Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200897
• Other study ID #: VC21DNSI0029
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: November 2023
• Source: Saint Vincent's Hospital, Korea
• Contact: Yoo Hyun Um
• Phone: +821063759332
• Email: cherubic712[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Amyloid
• Cognitive Dysfunction
• Insomnia
• Mild Cognitive Impairment
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	St.Vincent's Hospital, the Catholic University of Korea	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Saint Vincent's Hospital, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Changes from Baseline Total time in bed(TIB) at 3 months	One of polysomnography measures	Post 3-month intervention
Primary	Changes from Baseline Total sleep time(TST) at 3 months	One of polysomnography measures	Post 3-month intervention
Primary	Changes from Baseline Sleep efficiency(SE) at 3 months	One of polysomnography measures	Post 3-month intervention
Primary	Changes from Baseline Proportion of stage 1 sleep(N1, %) at 3 months	One of polysomnography measures	Post 3-month intervention
Primary	Changes from Baseline Proportion of stage 2 sleep(N2, %) at 3 months	One of polysomnography measures	Post 3-month intervention
Primary	Changes from Baseline Proportion of stage 3 sleep(N3, %) at 3 months	One of polysomnography measures	Post 3-month intervention
Primary	Changes from Baseline Proportion of REM sleep(R, %) at 3 months	One of polysomnography measures	Post 3-month intervention
Primary	Changes from Baseline REM sleep latency(REML) at 3 months	One of polysomnography measures	Post 3-month intervention
Primary	Changes from Baseline Sleep latency(SL) at 3 months	One of polysomnography measures	Post 3-month intervention
Primary	Changes from Baseline Apnea-hypopnea index(AHI) at 3 months	One of polysomnography measures	Post 3-month intervention
Primary	Changes from Baseline Limb movement index(LMI) at 3 months	One of polysomnography measures	Post 3-month intervention
Primary	Changes from Baseline Periodic limb movement index(PLMI) at 3 months	One of polysomnography measures	Post 3-month intervention
Primary	Changes from Baseline Cortical thickness changes at 3 months	One of neuroimaging measures	Post 3-month intervention
Primary	Changes from Baseline Functional connectivity measure at 3 months	One of neuroimaging measures	Post 3-month intervention
Primary	Changes from Baseline Fractional anisotropy at 3 months	One of neuroimaging measures	Post 3-month intervention
Primary	Changes from Baseline Mean diffusivity at 3 months	One of neuroimaging measures	Post 3-month intervention
Primary	Changes from Baseline Verbal fluency at 3 months	One of cognitive measures(subtest of CERAD-K)	Post 3-month intervention
Primary	Changes from Baseline Boston naming test at 3 months	One of cognitive measures(subtest of CERAD-K)	Post 3-month intervention
Primary	Changes from Baseline Mini-mental status examination at 3 months	One of cognitive measures(subtest of CERAD-K)	Post 3-month intervention
Primary	Changes from Baseline Word list recall at 3 months	One of cognitive measures(subtest of CERAD-K)	Post 3-month intervention
Primary	Changes from Baseline Word list recognition at 3 months	One of cognitive measures(subtest of CERAD-K)	Post 3-month intervention
Primary	Changes from Baseline Constructional recall at 3 months	One of cognitive measures(subtest of CERAD-K)	Post 3-month intervention