Transcranial magnetic stimulation (TMS), electroencephalography (EEG), and combined TMS-EEG approaches have been used in human research to characterize cortical excitability and network-level neurophysiologic responses. The SinaptiStim System is an investigational integrated TMS-EEG platform designed to synchronize TMS delivery, EEG acquisition, and is intended to support standardized characterization of neurophysiologic responses and individualized mapping of stimulation parameters relevant to later therapeutic use.
The rationale for this early single-site, non-treatment study is to obtain initial clinical evidence that the investigational device can be used safely and as intended in participants with mild to moderate Alzheimer's disease (AD), can acquire EEG data of sufficient quality for the planned application, and can be implemented operationally at the clinical site with appropriate training and usability prior to launch of a larger treatment trial.
The study involves two visits, a screening visit with magnetic resonance imaging (MRI) followed by a TMS-EEG mapping visit. Participants who complete this study successfully may be invited to provide informed consent for screening and potential enrollment in a future treatment protocol. This study does not include randomization or a sham control group or therapeutic treatment.
Must have a reliable study partner with at least 10 hours per week of direct or indirect contact. The study partner must be willing and able to provide informed consent, participate in the study visits and provide information for protocol-required assessments.
Participant and study partner must each provide signed informed consent before initiation of any study-specific assessments or procedures.
65 to 85 years of age
Stable non-AD medications for at least 4 weeks before signing informed consent
Any contraindication to MRI required by the protocol, including non-compatible implanted metal or electronic devices, ferromagnetic intracranial or other unsafe metallic implants, severe claustrophobia not manageable per site practice, or any other condition making MRI unsafe or not feasible.
Current participation in another interventional clinical study, or receipt of any investigational drug, biologic, or device within 3 months before signing informed consent.
Less than 6 months of continuous treatment immediately before informed consent, or
Not at a stable label-recommended maintenance dose/maximally tolerated dose, or
Patients 65-85 years of age with mild (stage 4) or moderate (stage 5) AD
Cohort
Prospective
TMS-EEG
DeviceA non-therapeutic transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) assessment to evaluate cortical excitability and network-level brain responses.
Proportion of participants with quality EEG recordings
Proportion of enrolled participants with successful completion of the protocol-defined device mapping procedure and acquisition of EEG data meeting predefined quality criteria
Procedural safety and device-related events
Incidence of device-related adverse events, adverse device effects, serious adverse events, and device deficiencies observed during the study visit and immediate post-procedure period.
Proportion of completed TMS-EEG mapping sessions
Proportion of attempted sessions completed per protocol without major technical failure and with EEG data meeting predefined technical quality criteria.
Critical-task Success Ratings from Site Staff
Site staff critical-task success and structured ratings of ease of use, workflow fit, and training adequacy. This will be assessed via clinician and technician interviews using sponsor developed questionnaires and interviews.
Screening, eligibility, and enrollment feasibility
Number screened, number eligible, number enrolled, proportion eligible, and reasons for screen failure or non-enrollment.
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