Transcranial Magnetic Stimulation in Mild Cognitive Impairment and Alzheimer Disease

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: Alzheimer Disease; Mild Cognitive Impairment
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation

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

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

How is the study designed?

Number of groups / cohorts

3

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	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

Collaborators and Investigators

• Sponsor: The New York Memory Services
• Investigators: Principal Investigator: Gayatri Devi, MD, NY Memory

Study record dates

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: Transcranial Magnetic Stimulation; TMS
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• 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