Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    60
  • sponsor
    Saint Vincent's Hospital, Korea
Updated on 23 March 2022
cognitive impairment
mild cognitive impairment
amyloid
polysomnography
amyloid deposition

Summary

This study aims to validate the safety and impact of transdermal trigeminal electrical neuromodulation(Cefaly) on mild cognitive impairment patients with insomnia on brain functional and structural connectivity as well as sleep parameters evidenced by polysomnography and sleep surveys, with consideration for amyloid positivity and brain-derived neurotrophic factor .

Description

This study aims to validate the safety and impact of transdermal trigeminal electrical neuromodulation(Cefaly) on mild cognitive impairment patients with insomnia on brain functional and structural connectivity as well as sleep parameters evidenced by polysomnography and sleep surveys, with consideration for amyloid positivity and brain-derived neurotrophic factor . A 3-month intervention with transdermal trigeminal electrical neuromodulation will be implemented and sleep surveys, polysomnography and brain MRI will be attained both at baseline and post-intervention.

Details
Condition Insomnia, Alzheimer Disease, Mild Cognitive Impairment, Amyloid
Treatment Transdermal trigeminal electrical neuromodulation(Cefaly)
Clinical Study IdentifierNCT05200897
SponsorSaint Vincent's Hospital, Korea
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed with mild cognitive impairment by modified Peterson's criteria
Identified as amyloid positive by amyloid PET result
Insomnia severity index of more than 15 or diagnosed with insomnia disorder by Diagnostic Statistical Manual-5

Exclusion Criteria

Subjects with active psychiatric or neurological disorders
Unstable medical conditions (Myocardial infarction, cerebral infarction, congestive heart failures etc.)
Moderate to severe obstructive sleep apnea (apnea hypopnea index of more than 15), rapid eye movement disorder, narcolepsy
On regular hypnotic medication (can enroll if there was 2-week wash out period)
Currently receiving or having a past history of cognitive behavioral therapy for insomnia
Patients who received transcranial magnetic stimulation (TMS), transcranial direct current stimulation, within 2 weeks before enrollment
Who are on cognitive enhancers (choline alfoscerate, acetylcarnitine, acetylcholinesterase inhibitors, NMDA receptor antagonist)
History of cerebral infarction or Parkinson's disease
History of facial or brain trauma
A subject with allergy to acrylic acid
A subject who is sensitive to electrical devices
A subject who are uncooperative to MRI process
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