Safety and Effects of Cefaly on Mild Cognitive Impairment With Insomnia and Exploration of Structural and Functional Connectivity Changes
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 .
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
St.Vincent's Hospital, the Catholic University of Korea
RECRUITING
Suwon
Contact Information
Primary
Yoo Hyun Um
cherubic712@naver.com
+821063759332
Time Frame
Start Date: 2021-11-03
Estimated Completion Date: 2023-11-30
Participants
Target number of participants: 60
Treatments
Experimental: Amyloid positive mild cognitive impairment+ BDNF met carrier
Transdermal trigeminal electrical modulation for 3 months
Experimental: Amyloid positive mild cognitive impairment+ BDNF Val/Val
Transdermal trigeminal electrical modulation for 3 months
Experimental: Amyloid negative mild cognitive impairment+ BDNF met carrier
Transdermal trigeminal electrical modulation for 3 months
Experimental: Amyloid negative mild cognitive impairment+ BDNF Val/Val
Transdermal trigeminal electrical modulation for 3 months
Related Therapeutic Areas
Sponsors
Leads: Saint Vincent's Hospital, Korea