Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia
NCT ID: NCT05200897
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2021-11-03
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Amyloid positive mild cognitive impairment+ BDNF met carrier
Transdermal trigeminal electrical modulation for 3 months
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
Amyloid positive mild cognitive impairment+ BDNF Val/Val
Transdermal trigeminal electrical modulation for 3 months
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
Amyloid negative mild cognitive impairment+ BDNF met carrier
Transdermal trigeminal electrical modulation for 3 months
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
Amyloid negative mild cognitive impairment+ BDNF Val/Val
Transdermal trigeminal electrical modulation for 3 months
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
Interventions
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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
Eligibility Criteria
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Inclusion 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
* 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
60 Years
85 Years
ALL
No
Sponsors
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Saint Vincent's Hospital, Korea
OTHER
Responsible Party
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Yoo Hyun Um
Clinical Assistant Professor
Principal Investigators
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Yoo Hyun Um
Role: PRINCIPAL_INVESTIGATOR
St.Vincent's Hospital, College of Medicine, Catholic University of Korea
Locations
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St.Vincent's Hospital, the Catholic University of Korea
Suwon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VC21DNSI0029
Identifier Type: -
Identifier Source: org_study_id