Transcranial Magnetic Stimulation in Mild Cognitive Impairment and Alzheimer Disease

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771845
• Other study ID #: 20-0812
• Status: Completed
• Start date: May 1, 2008
• Est. completion date: May 30, 2020

Study information

• Verified date: February 2021
• Source: The New York Memory Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• Transcranial Magnetic Stimulation
Magnetic stimulation to alter neural activity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The New York Memory Services

Outcome

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