NCT07535788

Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Casa Colina Hospital and Centers for Healthcare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

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.

Conditions

• Aphasia
• Stroke

Interventions

Type	Name	Description
DEVICE	transcranial direct current stimulation (tDCS)	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)

Timeline

• Start date: 2026-05-04
• Primary completion: 2027-05-04
• Completion: 2027-05-30
• First posted: 2026-04-17
• Last updated: 2026-04-17

Regulatory

• FDA-regulated device study