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Completed

NCT Number: NCT04771845

Transcranial Magnetic Stimulation in Mild Cognitive Impairment and Alzheimer Disease

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Magnetic Stimulation

Device

Magnetic stimulation to alter neural activity

Other names: TMS

Primary outcomes

  1. Controlled Oral Word Association Test

    Time frame: 05/01/2008-05/30/2020

    Animal score and percentile

  2. Boston 30-item naming test

    Time frame: 05/01/2008-05/30/2020

    spontaneous correct (without cues)

  3. Boston 30-item naming test

    Time frame: 05/01/2008-05/30/2020

    total correct (with cues)

  4. Wechsler Adult Intelligence Scale III

    Time frame: 05/01/2008-05/30/2020

    Digit span

  5. Wechsler Adult Intelligence Scale III

    Time frame: 05/01/2008-05/30/2020

    verbal quotient score and percentile

  6. Wechsler Adult Intelligence Scale III

    Time frame: 05/01/2008-05/30/2020

    performance quotient score and percentile

  7. Wechsler Adult Intelligence Scale III

    Time frame: 05/01/2008-05/30/2020

    object assembly

  8. Wechsler Memory Scale III

    Time frame: 05/01/2008-05/30/2020

    Immediate memory score and percentile

  9. Wechsler Memory Scale III

    Time frame: 05/01/2008-05/30/2020

    Auditory delayed memory score and percentile

  10. Wechsler Memory Scale III

    Time frame: 05/01/2008-05/30/2020

    Visual delayed memory score and percentile

  11. Buschke Selective Reminding Test, 12 item

    Time frame: 05/01/2008-05/30/2020

    Total recall score

  12. Buschke Selective Reminding Test, 12 item, 15 minute

    Time frame: 05/01/2008-05/30/2020

    Delayed recall score

  13. Rosen Drawing Test

    Time frame: 05/01/2008-05/30/2020

    Total score

  14. Processing speed

    Time frame: 05/01/2008-05/30/2020

    Total score and percentile

  15. Mini-mental status examination

    Time frame: 05/01/2008-05/30/2020

    Total score

Sponsors and collaborators

Lead sponsor

The New York Memory Services

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2020
Study completion
2020
First posted
Feb 25, 2021
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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