Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia

Saint Vincent's Hospital, Korea

Status: Enrolling

Conditions: Amyloid; Alzheimer Disease; Mild Cognitive Impairment; Insomnia

Treatments: Device: Transdermal trigeminal electrical neuromodulation(Cefaly)

Study type: Interventional

Funder types: Other

Identifiers

NCT05200897

VC21DNSI0029

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Amyloid positive mild cognitive impairment+ BDNF met carrier

Experimental group

Description:

Transdermal trigeminal electrical modulation for 3 months

Treatment:

Device: Transdermal trigeminal electrical neuromodulation(Cefaly)

Amyloid positive mild cognitive impairment+ BDNF Val/Val

Experimental group

Description:

Transdermal trigeminal electrical modulation for 3 months

Treatment:

Device: Transdermal trigeminal electrical neuromodulation(Cefaly)

Amyloid negative mild cognitive impairment+ BDNF met carrier

Experimental group

Description:

Transdermal trigeminal electrical modulation for 3 months

Treatment:

Device: Transdermal trigeminal electrical neuromodulation(Cefaly)

Amyloid negative mild cognitive impairment+ BDNF Val/Val

Experimental group

Description:

Transdermal trigeminal electrical modulation for 3 months

Treatment:

Device: Transdermal trigeminal electrical neuromodulation(Cefaly)