Study Stopped
Difficulty with recruitment due to Covid. 3 subjects consented but did not start any study procedures or participate in the study.
Application of TMS Coupled With VR for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease
TMS_AD
Application of Transcranial Magnetic Stimulation Coupled With Virtual Reality for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease
1 other identifier
interventional
N/A
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2019
CompletedFirst Submitted
Initial submission to the registry
May 22, 2020
CompletedFirst Posted
Study publicly available on registry
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2021
CompletedAugust 14, 2023
August 1, 2023
2.1 years
May 22, 2020
August 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Brain MRI
6 months after completion of study procedure compared to screening
Memory Performance
6 months after completion of study procedure compared to screening
Study Arms (4)
TMS-Stimulation with X-Torp task
EXPERIMENTALTMS with VR 1 experimental arm
TMS-Stimulation with MindMotion Go
EXPERIMENTALTMS with VR 2 experimental arm
TMS-Sham with X-Torp task
SHAM COMPARATORTMS sham control with VR 1
TMS-Sham with MindMotion Go
SHAM COMPARATORTMS sham control with sham VR 2
Interventions
TMS-Stimulation with X-Torp task
TMS-Stimulation with MindMotion Go
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ali Rezailead
Study Sites (1)
West Virginia University Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marc Haut, PhD
Rockefeller Neuroscience Institute
- STUDY DIRECTOR
Victor Finomore, PhD
Rockefeller Neuroscience Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
May 22, 2020
First Posted
June 22, 2020
Study Start
October 3, 2019
Primary Completion
November 2, 2021
Study Completion
November 2, 2021
Last Updated
August 14, 2023
Record last verified: 2023-08