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RecruitingNCT05200897Updated Nov 22, 2023

Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia

An interventional study of Transdermal trigeminal electrical neuromodulation(Cefaly) in Insomnia, Alzheimer Disease and Mild Cognitive Impairment, sponsored by Saint Vincent's Hospital, Korea. Recruiting at 1 site in Korea, Republic of. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Saint Vincent's Hospital, Korea · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2021; still recruiting 4 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
60 Years to 85 Years
Sex
All
01

Study 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 .

Read the detailed 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.

02

Conditions studied

  • Insomnia
  • Alzheimer Disease
  • Mild Cognitive Impairment
  • Amyloid
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Saint Vincent's Hospital, Korea is the lead sponsor of 19 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Amyloid positive mild cognitive impairment+ BDNF met carrier

    Transdermal trigeminal electrical modulation for 3 months

    Device: Transdermal trigeminal electrical neuromodulation(Cefaly)

  • Experimental
    Amyloid positive mild cognitive impairment+ BDNF Val/Val

    Transdermal trigeminal electrical modulation for 3 months

    Device: Transdermal trigeminal electrical neuromodulation(Cefaly)

  • Experimental
    Amyloid negative mild cognitive impairment+ BDNF met carrier

    Transdermal trigeminal electrical modulation for 3 months

    Device: Transdermal trigeminal electrical neuromodulation(Cefaly)

  • Experimental
    Amyloid negative mild cognitive impairment+ BDNF Val/Val

    Transdermal trigeminal electrical modulation for 3 months

    Device: Transdermal trigeminal electrical neuromodulation(Cefaly)

Interventions

  • DeviceTransdermal trigeminal electrical neuromodulation(Cefaly)

    The Cefaly device delivers electrical micro-impulses through a self-adhesive electrode which is placed over the participant's forehead, where the supratrochlear and supraorbital branches of the ophthalmic division of the trigeminal nerve are located. Rectangular, biphasic impulses with an electrical mean equal to zero are transmitted. The impulse width is 250μs, frequency is 60Hz, and the maximum intensity of 16mA is over 14 minutes

06

What researchers measure

Primary outcomes

  1. Changes from Baseline Pittsburgh sleep quality index(PSQI) at 3 months

    PSQI global score of more than 5 signifies major sleep disturbance, higher scores suggesting greater sleep disturbance

    Time frame: Post 3-month intervention

  2. Changes from Baseline Insomnia severity index(ISI) at 3 months

    ISI is a brief, self-rated scale that is widely used to measure insomnia severity. With seven items scored on a 0-4 scale, it only takes about 5 minutes to complete and scores of 15 or more indicates insomnia of moderate to severe severity

    Time frame: Post 3-month intervention

  3. Changes from Baseline Epworth sleepiness scale(ESS) at 3 months

    ESS is a self-administered scale with eight questionnaires measuring sleepiness in daily life. Score of more than 10 signifies clinically meaningful daytime sleepiness, with higher scores indicating more severe sleepiness.

    Time frame: Post-3 month intervention

  4. Changes from Baseline Total time in bed(TIB) at 3 months

    One of polysomnography measures

    Time frame: Post 3-month intervention

  5. Changes from Baseline Total sleep time(TST) at 3 months

    One of polysomnography measures

    Time frame: Post 3-month intervention

  6. Changes from Baseline Sleep efficiency(SE) at 3 months

    One of polysomnography measures

    Time frame: Post 3-month intervention

  7. Changes from Baseline Proportion of stage 1 sleep(N1, %) at 3 months

    One of polysomnography measures

    Time frame: Post 3-month intervention

  8. Changes from Baseline Proportion of stage 2 sleep(N2, %) at 3 months

    One of polysomnography measures

    Time frame: Post 3-month intervention

  9. Changes from Baseline Proportion of stage 3 sleep(N3, %) at 3 months

    One of polysomnography measures

    Time frame: Post 3-month intervention

  10. Changes from Baseline Proportion of REM sleep(R, %) at 3 months

    One of polysomnography measures

    Time frame: Post 3-month intervention

  11. Changes from Baseline REM sleep latency(REML) at 3 months

    One of polysomnography measures

    Time frame: Post 3-month intervention

  12. Changes from Baseline Sleep latency(SL) at 3 months

    One of polysomnography measures

    Time frame: Post 3-month intervention

  13. Changes from Baseline Apnea-hypopnea index(AHI) at 3 months

    One of polysomnography measures

    Time frame: Post 3-month intervention

  14. Changes from Baseline Limb movement index(LMI) at 3 months

    One of polysomnography measures

    Time frame: Post 3-month intervention

  15. Changes from Baseline Periodic limb movement index(PLMI) at 3 months

    One of polysomnography measures

    Time frame: Post 3-month intervention

  16. Changes from Baseline Cortical thickness changes at 3 months

    One of neuroimaging measures

    Time frame: Post 3-month intervention

  17. Changes from Baseline Functional connectivity measure at 3 months

    One of neuroimaging measures

    Time frame: Post 3-month intervention

  18. Changes from Baseline Fractional anisotropy at 3 months

    One of neuroimaging measures

    Time frame: Post 3-month intervention

  19. Changes from Baseline Mean diffusivity at 3 months

    One of neuroimaging measures

    Time frame: Post 3-month intervention

  20. Changes from Baseline Verbal fluency at 3 months

    One of cognitive measures(subtest of CERAD-K)

    Time frame: Post 3-month intervention

  21. Changes from Baseline Boston naming test at 3 months

    One of cognitive measures(subtest of CERAD-K)

    Time frame: Post 3-month intervention

  22. Changes from Baseline Mini-mental status examination at 3 months

    One of cognitive measures(subtest of CERAD-K)

    Time frame: Post 3-month intervention

  23. Changes from Baseline Word list recall at 3 months

    One of cognitive measures(subtest of CERAD-K)

    Time frame: Post 3-month intervention

  24. Changes from Baseline Word list recognition at 3 months

    One of cognitive measures(subtest of CERAD-K)

    Time frame: Post 3-month intervention

  25. Changes from Baseline Constructional recall at 3 months

    One of cognitive measures(subtest of CERAD-K)

    Time frame: Post 3-month intervention

07

Study locations

1 of 1 sites recruiting
  • St.Vincent's Hospital, the Catholic University of Korea
    Suwon, Korea, Republic of
    • Se-Min Choung · Contact · semin9137@cmcnu.or.kr · 82-31-249-8459
    • Yoo Hyun Um, MD, PHD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05200897
Lead sponsor
Saint Vincent's Hospital, Korea
Responsible party
Yoo Hyun Um (Clinical Assistant Professor, Saint Vincent's Hospital, Korea) — Principal investigator
First posted
Jan 21, 2022
Start date
Nov 3, 2021
Primary completion
Nov 30, 2023 (estimated)
Completion
Nov 30, 2023 (estimated)
Last update
Nov 22, 2023

Study contacts

Yoo Hyun Um
Contact
cherubic712@naver.com
+821063759332
Yoo Hyun Um
principal investigator · St.Vincent's Hospital, College of Medicine, Catholic University of Korea

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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