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

About this trial

Last updated a month ago

Study ID

IRB00557243

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

45 to 85 Years

All Sexes

Not accepting

Healthy Volunteers

Trial Timing

Started a month ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* 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).

Exclusion Criteria

* 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.