Trials / Unknown
UnknownNCT05200897
Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia
Safety and Effects of Cefaly on Mild Cognitive Impairment With Insomnia and Exploration of Structural and Functional Connectivity Changes
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Saint Vincent's Hospital, Korea · Academic / Other
- Sex
- All
- Age
- 60 Years – 85 Years
- Healthy volunteers
- Not accepted
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 .
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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 |
Timeline
- Start date
- 2021-11-03
- Primary completion
- 2023-11-30
- Completion
- 2023-11-30
- First posted
- 2022-01-21
- Last updated
- 2023-11-22
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05200897. Inclusion in this directory is not an endorsement.