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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amyloid positive mild cognitive impairment+ BDNF met carrier | Experimental | Transdermal trigeminal electrical modulation for 3 months |
|
| Amyloid positive mild cognitive impairment+ BDNF Val/Val | Experimental | Transdermal trigeminal electrical modulation for 3 months |
|
| Amyloid negative mild cognitive impairment+ BDNF met carrier | Experimental | Transdermal trigeminal electrical modulation for 3 months |
|
| Amyloid negative mild cognitive impairment+ BDNF Val/Val | Experimental | Transdermal trigeminal electrical modulation for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal trigeminal electrical neuromodulation(Cefaly) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Changes from Baseline Total time in bed(TIB) at 3 months | One of polysomnography measures | Post 3-month intervention |
| Changes from Baseline Total sleep time(TST) at 3 months | One of polysomnography measures | Post 3-month intervention |
| Changes from Baseline Sleep efficiency(SE) at 3 months | One of polysomnography measures | Post 3-month intervention |
| Changes from Baseline Proportion of stage 1 sleep(N1, %) at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoo Hyun Um | Contact | +821063759332 | cherubic712@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Yoo Hyun Um | St.Vincent's Hospital, College of Medicine, Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Vincent's Hospital, the Catholic University of Korea | Recruiting | Suwon | South Korea |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
One of polysomnography measures |
| Post 3-month intervention |
| Changes from Baseline Proportion of stage 2 sleep(N2, %) at 3 months | One of polysomnography measures | Post 3-month intervention |
| Changes from Baseline Proportion of stage 3 sleep(N3, %) at 3 months | One of polysomnography measures | Post 3-month intervention |
| Changes from Baseline Proportion of REM sleep(R, %) at 3 months | One of polysomnography measures | Post 3-month intervention |
| Changes from Baseline REM sleep latency(REML) at 3 months | One of polysomnography measures | Post 3-month intervention |
| Changes from Baseline Sleep latency(SL) at 3 months | One of polysomnography measures | Post 3-month intervention |
| Changes from Baseline Apnea-hypopnea index(AHI) at 3 months | One of polysomnography measures | Post 3-month intervention |
| Changes from Baseline Limb movement index(LMI) at 3 months | One of polysomnography measures | Post 3-month intervention |
| Changes from Baseline Periodic limb movement index(PLMI) at 3 months | One of polysomnography measures | Post 3-month intervention |
| Changes from Baseline Cortical thickness changes at 3 months | One of neuroimaging measures | Post 3-month intervention |
| Changes from Baseline Functional connectivity measure at 3 months | One of neuroimaging measures | Post 3-month intervention |
| Changes from Baseline Fractional anisotropy at 3 months | One of neuroimaging measures | Post 3-month intervention |
| Changes from Baseline Mean diffusivity at 3 months | One of neuroimaging measures | Post 3-month intervention |
| Changes from Baseline Verbal fluency at 3 months | One of cognitive measures(subtest of CERAD-K) | Post 3-month intervention |
| Changes from Baseline Boston naming test at 3 months | One of cognitive measures(subtest of CERAD-K) | Post 3-month intervention |
| Changes from Baseline Mini-mental status examination at 3 months | One of cognitive measures(subtest of CERAD-K) | Post 3-month intervention |
| Changes from Baseline Word list recall at 3 months | One of cognitive measures(subtest of CERAD-K) | Post 3-month intervention |
| Changes from Baseline Word list recognition at 3 months | One of cognitive measures(subtest of CERAD-K) | Post 3-month intervention |
| Changes from Baseline Constructional recall at 3 months | One of cognitive measures(subtest of CERAD-K) | Post 3-month intervention |
| D001523 |
| Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D003072 | Cognition Disorders |