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

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Ali Rezai
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Updated on 5 August 2020
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depression
ischemia
alzheimer's disease
mini-mental state examination
cognitive decline
cognitive training
mini mental state exam
mental state examination

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

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.

Details
Condition Dementia, Dementia, Alzheimer's Disease, Alzheimer's Disease
Age 50years - 85years
Treatment TMS stimulation with X-Torp task, TMS-Stimulation with MindMotion Go, TMS-Sham with X-Torp task, TMS-Sham with MindMotion Go
Clinical Study IdentifierNCT04440891
SponsorAli Rezai
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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depression
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