Status:
WITHDRAWN
Application of TMS Coupled With VR for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease
Lead Sponsor:
Ali Rezai
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-85 years
Phase:
NA
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 th...
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.) Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04440891
Start Date
October 3 2019
End Date
November 2 2021
Last Update
August 14 2023
Active Locations (1)
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1
West Virginia University Rockefeller Neuroscience Institute
Morgantown, West Virginia, United States, 26506