therapy helps, but recovery can be slow. Earlier research in people with long-term aphasia shows that adding gentle brain stimulation (tDCS) can improve both speech and comprehension when paired with language therapy. This study will explore how well tDCS can be integrated into everyday care for patients who are still early in their recovery.

Before starting the study, identified Speech-Language Pathologist (SLP) will be trained for the use of tDCS (BrainDriver v2.1 device, that has already been approved by Casa Colina Infection Control). The following workflow will be used for tDCS implementation with the SLP team: 1) Upon speech assessment, the SLP team will determine if an adult stroke patient meets criteria for aphasia, 2) Within 3 days, communication order will be obtained from physician for tDCS, 3) The tDCS equipment will be reserved for each session, 4) Equipment to be maintained in a locked cabinet, 4) tDCS equipment will be cleaned after each use, 5) patient label will be affixed on plastic bag holding sponges and placed in folder located in a locked cabinet, 6) tDCS treatment document will be filled on daily notes.

Patients will receive a 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). Since this is a feasibility study where the goal is to identify usability issues, workflow integration, and initial reactions. We will involve 5 SLP staff members who will use the device in around 30patients (6 patients/therapist).

This prospective implementation study will use a RE-AIM framework which has been previously used to implement medical devices in clinical settings. This framework includes 5 domains of assessment:

• REACH: The absolute number, proportion, and representativeness of individuals who are selected to participate in this study (eg, comparing participants to non-participants). These information will be collected in the hospital database.
• EFFECTIVENESS/EFFICACY: The impact of an intervention on important individual outcomes, including potential negative effects; and variability across subgroups (generalizability or heterogeneity of effects). Effectiveness will be assessed using the Western Aphasia Battery Revised (WABr) and the Adverse Event Questionnaire (AEQ). The WABr is a part of the clinical routine and data will be extracted from the hospital database. The AEQ will be added in a log.
• IMPLEMENTATION: At the setting level, implementation refers to the intervention agents' fidelity to the various elements of an intervention's key functions or components, including consistency of delivery as intended and the time and cost of the intervention. Importantly, it also includes adaptations made to interventions and implementation strategies. Consistency of implementation will be collected using a log. Barriers and facilitators will also be identified based on a tailored Theoretical Domain Framework (TDF) questionnaire. Cost of intervention in terms of time and money will be assessed using the Nasa Taskload Index (NTI) and Cost Effective Analysis (CEA), respectively.
• ADOPTION: The absolute number, proportion, and representativeness of intervention agents (staff who deliver the program) who are willing to initiate a program, and why. Data will be extracted post-study based on who participated.
• MAINTENANCE: At the setting level, the extent to which a program or policy becomes institutionalized or part of the routine organizational practices and policies. This aspect will be assessed with the implementation in 2 settings (inpatient and outpatient) with follow-up interviews at 6 months.

The staff will be interviewed using the NTI and a tailored TDF questionnaire (30 minutes). All the data related to adverse events (AEQ) and consistency of delivery will be collected in a log that the therapist will use during each session. All other information will be extracted from the hospital database. All the data will be collected at 3 timepoints (every 3 patients; 3patients/therapist). An additional timepoint at baseline will be added only for the TDF questionnaire. Descriptive analyses (proportion, frequency, percentage) will be used to analyze the results to our survey. Qualitative analyses will also be used for addressing the open-ended questions of our survey.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Caroline Schnakers, PhD; Phone Number: 3038 3108061443; Email: cschnakers@casacolina.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• ischemic or hemorrhagic stroke
• aphasia

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Aphasia Battery Revised (WABr)	The Western Aphasia Battery-Revised (WAB-R) is a standardized assessment used to identify the presence, type, and severity of aphasia in adults with acquired brain injury, most commonly stroke. It evaluates multiple language skills, including speech production, comprehension, repetition, and naming, as well as reading and writing.	at patient's admission and discharge (around 3 weeks after admission)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Questionnaire (AEQ)	The Adverse Event Questionnaire (AEQ) is a safety monitoring tool used to systematically record any unwanted or unexpected symptoms that occur during or after an intervention. It typically asks participants or clinicians to report the type, severity, timing, and duration of potential side effects. In this study, the AEQ is used to report known, low-risk side effects of tDCS, such as scalp tingling, skin irritation, headache, or fatigue.	3 months and 6 months (after the start of data collection, approximately)

Collaborators and Investigators

• Sponsor: Casa Colina Hospital and Centers for Healthcare

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 4, 2026
• Primary Completion (Estimated): May 4, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Speech Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Aphasia; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: IRB#23721124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No