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

NCT ID: NCT04440891

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-03

Study Completion Date

2021-11-02

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TMS-Stimulation with X-Torp task

TMS with VR 1 experimental arm

Group Type EXPERIMENTAL

TMS stimulation with X-Torp task

Intervention Type DEVICE

TMS-Stimulation with X-Torp task

TMS-Stimulation with MindMotion Go

TMS with VR 2 experimental arm

Group Type EXPERIMENTAL

TMS-Stimulation with MindMotion Go

Intervention Type DEVICE

TMS-Stimulation with MindMotion Go

TMS-Sham with X-Torp task

TMS sham control with VR 1

Group Type SHAM_COMPARATOR

TMS-Sham with X-Torp task

Intervention Type DEVICE

TMS-Sham with X-Torp task

TMS-Sham with MindMotion Go

TMS sham control with sham VR 2

Group Type SHAM_COMPARATOR

TMS-Sham with MindMotion Go

Intervention Type DEVICE

TMS-Sham with MindMotion Go

Interventions

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TMS stimulation with X-Torp task

TMS-Stimulation with X-Torp task

Intervention Type DEVICE

TMS-Stimulation with MindMotion Go

TMS-Stimulation with MindMotion Go

Intervention Type DEVICE

TMS-Sham with X-Torp task

TMS-Sham with X-Torp task

Intervention Type DEVICE

TMS-Sham with MindMotion Go

TMS-Sham with MindMotion Go

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ali Rezai

OTHER

Sponsor Role lead

Responsible Party

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Ali Rezai

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marc Haut, PhD

Role: STUDY_CHAIR

Rockefeller Neuroscience Institute

Victor Finomore, PhD

Role: STUDY_DIRECTOR

Rockefeller Neuroscience Institute

Locations

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West Virginia University Rockefeller Neuroscience Institute

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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1904522298

Identifier Type: -

Identifier Source: org_study_id

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