Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia

Обзор

This research study investigates the feasibility and efficacy of a personalized, closed-loop electroencephalogram-transcranial electrical stimulation (EEG-tES) intervention for individuals with Primary Progressive Aphasia (PPA), addressing the inconsistent results of generic brain stimulation protocols. By integrating artificial intelligence (AI)-derived insights with real-time data, the study aims to customize transcranial electrical stimulation (tES) parameters, including electrode placement, intensity, and frequency to target the specific brain regions responsible for abnormal signaling in each participant. Over the intervention period paired with computerized cognitive training, the project will evaluate improvements in learning, memory, and functional connectivity, while simultaneously identifying clinical and physiological predictors to determine the viability of transitioning this low-cost, non-invasive technology into a remotely supervised, home-based therapy setting. The study duration will be a total of 6-8 weeks.

Вмешательства

• Устройство Active tES
  This three-week, closed-loop program integrates personalized tES with computerized cognitive training to drive neuroplasticity. Following baseline electroencephalogram (EEG) mapping, participants undergo daily 30-minute sessions consisting of four "loops." Each loop begins with an AI-analyzed EEG to calibrate stimulation parameters, followed by 5-minute stimulation periods.
• Поведенческое Cognitive Interventions
  In between tES treatment loops, the participants will be asked to complete cognitive exercises. By pairing real-time brain modulation with targeted executive function exercises, the intervention aims to improve language skills and clinical outcomes through precise, data-driven cortical targeting.

Первичные конечные точки

• Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically related - trained word-lists [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in auditory delayed recall accuracy of semantically related - trained word-lists [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically unrelated - trained word-lists [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in auditory delayed recall accuracy of semantically unrelated - trained word-lists [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in auditory recall accuracy based the sum of words recalled in Trials 1-5 of semantically related - untrained word-lists [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in auditory delayed recall accuracy of semantically related - untrained word-lists [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically unrelated - untrained word-lists [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in auditory delayed recall accuracy of semantically unrelated - untrained word-lists [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]

Вторичные конечные точки (12)

• Change in Rey Auditory-Verbal Learning Test (RAVLT) score [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in Mini Mental State Examination (MMSE) [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in Mnemonic Similarity Task (MST) score [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in word repetition score [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in non-word repetition score [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in sentence repetition score [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in oral naming Boston Naming Test score [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in oral naming Philadelphia Naming Test score [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in written naming as assessed by Boston Naming Test [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in written naming as assessed by Philadelphia Naming Test [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in oral naming of action as assessed by Hopkins Assessment of Naming Actions (HANA) [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]
• Change in syntactic comprehension as assessed by Subject-relative, Object-relative, Active, Passive (S.O.A.P.) Syntactic Battery [Срок оценки: Before intervention, immediately after intervention and 1 month post intervention]

Критерии участия

Критерии включения

• Must be between 45-85 years of age.
• Must be right-handed.
• Must be proficient in English.
• Must have a minimum of high-school education.
• Must be diagnosed as lvPPA with AD biomarkers. Other possible diagnosis for the 'aphasic AD' variant would be MCI or 'possible AD' according to 2011 guidelines with AD biomarkers (CSF or positron emission tomography (PET) amyloid-beta or fluorodeoxyglucose (FDG)-positron emission tomography (PET) with uni-hemispheric atrophy).
• Participants will be diagnosed from PPA and early dementias clinics at Johns Hopkins University or other specialized centers in US using current consensus criteria. Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment. The investigators will also use two new variant classification tests the investigators have developed at the lab which discriminate PPA variants with great accuracy (above 80%): a spelling test and a speech production test (i.e., Cookie Theft picture description task).

Критерии исключения

• People with previous neurological disease including vascular dementia (e.g., stroke, developmental dyslexia, dysgraphia or attentional deficit).
• People with hearing loss (> 25 decibel, using audiometric hearing screen).
• People with uncorrected visual acuity loss.
• People with advanced dementia or severe language impairments (MMSE <15, or Montreal Cognitive Assessment <10, or language Frontotemporal Dementia-specific Clinical Dementia Rating (FTD-CDR) =3).
• Left-handed individuals.
• People with pre-existing psychiatric disorders such as behavioral disturbances, severe depression, or schizophrenia that do not allow these people to comply or follow the study schedule and requirements such as repeated evaluation and therapy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Johns Hopkins Hospital — Baltimore

Идентификаторы

NCT: NCT07511179 · IRB00557243

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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