Effects of Transcranial Direct Current Stimulation (tDCS) on Language

Effects of tDCS in Language Recovery and Reorganization in Chronic Aphasia

Patrocinadores

Patrocinador principal: Medical College of Wisconsin

Fuente Medical College of Wisconsin
Resumen breve

This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.

Descripción detallada

Aphasia is a disturbance of language, primarily caused by brain injury to the left cerebral hemisphere. Aphasia treatments include speech and language therapy and pharmacologic therapy, but several studies have found that these treatments are not completely effective for patients with aphasia, leaving them with residual deficits that significantly add to the cost of stroke-related care. Additionally, the amount and frequency of speech and language therapy delivered may have a critical effect on recovery. Therefore, there is a need for new treatments or adjuncts to existing treatments, such as brain stimulation interventions, that have the potential to show greater improvements in patients with aphasia. One such new approach for non-invasive brain stimulation is transcranial direct current stimulation (tDCS).

This study will examine the effects of tDCS during speech therapy to further examine which method or methods is best for patient recovery. Patients enrolled in the study will undergo language testing that covers a broad range of language functions. Functional Magnetic Resonance Imaging (fMRI) will be completed before and after speech therapy intervention arms to investigate the neural processes affected by tDCS and speech therapy.

Study design:

Patients will be randomly assigned to one of 4 groups in a double-blind, partial crossover design. Patients will receive one of two different speech therapy treatment interventions to focus on specific processing deficits. Participants will undergo neuropsychological evaluation assessment before receiving sham or anodal-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure before crossing over to either receive sham or anodal-tDCS (whichever they have not already received), within the same speech therapy arm. They will complete a final behavioral assessment at the completion of the treatment.

Estado general Active, not recruiting
Fecha de inicio December 1, 2019
Fecha de Terminación December 31, 2029
Fecha de finalización primaria December 31, 2029
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Language performance on Picture Naming and Reading Tasks Through the study completion, about 6 months
Resultado secundario
Medida Periodo de tiempo
fMRI Through the study completion, about 6 months
Inscripción 4
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Transcranial Direct Current Stimulation

Descripción: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes.

Tipo de intervención: Device

Nombre de intervención: Sham Transcranial Direct Current Stimulation

Descripción: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion for 10 to 30 seconds and then ramped down. In this way, the participants experience the same initial sensations (mild tingling) as the tDCS group.

Tipo de intervención: Behavioral

Nombre de intervención: Phonologic-Focused Speech Therapy

Descripción: Participants are asked to generate or choose from a list phonologic information about a target picture.

Otro nombre: Phonologic Component Analysis

Tipo de intervención: Behavioral

Nombre de intervención: Semantic-Focused Speech Therapy

Descripción: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.

Otro nombre: Semantic Feature Analysis

Elegibilidad

Criterios:

Inclusion Criteria:

- Patients with a language deficit from focal neurologic damage (e.g. stroke, tumor).

- Patients must be adults and have English-language fluency.

- Patients must be eligible to undergo MRI.

Exclusion Criteria:

- Advanced neurodegenerative disease (i.e. Stage 3 Alzheimer's disease) or neurologic disorder (e.g. idiopathic epilepsy, Parkinson's disease, ALS)

- Severe psychopathology (e.g. schizophrenia, bipolar disorder, acute major depressive episode)

- No suspected or diagnosed uncorrectable hearing or vision difficulties, or developmental disabilities (i.e. intellectual disability or learning disability).

- Contraindications to MRI such as claustrophobia, implanted electronic devices, MRI-incompatible metal in the body, extreme obesity, pregnancy, inability to lie flat, and inability to see or hear stimulus materials

Género: All

Edad mínima: 18 Years

Edad máxima: 85 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Sara Pillay, PhD Principal Investigator Medical College of Wisconsin
Ubicación
Instalaciones: Medical College of Wisconsin
Ubicacion Paises

United States

Fecha de verificación

June 2020

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Medical College of Wisconsin

Nombre completo del investigador: Sara Pillay

Título del investigador: Assistant Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 4
Grupo de brazo

Etiqueta: Active tDCS with Phonologic-Focused Speech Therapy

Tipo: Active Comparator

Descripción: Participants will receive phonologic-focused speech therapy with anodal-tDCS for 10 therapy sessions before.

Etiqueta: Sham tDCS with Phonologic-Focused Speech Therapy

Tipo: Sham Comparator

Descripción: Participants will receive phonologic-focused speech therapy with sham tDCS for 10 therapy sessions.

Etiqueta: Active tDCS with Semantic-Focused Speech Therapy

Tipo: Active Comparator

Descripción: Participants will receive semantic-focused speech therapy with anodal-tDCS for 10 therapy sessions.

Etiqueta: Sham tDCS with Semantic-Focused Speech Therapy

Tipo: Sham Comparator

Descripción: Participants will receive semantic-focused speech therapy with sham tDCS for 10 therapy sessions.

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Crossover Assignment

Descripción del modelo de intervención: Partial crossover design. Participants will maintain one of two speech therapy modalities throughout the study, but will crossover from active to sham stimulation (or vice versa).

Propósito primario: Treatment

Enmascaramiento: Triple (Participant, Care Provider, Investigator)

Descripción de enmascaramiento: Care provider, participant, and investigator are unmasked for speech therapy modality, but all are masked for tDCS sham or active status.

Fuente: ClinicalTrials.gov