Status:
UNKNOWN
Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia
Lead Sponsor:
Saint Vincent's Hospital, Korea
Conditions:
Insomnia
Alzheimer Disease
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief 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 co...
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05200897
Start Date
November 3 2021
End Date
November 30 2023
Last Update
November 22 2023
Active Locations (1)
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1
St.Vincent's Hospital, the Catholic University of Korea
Suwon, South Korea