Using Non-invasive Brain Stimulation to Treat Word Finding Difficulty in Chronic Traumatic Brain Injury

Официальное название

Using High Definition Transcranial Direct Current Stimulation to Treat Verbal Retrieval Deficits Secondary to Chronic Traumatic Brain Injury (STIM-CTBI)

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Active Transcranial direct current stimulation
  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
• Устройство Sham Transcranial direct current stimulation
  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 sec

Первичные конечные точки

• The Controlled Oral Word Association Test - letter fluency [Срок оценки: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.]
• The Controlled Oral Word Association Test - category fluency [Срок оценки: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.]
• The Boston Naming Test [Срок оценки: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.]
• The Delis Kaplan Color Word Interference Test [Срок оценки: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.]
• Rey Auditory Verbal Learning Test and alternative lists [Срок оценки: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.]

Вторичные конечные точки (6)

• The Trail Making Test (Parts A & B) [Срок оценки: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.]
• Digit Span Forward & Backward [Срок оценки: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.]
• Rey-Osterrieth Complex Figure Test [Срок оценки: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.]
• The Digit Symbol Substitution Test [Срок оценки: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.]
• Task-based electroencephalography (EEG) markers during a Go-NoGo task [Срок оценки: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.]
• Task-based electroencephalography (EEG) markers during a Semantic Object Memory Retrieval task [Срок оценки: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Beth Israel Deaconess Medical Center — Boston

Идентификаторы

NCT: NCT06848140 · 2025P000171 · 4R00DC020185-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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