Application of TMS Coupled With VR for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Application of Transcranial Magnetic Stimulation Coupled With Virtual Reality for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Device: TMS stimulation with X-Torp task
* Device: TMS-Stimulation with MindMotion Go
* Device: TMS-Sham with X-Torp task
* Device: TMS-Sham with MindMotion Go


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 18-26. The MMSE adjusted scoring instructions may be followed for screening patients as applicable. Exclusion Criteria: 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) Tinnitus 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMS-Stimulation with X-Torp task<br>TMS with VR 1 experimental arm | Device: TMS stimulation with X-Torp task<br>* TMS-Stimulation with X-Torp task<br>|
| Experimental: TMS-Stimulation with MindMotion Go<br>TMS with VR 2 experimental arm | Device: TMS-Stimulation with MindMotion Go<br>* TMS-Stimulation with MindMotion Go<br>|
| Sham Comparator: TMS-Sham with X-Torp task<br>TMS sham control with VR 1 | Device: TMS-Sham with X-Torp task<br>* TMS-Sham with X-Torp task<br>|
| Sham Comparator: TMS-Sham with MindMotion Go<br>TMS sham control with sham VR 2 | Device: TMS-Sham with MindMotion Go<br>* TMS-Sham with MindMotion Go<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Performance | Change in cognitive task performance over time using the total score on the Mini Mental State Examination (range 0-30) | 6 months after completion study procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain MRI | Change in brain structure and function over time | 6 months after completion of study procedure compared to screening | 
| Memory Performance | Total recall on the California Verbal Learning Test - short form (range 0-36) | 6 months after completion of study procedure compared to screening |