Application of TMS Coupled With VR for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease (TMS_AD)
Primary Purpose
Alzheimer Disease
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMS stimulation with X-Torp task
TMS-Stimulation with MindMotion Go
TMS-Sham with X-Torp task
TMS-Sham with MindMotion Go
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
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
Sites / Locations
- West Virginia University Rockefeller Neuroscience Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Sham Comparator
Sham Comparator
Arm Label
TMS-Stimulation with X-Torp task
TMS-Stimulation with MindMotion Go
TMS-Sham with X-Torp task
TMS-Sham with MindMotion Go
Arm Description
TMS with VR 1 experimental arm
TMS with VR 2 experimental arm
TMS sham control with VR 1
TMS sham control with sham VR 2
Outcomes
Primary Outcome Measures
Cognitive Performance
Change in cognitive task performance over time using the total score on the Mini Mental State Examination (range 0-30)
Secondary Outcome Measures
Brain MRI
Change in brain structure and function over time
Memory Performance
Total recall on the California Verbal Learning Test - short form (range 0-36)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04440891
Brief Title
Application of TMS Coupled With VR for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease
Acronym
TMS_AD
Official Title
Application of Transcranial Magnetic Stimulation Coupled With Virtual Reality for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty with recruitment due to Covid. 3 subjects consented but did not start any study procedures or participate in the study.
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
November 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ali Rezai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TMS-Stimulation with X-Torp task
Arm Type
Experimental
Arm Description
TMS with VR 1 experimental arm
Arm Title
TMS-Stimulation with MindMotion Go
Arm Type
Experimental
Arm Description
TMS with VR 2 experimental arm
Arm Title
TMS-Sham with X-Torp task
Arm Type
Sham Comparator
Arm Description
TMS sham control with VR 1
Arm Title
TMS-Sham with MindMotion Go
Arm Type
Sham Comparator
Arm Description
TMS sham control with sham VR 2
Intervention Type
Device
Intervention Name(s)
TMS stimulation with X-Torp task
Intervention Description
TMS-Stimulation with X-Torp task
Intervention Type
Device
Intervention Name(s)
TMS-Stimulation with MindMotion Go
Intervention Description
TMS-Stimulation with MindMotion Go
Intervention Type
Device
Intervention Name(s)
TMS-Sham with X-Torp task
Intervention Description
TMS-Sham with X-Torp task
Intervention Type
Device
Intervention Name(s)
TMS-Sham with MindMotion Go
Intervention Description
TMS-Sham with MindMotion Go
Primary Outcome Measure Information:
Title
Cognitive Performance
Description
Change in cognitive task performance over time using the total score on the Mini Mental State Examination (range 0-30)
Time Frame
6 months after completion study procedure
Secondary Outcome Measure Information:
Title
Brain MRI
Description
Change in brain structure and function over time
Time Frame
6 months after completion of study procedure compared to screening
Title
Memory Performance
Description
Total recall on the California Verbal Learning Test - short form (range 0-36)
Time Frame
6 months after completion of study procedure compared to screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Haut, PhD
Organizational Affiliation
Rockefeller Neuroscience Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Victor Finomore, PhD
Organizational Affiliation
Rockefeller Neuroscience Institute
Official's Role
Study Director
Facility Information:
Facility Name
West Virginia University Rockefeller Neuroscience Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Application of TMS Coupled With VR for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease
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