Precuneus Mapping With Sinaptistim® (an Investigational TMS-EEG System) in Mild to Moderate AD Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Proportion of participants with quality EEG recordings
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •If treated with a cholinesterase inhibitor for symptoms related to Alzheimer's disease, the dose must be stable for at least 12 weeks before signing informed consent.
- •Documented cognitive impairment with decline in memory for more than 6 months before signing informed consent
- •Clinical stage 4 or 5 Alzheimer's disease with biological confirmation
- •MMSE score 18 to 26 inclusive at Screening
- •Screening CDR Global Score of 0.5 to 2.0, with CDR Memory Box score of at least 0.5 plus one additional domain Box score of at least 0.5
排除标准
- •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.
- •Prior treatment with an anti-amyloid monoclonal antibody for Alzheimer's disease that is:
- •Less than 6 months of continuous treatment immediately before informed consent, or
- •Not at a stable label-recommended maintenance dose/maximally tolerated dose, or
- •Interrupted for > 8 consecutive weeks during that 6-month period, or
- •Associated at any time prior to informed consent with ARIA-E or ARIA-H (including microhemorrhage, superficial siderosis, or macro hemorrhage) that resulted in temporary or permanent interruption, delay, or discontinuation of anti-amyloid monoclonal antibody treatment.
- •Current use of, or plan to initiate any brain stimulation therapy before completion of this study.
- •Current use of medications that may alter cortical excitability, seizure threshold, sedation, or interpretation of treatment response.
- •Clinical history, laboratory findings, or neuroimaging findings consistent with any significant clinical neurodegenerative or neurologic disorder, cerebrovascular disease, structural intracranial abnormality or central nervous system lesion that may increase risk with TMS or confound study assessments.
- •History of seizure disorder, epilepsy, unprovoked seizure, or any seizure considered by the investigator to indicate increased risk with TMS.
- •Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study, including inability to comply with study requirements.
研究组 & 干预措施
Observational Mild to Moderate AD Cohort
We will enroll up to 30 adults, age 65 to 85, with clinical stage 4 or 5 AD including biological confirmation. Eligible participants will have a MRI and complete a TMS-EEG mapping session.
干预措施: TMS-EEG (Device)
结局指标
主要结局
Proportion of participants with quality EEG recordings
时间窗: Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
Proportion of enrolled participants with successful completion of the protocol-defined device mapping procedure and acquisition of EEG data meeting predefined quality criteria
次要结局
- Procedural safety and device-related events(Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort)
- Proportion of completed TMS-EEG mapping sessions(Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort)
- Critical-task Success Ratings from Site Staff(Study start through study closeout, approximately 6 months)
- Screening, eligibility, and enrollment feasibility(Study start through study closeout, approximately 6 months.)