Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia

Sponsor

Saint Vincent's Hospital, Korea (Other)

Overall Status

Recruiting

CT.gov ID

NCT05200897

Collaborator

(none)

Enrollment

Location

Arms

18.9

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Insomnia Alzheimer Disease Mild Cognitive Impairment Amyloid	Device: Transdermal trigeminal electrical neuromodulation(Cefaly)	N/A

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

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Safety and Effects of Cefaly on Mild Cognitive Impairment With Insomnia and Exploration of Structural and Functional Connectivity Changes

Actual Study Start Date :

Nov 3, 2021

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amyloid positive mild cognitive impairment+ BDNF met carrier Transdermal trigeminal electrical modulation for 3 months	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
Experimental: Amyloid positive mild cognitive impairment+ BDNF Val/Val Transdermal trigeminal electrical modulation for 3 months	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
Experimental: Amyloid negative mild cognitive impairment+ BDNF met carrier Transdermal trigeminal electrical modulation for 3 months	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
Experimental: Amyloid negative mild cognitive impairment+ BDNF Val/Val Transdermal trigeminal electrical modulation for 3 months	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

Outcome Measures

Primary Outcome Measures

Changes from Baseline Pittsburgh sleep quality index(PSQI) at 3 months [Post 3-month intervention]
PSQI global score of more than 5 signifies major sleep disturbance, higher scores suggesting greater sleep disturbance
Changes from Baseline Insomnia severity index(ISI) at 3 months [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 Epworth sleepiness scale(ESS) at 3 months [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 [Post 3-month intervention]
One of polysomnography measures
Changes from Baseline Total sleep time(TST) at 3 months [Post 3-month intervention]
One of polysomnography measures
Changes from Baseline Sleep efficiency(SE) at 3 months [Post 3-month intervention]
One of polysomnography measures
Changes from Baseline Proportion of stage 1 sleep(N1, %) at 3 months [Post 3-month intervention]
One of polysomnography measures
Changes from Baseline Proportion of stage 2 sleep(N2, %) at 3 months [Post 3-month intervention]
One of polysomnography measures
Changes from Baseline Proportion of stage 3 sleep(N3, %) at 3 months [Post 3-month intervention]
One of polysomnography measures
Changes from Baseline Proportion of REM sleep(R, %) at 3 months [Post 3-month intervention]
One of polysomnography measures
Changes from Baseline REM sleep latency(REML) at 3 months [Post 3-month intervention]
One of polysomnography measures
Changes from Baseline Sleep latency(SL) at 3 months [Post 3-month intervention]
One of polysomnography measures
Changes from Baseline Apnea-hypopnea index(AHI) at 3 months [Post 3-month intervention]
One of polysomnography measures
Changes from Baseline Limb movement index(LMI) at 3 months [Post 3-month intervention]
One of polysomnography measures
Changes from Baseline Periodic limb movement index(PLMI) at 3 months [Post 3-month intervention]
One of polysomnography measures
Changes from Baseline Cortical thickness changes at 3 months [Post 3-month intervention]
One of neuroimaging measures
Changes from Baseline Functional connectivity measure at 3 months [Post 3-month intervention]
One of neuroimaging measures
Changes from Baseline Fractional anisotropy at 3 months [Post 3-month intervention]
One of neuroimaging measures
Changes from Baseline Mean diffusivity at 3 months [Post 3-month intervention]
One of neuroimaging measures
Changes from Baseline Verbal fluency at 3 months [Post 3-month intervention]
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Boston naming test at 3 months [Post 3-month intervention]
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Mini-mental status examination at 3 months [Post 3-month intervention]
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Word list recall at 3 months [Post 3-month intervention]
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Word list recognition at 3 months [Post 3-month intervention]
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Constructional recall at 3 months [Post 3-month intervention]
One of cognitive measures(subtest of CERAD-K)

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St.Vincent's Hospital, the Catholic University of Korea	Suwon		Korea, Republic of

Sponsors and Collaborators

Saint Vincent's Hospital, Korea

Investigators

Principal Investigator: Yoo Hyun Um, St.Vincent's Hospital, College of Medicine, Catholic University of Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yoo Hyun Um, Clinical Assistant Professor, Saint Vincent's Hospital, Korea

ClinicalTrials.gov Identifier:

NCT05200897

Other Study ID Numbers:

VC21DNSI0029

First Posted:

Jan 21, 2022

Last Update Posted:

Jan 21, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Sleep Initiation and Maintenance Disorders

Cognitive Dysfunction

Study Results

No Results Posted as of Jan 21, 2022