Using Non-invasive Brain Stimulation to Treat Word Finding Difficulty in Chronic Traumatic Brain Injury
Traumatic Brain Injury · Word Finding Difficulty · Cognitive Symptom · Cognitive Change · Acquired Brain Injury
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 85 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 14 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The purpose of this study is to learn more about how brain stimulation affects word finding problems in people who have a traumatic brain injury (TBI). The type of brain stimulation used is called transcranial direct current stimulation (tDCS). tDCS delivers low levels of electric current to the brain and high definition tDCS (HD-tDCS) delivers the current with multiple electrodes on the scalp. This current is delivered with HD-tDCS to parts of the brain that may help with remembering things. The investigators hope that this can help to improve word finding and memory problems in people with TBI.
Leer la descripción completa
The investigators plan to recruit English-speaking participants aged 18-85 years with a history of chronic TBI (\> 1 year since injury prior to enrollment), all of whom have problems with cognition. The participants will be randomized to receive (1) active first followed by sham HD-tDCS condition, or (2) sham first followed by active condition in order to assess the efficacy of HD-tDCS on improving verbal retrieval function. The randomization will be double-blinded to the participants and the research personnel who administer the procedures. The study therefore adopts a double-blind randomized cross-over design. The proposed study will measure response to HD-tDCS treatment over the pre-supplementary motor area (preSMA) region when compared to sham with verbal retrieval function (verbal fluency, naming, verbal learning) as the primary outcome. Secondary outcome measures include cognitive performance other than verbal retrieval function and electroencephalography (EEG) measures. The participants will receive two phases of 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA for 20 min) or sham across 2 weeks. All participants will be blinded to their condition. EEG and neuropsychological tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up. The participants will also undergo an MRI session at baseline. Those participants randomized into the active or sham group will have the opportunity to return after 2 months and receive sham (if active first) or active (if sham first) treatment and will undergo the EEG and neuropsychological tests again immediately following the last HD-tDCS session and at a 2-month follow-up.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Age between 18 and 85
- Fluent in speaking and reading English
- Able to provide informed consent
- Has a TBI at least one year prior to enrollment and not related to military experience
- Has a confirmation of verbal retrieval difficulties as measured by the Verbal Retrieval Difficulty Interview questions
Exclusion Criteria:
- Lifetime major or active neurologic conditions (e.g., stroke, epilepsy, brain tumor, dementia, seizure occurrence less than one year ago)
- Lifetime major or active cardiovascular conditions (e.g., cardiac arrythmia, heart failure, heart attack)
- Current substance use disorder
- Lifetime major psychiatric disorders (e.g., schizophrenia, bipolar disorder)
- Severe depression at the time of enrollment (BDI-II \>= 29) or psychiatric ER visits or hospitalization less than 6 months ago prior to enrollment
- Current sensory (e.g., blind, deaf) or physical (e.g., severe motor weakness) impairment that interferes with testing
- Contraindications for tDCS or MRI
- The person cannot be left alone for 8+ hours.
- Not verbally communicative.
- Currently undergoing and not wishing to discontinue speech and cognitive therapy during study participation.
- Incapable of understanding the consent or unable to consent for oneself.
- Unable to travel to BIDMC's Berenson-Allen Center
- Pregnancy
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento triple
Active to Sham Transcranial direct current stimulation
Subjects in this arm will first be randomly assigned to receive active stimulation. After completion of active stimulation, subjects will be assigned to sham stimulation.
Device: Active Transcranial direct current stimulation · Device: Sham Transcranial direct current stimulation
Sham to Active transcranial direct current stimulation
Subjects in this arm will first be randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects will be assigned to active stimulation.
Device: Active Transcranial direct current stimulation · Device: Sham Transcranial direct current stimulation
Active Transcranial direct current stimulation DEVICE
Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim 20 or 32. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.
Sham Transcranial direct current stimulation DEVICE
Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim 20 or 32. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
The Controlled Oral Word Association Test - letter fluency
Plazo: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change on the Control Word Association Test. Metric: Number of Correct Items Generated
The Controlled Oral Word Association Test - category fluency
Plazo: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change on Category Fluency. Metric: Number of Correct Items Generated
The Boston Naming Test
Plazo: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test. Metric: Number of Correct Items Generated.
The Delis Kaplan Color Word Interference Test
Plazo: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time to Name Items
Rey Auditory Verbal Learning Test and alternative lists
Plazo: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls.
Medidas secundarias
The Trail Making Test (Parts A & B)
Plazo: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution
Digit Span Forward & Backward
Plazo: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change in Digit Span Forward \& Backward. Metric: Memory Span
Rey-Osterrieth Complex Figure Test
Plazo: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change in Rey-Osterrieth Complex Figure Test scores. Metric: Score
The Digit Symbol Substitution Test
Plazo: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change on the Digit Symbol Substitution Test. Metric: Number of Items
Task-based electroencephalography (EEG) markers during a Go-NoGo task
Plazo: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in EEG change on a Go-NoGo task with different levels of perceptual/semantic complexity. Metric: event-related potentials and time frequency changes.
Task-based electroencephalography (EEG) markers during a Semantic Object Memory Retrieval task
Plazo: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in EEG change on a Semantic Object Retrieval task. Metric: event-related potentials and time frequency changes.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Beth Israel Deaconess Medical CenterBoston, Massachusetts, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- Beth Israel Deaconess Medical Center
- Inicio del estudio
- 1 oct 2025 Real
- Finalización primaria
- 30 abr 2028 Estimado
- Finalización del estudio
- 30 abr 2028 Estimado
- Primera publicación
- 26 feb 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Using High Definition Transcranial Direct Current Stimulation to Treat Verbal Retrieval Deficits Secondary to Chronic Traumatic Brain Injury (STIM-CTBI)
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026