Safety and Effects of Cefaly on Mild Cognitive Impairment With Insomnia and Exploration of Structural and Functional Connectivity Changes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes from Baseline Proportion of stage 2 sleep(N2, %) at 3 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 85 Years (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
Amyloid positive mild cognitive impairment+ BDNF met carrier
Transdermal trigeminal electrical modulation for 3 months
Intervention: Transdermal trigeminal electrical neuromodulation(Cefaly) (Device)
Amyloid positive mild cognitive impairment+ BDNF Val/Val
Transdermal trigeminal electrical modulation for 3 months
Intervention: Transdermal trigeminal electrical neuromodulation(Cefaly) (Device)
Amyloid negative mild cognitive impairment+ BDNF met carrier
Transdermal trigeminal electrical modulation for 3 months
Intervention: Transdermal trigeminal electrical neuromodulation(Cefaly) (Device)
Amyloid negative mild cognitive impairment+ BDNF Val/Val
Transdermal trigeminal electrical modulation for 3 months
Intervention: Transdermal trigeminal electrical neuromodulation(Cefaly) (Device)
Outcomes
Primary Outcomes
Changes from Baseline Proportion of stage 2 sleep(N2, %) at 3 months
Time Frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Verbal fluency at 3 months
Time Frame: Post 3-month intervention
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Pittsburgh sleep quality index(PSQI) at 3 months
Time Frame: Post 3-month intervention
PSQI global score of more than 5 signifies major sleep disturbance, higher scores suggesting greater sleep disturbance
Changes from Baseline Proportion of stage 1 sleep(N1, %) at 3 months
Time Frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Insomnia severity index(ISI) at 3 months
Time Frame: Post 3-month intervention
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
Changes from Baseline Sleep efficiency(SE) at 3 months
Time Frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Proportion of stage 3 sleep(N3, %) at 3 months
Time Frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Proportion of REM sleep(R, %) at 3 months
Time Frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline REM sleep latency(REML) at 3 months
Time Frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Sleep latency(SL) at 3 months
Time Frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Apnea-hypopnea index(AHI) at 3 months
Time Frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Total sleep time(TST) at 3 months
Time Frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Limb movement index(LMI) at 3 months
Time Frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Boston naming test at 3 months
Time Frame: Post 3-month intervention
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Functional connectivity measure at 3 months
Time Frame: Post 3-month intervention
One of neuroimaging measures
Changes from Baseline Epworth sleepiness scale(ESS) at 3 months
Time Frame: Post-3 month intervention
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.
Changes from Baseline Total time in bed(TIB) at 3 months
Time Frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Cortical thickness changes at 3 months
Time Frame: Post 3-month intervention
One of neuroimaging measures
Changes from Baseline Fractional anisotropy at 3 months
Time Frame: Post 3-month intervention
One of neuroimaging measures
Changes from Baseline Mean diffusivity at 3 months
Time Frame: Post 3-month intervention
One of neuroimaging measures
Changes from Baseline Periodic limb movement index(PLMI) at 3 months
Time Frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Mini-mental status examination at 3 months
Time Frame: Post 3-month intervention
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Word list recall at 3 months
Time Frame: Post 3-month intervention
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Word list recognition at 3 months
Time Frame: Post 3-month intervention
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Constructional recall at 3 months
Time Frame: Post 3-month intervention
One of cognitive measures(subtest of CERAD-K)
Secondary Outcomes
No secondary outcomes reported
Investigators
Yoo Hyun Um
Clinical Assistant Professor
Saint Vincent's Hospital, Korea