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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05200897
Other study ID # VC21DNSI0029
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 3, 2021
Est. completion date November 30, 2023

Study information

Verified date November 2023
Source Saint Vincent's Hospital, Korea
Contact Yoo Hyun Um
Phone +821063759332
Email cherubic712@naver.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transdermal 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

Locations

Country Name City State
Korea, Republic of St.Vincent's Hospital, the Catholic University of Korea Suwon

Sponsors (1)

Lead Sponsor Collaborator
Saint Vincent's Hospital, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Post 3-month intervention
Primary 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 Post 3-month intervention
Primary 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. Post-3 month intervention
Primary Changes from Baseline Total time in bed(TIB) at 3 months One of polysomnography measures Post 3-month intervention
Primary Changes from Baseline Total sleep time(TST) at 3 months One of polysomnography measures Post 3-month intervention
Primary Changes from Baseline Sleep efficiency(SE) at 3 months One of polysomnography measures Post 3-month intervention
Primary Changes from Baseline Proportion of stage 1 sleep(N1, %) at 3 months One of polysomnography measures Post 3-month intervention
Primary Changes from Baseline Proportion of stage 2 sleep(N2, %) at 3 months One of polysomnography measures Post 3-month intervention
Primary Changes from Baseline Proportion of stage 3 sleep(N3, %) at 3 months One of polysomnography measures Post 3-month intervention
Primary Changes from Baseline Proportion of REM sleep(R, %) at 3 months One of polysomnography measures Post 3-month intervention
Primary Changes from Baseline REM sleep latency(REML) at 3 months One of polysomnography measures Post 3-month intervention
Primary Changes from Baseline Sleep latency(SL) at 3 months One of polysomnography measures Post 3-month intervention
Primary Changes from Baseline Apnea-hypopnea index(AHI) at 3 months One of polysomnography measures Post 3-month intervention
Primary Changes from Baseline Limb movement index(LMI) at 3 months One of polysomnography measures Post 3-month intervention
Primary Changes from Baseline Periodic limb movement index(PLMI) at 3 months One of polysomnography measures Post 3-month intervention
Primary Changes from Baseline Cortical thickness changes at 3 months One of neuroimaging measures Post 3-month intervention
Primary Changes from Baseline Functional connectivity measure at 3 months One of neuroimaging measures Post 3-month intervention
Primary Changes from Baseline Fractional anisotropy at 3 months One of neuroimaging measures Post 3-month intervention
Primary Changes from Baseline Mean diffusivity at 3 months One of neuroimaging measures Post 3-month intervention
Primary Changes from Baseline Verbal fluency at 3 months One of cognitive measures(subtest of CERAD-K) Post 3-month intervention
Primary Changes from Baseline Boston naming test at 3 months One of cognitive measures(subtest of CERAD-K) Post 3-month intervention
Primary Changes from Baseline Mini-mental status examination at 3 months One of cognitive measures(subtest of CERAD-K) Post 3-month intervention
Primary Changes from Baseline Word list recall at 3 months One of cognitive measures(subtest of CERAD-K) Post 3-month intervention
Primary Changes from Baseline Word list recognition at 3 months One of cognitive measures(subtest of CERAD-K) Post 3-month intervention
Primary Changes from Baseline Constructional recall at 3 months One of cognitive measures(subtest of CERAD-K) Post 3-month intervention
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