Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia
Safety and Effects of Cefaly on Mild Cognitive Impairment With Insomnia and Exploration of Structural and Functional Connectivity Changes
1 other identifier
interventional
60
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 3, 2021
CompletedFirst Submitted
Initial submission to the registry
December 5, 2021
CompletedFirst Posted
Study publicly available on registry
January 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedNovember 22, 2023
November 1, 2023
2.1 years
December 5, 2021
November 20, 2023
Conditions
Outcome Measures
Primary Outcomes (25)
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
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
Study Arms (4)
Amyloid positive mild cognitive impairment+ BDNF met carrier
EXPERIMENTALTransdermal trigeminal electrical modulation for 3 months
Amyloid positive mild cognitive impairment+ BDNF Val/Val
EXPERIMENTALTransdermal trigeminal electrical modulation for 3 months
Amyloid negative mild cognitive impairment+ BDNF met carrier
EXPERIMENTALTransdermal trigeminal electrical modulation for 3 months
Amyloid negative mild cognitive impairment+ BDNF Val/Val
EXPERIMENTALTransdermal trigeminal electrical modulation for 3 months
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St.Vincent's Hospital, the Catholic University of Korea
Suwon, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoo Hyun Um
St.Vincent's Hospital, College of Medicine, Catholic University of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
December 5, 2021
First Posted
January 21, 2022
Study Start
November 3, 2021
Primary Completion
November 30, 2023
Study Completion
November 30, 2023
Last Updated
November 22, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share