Transcranial Magnetic Stimulation in Mild Cognitive Impairment and Alzheimer Disease

Completed

• Conditions: Alzheimer Disease; Mild Cognitive Impairment
• Interventions: Device: Transcranial Magnetic Stimulation

• Registration Number: NCT04771845
• Lead Sponsor: The New York Memory Services

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.

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 Timeline

• Study Start: 2008-05-01
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-30
• Status Verified: 2021-02
• Study First Submitted: 2021-02-07
• Study First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Study First Posted: 2021-02-25
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MRI-guided-TMS	Transcranial Magnetic Stimulation	Patients with Alzheimer disease and mild cognitive impairment receiving TMS using MRI guided navigation
EEG-grid-guided-TMS	Transcranial Magnetic Stimulation	Patients with Alzheimer disease and mild cognitive impairment receiving TMS using electroencephalogram grid guided navigation

Primary Outcome Measures

Name	Time	Method
Controlled Oral Word Association Test	05/01/2008-05/30/2020	Animal score and percentile
Boston 30-item naming test	05/01/2008-05/30/2020	total correct (with cues)
Wechsler Adult Intelligence Scale III	05/01/2008-05/30/2020	object assembly
Wechsler Memory Scale III	05/01/2008-05/30/2020	Visual delayed memory score and percentile
Buschke Selective Reminding Test, 12 item	05/01/2008-05/30/2020	Total recall score
Rosen Drawing Test	05/01/2008-05/30/2020	Total score
Buschke Selective Reminding Test, 12 item, 15 minute	05/01/2008-05/30/2020	Delayed recall score
Processing speed	05/01/2008-05/30/2020	Total score and percentile
Mini-mental status examination	05/01/2008-05/30/2020	Total score