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

August 7, 2023 updated by: Ali Rezai

Application of Transcranial Magnetic Stimulation Coupled With Virtual Reality for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Rockefeller Neuroscience Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TMS-Stimulation with X-Torp task
TMS with VR 1 experimental arm
Device: TMS stimulation with X-Torp task
TMS-Stimulation with X-Torp task
Experimental: TMS-Stimulation with MindMotion Go
TMS with VR 2 experimental arm
Device: TMS-Stimulation with MindMotion Go
TMS-Stimulation with MindMotion Go
Sham Comparator: TMS-Sham with X-Torp task
TMS sham control with VR 1
Device: TMS-Sham with X-Torp task
TMS-Sham with X-Torp task
Sham Comparator: TMS-Sham with MindMotion Go
TMS sham control with sham VR 2
Device: TMS-Sham with MindMotion Go
TMS-Sham with MindMotion Go

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Performance
Time Frame: 6 months after completion study procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain MRI
Time Frame: 6 months after completion of study procedure compared to screening
Change in brain structure and function over time
6 months after completion of study procedure compared to screening
Memory Performance
Time Frame: 6 months after completion of study procedure compared to screening
Total recall on the California Verbal Learning Test - short form (range 0-36)
6 months after completion of study procedure compared to screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ali Rezai

Investigators

  • Study Chair: Marc Haut, PhD, Rockefeller Neuroscience Institute
  • Study Director: Victor Finomore, PhD, Rockefeller Neuroscience Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2019

Primary Completion (Actual)

November 2, 2021

Study Completion (Actual)

November 2, 2021

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1904522298

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on TMS stimulation with X-Torp task

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe