Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia

N/AUnknownNCT05200897

Saint Vincent's Hospital, Korea60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Insomnia Alzheimer Disease Mild Cognitive Impairment Amyloid

Interventions

Transdermal trigeminal electrical neuromodulation(Cefaly)DEVICE

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

Sex: ALLMin age: 60 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

St.Vincent's Hospital, the Catholic University of Korea

Suwon, South Korea

RECRUITING

Outcomes

Primary Outcomes

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