NCT04771845

Brief Summary

The investigators reviewed 12 years of clinical use in an outpatient neurology setting of transcranial magnetic stimulation (TMS) in patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI) to evaluate safety and efficacy of TMS.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

12.1 years

First QC Date

February 7, 2021

Last Update Submit

February 22, 2021

Conditions

Keywords

TMSTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (15)

  • Controlled Oral Word Association Test

    Animal score and percentile

    05/01/2008-05/30/2020

  • Boston 30-item naming test

    spontaneous correct (without cues)

    05/01/2008-05/30/2020

  • Boston 30-item naming test

    total correct (with cues)

    05/01/2008-05/30/2020

  • Wechsler Adult Intelligence Scale III

    Digit span

    05/01/2008-05/30/2020

  • Wechsler Adult Intelligence Scale III

    verbal quotient score and percentile

    05/01/2008-05/30/2020

  • Wechsler Adult Intelligence Scale III

    performance quotient score and percentile

    05/01/2008-05/30/2020

  • Wechsler Adult Intelligence Scale III

    object assembly

    05/01/2008-05/30/2020

  • Wechsler Memory Scale III

    Immediate memory score and percentile

    05/01/2008-05/30/2020

  • Wechsler Memory Scale III

    Auditory delayed memory score and percentile

    05/01/2008-05/30/2020

  • Wechsler Memory Scale III

    Visual delayed memory score and percentile

    05/01/2008-05/30/2020

  • Buschke Selective Reminding Test, 12 item

    Total recall score

    05/01/2008-05/30/2020

  • Buschke Selective Reminding Test, 12 item, 15 minute

    Delayed recall score

    05/01/2008-05/30/2020

  • Rosen Drawing Test

    Total score

    05/01/2008-05/30/2020

  • Processing speed

    Total score and percentile

    05/01/2008-05/30/2020

  • Mini-mental status examination

    Total score

    05/01/2008-05/30/2020

Study Arms (3)

EEG-grid-guided-TMS

Patients with Alzheimer disease and mild cognitive impairment receiving TMS using electroencephalogram grid guided navigation

Device: Transcranial Magnetic Stimulation

MRI-guided-TMS

Patients with Alzheimer disease and mild cognitive impairment receiving TMS using MRI guided navigation

Device: Transcranial Magnetic Stimulation

NACC controls

National Alzheimer's Coordinating Center matched controls

Interventions

Magnetic stimulation to alter neural activity

Also known as: TMS
EEG-grid-guided-TMSMRI-guided-TMS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Alzheimer disease or mild cognitive impairment.

You may qualify if:

  • Patients meeting the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) criteria for possible or probable Alzheimer's disease.
  • Patients meeting the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) criteria for mild cognitive impairment.
  • Patients must have undergone at least two standardized neurocognitive batteries before and after beginning TMS.
  • Patients must have received greater than or equal to five (5) TMS sessions in less than one year.

You may not qualify if:

  • Patients with dementias from other causes, such as Lewy Body disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Gayatri Devi, MD

    NY Memory

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2021

First Posted

February 25, 2021

Study Start

May 1, 2008

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

February 25, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share