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Предстои набиране NCT07535788

Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting

Заболявания: Aphasia Stroke

Спонсор: Casa Colina Hospital and Centers for Healthcare

Налично на: БГ
Обобщение
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)
Описание
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 implement
Кой може да участва
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
Интервенции
transcranial direct current stimulation (tDCS)
DEVICE
Места на провеждане

Информация за локации не е налична.

Технически детайли
Статус
Предстои набиране
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
04.05.2026
Крайна дата
30.05.2027
Регистрационен номер
NCT07535788
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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