Clinical trial NCT04771845: Transcranial Magnetic Stimulation in Mild Cognitive Impairment and Alzheimer Disease
Official title: Transcranial Magnetic Stimulation (TMS) in Patients With Mild Cognitive Impairment (MCI) and Alzheimer Disease (AD): A Twelve-year Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Keywords: TMS
Transcranial Magnetic Stimulation
Lead sponsor: The New York Memory Services
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 73
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Alzheimer disease or mild cognitive impairment.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Controlled Oral Word Association Test
timeFrame: 05/01/2008-05/30/2020
measure: Boston 30-item naming test
timeFrame: 05/01/2008-05/30/2020
measure: Boston 30-item naming test
timeFrame: 05/01/2008-05/30/2020
measure: Wechsler Adult Intelligence Scale III
timeFrame: 05/01/2008-05/30/2020
measure: Wechsler Adult Intelligence Scale III
timeFrame: 05/01/2008-05/30/2020
measure: Wechsler Adult Intelligence Scale III
timeFrame: 05/01/2008-05/30/2020
measure: Wechsler Adult Intelligence Scale III
timeFrame: 05/01/2008-05/30/2020
measure: Wechsler Memory Scale III
timeFrame: 05/01/2008-05/30/2020
measure: Wechsler Memory Scale III
timeFrame: 05/01/2008-05/30/2020
measure: Wechsler Memory Scale III
timeFrame: 05/01/2008-05/30/2020
measure: Buschke Selective Reminding Test, 12 item
timeFrame: 05/01/2008-05/30/2020
measure: Buschke Selective Reminding Test, 12 item, 15 minute
timeFrame: 05/01/2008-05/30/2020
measure: Rosen Drawing Test
timeFrame: 05/01/2008-05/30/2020
measure: Processing speed
timeFrame: 05/01/2008-05/30/2020
measure: Mini-mental status examination
timeFrame: 05/01/2008-05/30/2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NY Memory
name: Gayatri Devi, MD
role: PRINCIPAL_INVESTIGATOR
References: