Application of TMS Coupled With VR for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease
- Conditions
- Alzheimer Disease
- Interventions
- Device: TMS-Sham with MindMotion GoDevice: TMS-Stimulation with MindMotion GoDevice: TMS stimulation with X-Torp taskDevice: TMS-Sham with X-Torp task
- Registration Number
- NCT04440891
- Lead Sponsor
- Ali Rezai
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TMS-Sham with MindMotion Go TMS-Sham with MindMotion Go TMS sham control with sham VR 2 TMS-Stimulation with MindMotion Go TMS-Stimulation with MindMotion Go TMS with VR 2 experimental arm TMS-Stimulation with X-Torp task TMS stimulation with X-Torp task TMS with VR 1 experimental arm TMS-Sham with X-Torp task TMS-Sham with X-Torp task TMS sham control with VR 1
- Primary Outcome Measures
Name Time Method Cognitive Performance 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)
- Secondary Outcome Measures
Name Time Method Brain MRI 6 months after completion of study procedure compared to screening Change in brain structure and function over time
Memory Performance 6 months after completion of study procedure compared to screening Total recall on the California Verbal Learning Test - short form (range 0-36)
Trial Locations
- Locations (1)
West Virginia University Rockefeller Neuroscience Institute
🇺🇸Morgantown, West Virginia, United States