Transdermal electrical stimulation for mild cognitive impairment with insomnia
Safety and Effects of Cefaly on Mild Cognitive Impairment With Insomnia and Exploration of Structural and Functional Connectivity Changes
This study is testing if a new electrical treatment can help people with mild cognitive impairment and insomnia feel better and improve their sleep over three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | Saint Vincent's Hospital, Korea Academic / other |
| Locations | 1 site (Suwon) |
| Trial ID | NCT05200897 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the safety and effectiveness of transdermal trigeminal electrical neuromodulation (Cefaly) in patients with mild cognitive impairment who also suffer from insomnia. The intervention will last for three months, during which participants will undergo assessments of brain functional and structural connectivity, as well as sleep parameters measured through polysomnography and sleep surveys. The study will also consider factors such as amyloid positivity and brain-derived neurotrophic factor levels. Both baseline and post-intervention data will be collected to evaluate the impact of the treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with mild cognitive impairment, amyloid positive, and experiencing significant insomnia.
Not a fit: Patients with active psychiatric or neurological disorders, unstable medical conditions, or severe obstructive sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve sleep quality and cognitive function in patients with mild cognitive impairment and insomnia.
How similar studies have performed: While the approach is innovative, similar studies exploring neuromodulation for cognitive and sleep disorders have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Suwon
- St.Vincent's Hospital, the Catholic University of Korea — Suwon, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Yoo Hyun Um — St.Vincent's Hospital, College of Medicine, Catholic University of Korea
- Study coordinator: Yoo Hyun Um
- Email: cherubic712@naver.com
- Phone: +821063759332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.