Application of Transcranial Magnetic Stimulation Coupled With Virtual Reality for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Ali Rezai
- 试验地点
- 1
- 主要终点
- Cognitive Performance
研究概览
简要总结
This is a randomized sham control study to evaluate how repetitive Transcranial Magnetic Stimulation (rTMS), interactive cognitive training, or the combination of rTMS and cognitive training reduce the cognitive decline of patients diagnosed with Alzheimer's disease
详细描述
Participants may be assigned to one of four experimental arms (1-TMS-Stimulation with X-Torp task, 2-TMS-Stimulation with MindMotion Go, 3-TMS-Sham with X-Torp task, 4-TMS-Sham with MindMotion Go.) The study will be conducted in two phases. During Phase 1, participants will be randomized between experimental conditions 1 and 4. Data will be analyzed upon completion of Phase1 and Phase 2 will commence only if there is efficacy in the TMS arm. During Phase2, participants will be randomized to arms 2 and 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female between 50-85 years of age
- •Able and willing to give informed consent
- •Probable AD consistent with NIA/AA criteria
- •Modified Hachinski Ischemia Scale (MHIS) score of <= 4
- •Geriatric Depression Scale (GDS) score of <= 6
- •Mini Mental State Exam (MMSE) score 18-
- •The MMSE adjusted scoring instructions may be followed for screening patients as applicable.
排除标准
- •Unstable medical conditions
- •Visual impairments
- •Mobility limitations
- •Cognition-enhancing medication unless on a stable dosage for at least 3 months before the start of the trial.
- •History of epilepsy or seizure disorder
- •History of psychosis
- •Current thoughts of suicidal ideation or self-harm as assessed by the Columbia-Suicide severity rating scale score
- •Progressive neurological disorder or focal signs of abnormality on neurological exam as conducted by a neurologist (other than current diagnosis of AD)
- •Metal implants (excluding dental fillings)
- •Possible pregnancy
- •Substance use disorder within the past six months
- •Have other mental or physical conditions that are inappropriate for study participation at PI's or delegated sub investigator's discretion.
- •Intake of one or a combination of the drugs that may due to their significant seizure threshold lowering potential
研究组 & 干预措施
TMS-Stimulation with MindMotion Go
TMS with VR 2 experimental arm
干预措施: TMS-Stimulation with MindMotion Go (Device)
TMS-Stimulation with X-Torp task
TMS with VR 1 experimental arm
干预措施: TMS stimulation with X-Torp task (Device)
TMS-Sham with X-Torp task
TMS sham control with VR 1
干预措施: TMS-Sham with X-Torp task (Device)
TMS-Sham with MindMotion Go
TMS sham control with sham VR 2
干预措施: TMS-Sham with MindMotion Go (Device)
结局指标
主要结局
Cognitive Performance
时间窗: 6 months after completion study procedure
Change in cognitive task performance over time using the total score on the Mini Mental State Examination (range 0-30)
次要结局
- Brain MRI(6 months after completion of study procedure compared to screening)
- Memory Performance(6 months after completion of study procedure compared to screening)