Clinical trial NCT05200897: Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia
Official title: Safety and Effects of Cefaly on Mild Cognitive Impairment With Insomnia and Exploration of Structural and Functional Connectivity Changes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Alzheimer Disease
Mild Cognitive Impairment
Amyloid
Lead sponsor: Saint Vincent's Hospital, Korea
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 .

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from Baseline Pittsburgh sleep quality index(PSQI) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Insomnia severity index(ISI) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Epworth sleepiness scale(ESS) at 3 months
timeFrame: Post-3 month intervention
measure: Changes from Baseline Total time in bed(TIB) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Total sleep time(TST) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Sleep efficiency(SE) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Proportion of stage 1 sleep(N1, %) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Proportion of stage 2 sleep(N2, %) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Proportion of stage 3 sleep(N3, %) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Proportion of REM sleep(R, %) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline REM sleep latency(REML) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Sleep latency(SL) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Apnea-hypopnea index(AHI) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Limb movement index(LMI) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Periodic limb movement index(PLMI) at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Cortical thickness changes at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Functional connectivity measure at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Fractional anisotropy at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Mean diffusivity at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Verbal fluency at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Boston naming test at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Mini-mental status examination at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Word list recall at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Word list recognition at 3 months
timeFrame: Post 3-month intervention
measure: Changes from Baseline Constructional recall at 3 months
timeFrame: Post 3-month intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St.Vincent's Hospital, the Catholic University of Korea
Study officials:
affiliation: St.Vincent's Hospital, College of Medicine, Catholic University of Korea
name: Yoo Hyun Um
role: PRINCIPAL_INVESTIGATOR
References: