Transcranial Magnetic Stimulation in Mild Cognitive Impairment and Alzheimer Disease

February 22, 2021 updated by: Gayatri Devi, MD, The New York Memory Services

Transcranial Magnetic Stimulation (TMS) in Patients With Mild Cognitive Impairment (MCI) and Alzheimer Disease (AD): A Twelve-year Retrospective Observational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators compiled demographic, clinical, and neurocognitive data on all patients who had received TMS for any reason in the clinic over a 12-year period. Of 236 patients receiving TMS, 59 patients with AD and 14 with MCI satisfied study criteria and were compared to controls from the National Alzheimer's Coordinating Center (NACC). Neurocognitive outcomes were compared between magnetic resonance imaging (MRI) and electroencephalogram (EEG)-grid guided TMS in patients. Tolerability data was reviewed for all patients.

Study Type

Observational

Enrollment (Actual)

73

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Alzheimer disease or mild cognitive impairment.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EEG-grid-guided-TMS
Patients with Alzheimer disease and mild cognitive impairment receiving TMS using electroencephalogram grid guided navigation
Device: Transcranial Magnetic Stimulation
Magnetic stimulation to alter neural activity
Other Names:
  • TMS
MRI-guided-TMS
Patients with Alzheimer disease and mild cognitive impairment receiving TMS using MRI guided navigation
Device: Transcranial Magnetic Stimulation
Magnetic stimulation to alter neural activity
Other Names:
  • TMS
NACC controls
National Alzheimer's Coordinating Center matched controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Controlled Oral Word Association Test
Time Frame: 05/01/2008-05/30/2020
Animal score and percentile
05/01/2008-05/30/2020
Boston 30-item naming test
Time Frame: 05/01/2008-05/30/2020
spontaneous correct (without cues)
05/01/2008-05/30/2020
Boston 30-item naming test
Time Frame: 05/01/2008-05/30/2020
total correct (with cues)
05/01/2008-05/30/2020
Wechsler Adult Intelligence Scale III
Time Frame: 05/01/2008-05/30/2020
Digit span
05/01/2008-05/30/2020
Wechsler Adult Intelligence Scale III
Time Frame: 05/01/2008-05/30/2020
verbal quotient score and percentile
05/01/2008-05/30/2020
Wechsler Adult Intelligence Scale III
Time Frame: 05/01/2008-05/30/2020
performance quotient score and percentile
05/01/2008-05/30/2020
Wechsler Adult Intelligence Scale III
Time Frame: 05/01/2008-05/30/2020
object assembly
05/01/2008-05/30/2020
Wechsler Memory Scale III
Time Frame: 05/01/2008-05/30/2020
Immediate memory score and percentile
05/01/2008-05/30/2020
Wechsler Memory Scale III
Time Frame: 05/01/2008-05/30/2020
Auditory delayed memory score and percentile
05/01/2008-05/30/2020
Wechsler Memory Scale III
Time Frame: 05/01/2008-05/30/2020
Visual delayed memory score and percentile
05/01/2008-05/30/2020
Buschke Selective Reminding Test, 12 item
Time Frame: 05/01/2008-05/30/2020
Total recall score
05/01/2008-05/30/2020
Buschke Selective Reminding Test, 12 item, 15 minute
Time Frame: 05/01/2008-05/30/2020
Delayed recall score
05/01/2008-05/30/2020
Rosen Drawing Test
Time Frame: 05/01/2008-05/30/2020
Total score
05/01/2008-05/30/2020
Processing speed
Time Frame: 05/01/2008-05/30/2020
Total score and percentile
05/01/2008-05/30/2020
Mini-mental status examination
Time Frame: 05/01/2008-05/30/2020
Total score
05/01/2008-05/30/2020

Collaborators and Investigators

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

Sponsor

The New York Memory Services

Investigators

  • Principal Investigator: Gayatri Devi, MD, NY Memory

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)

May 1, 2008

Primary Completion (ACTUAL)

May 30, 2020

Study Completion (ACTUAL)

May 30, 2020

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (ACTUAL)

February 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-0812

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

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.

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