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Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia

Primary Purpose

Insomnia, Alzheimer Disease, Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transdermal trigeminal electrical neuromodulation(Cefaly)
Sponsored by
Saint Vincent's Hospital, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insomnia

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St.Vincent's Hospital, the Catholic University of KoreaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Amyloid positive mild cognitive impairment+ BDNF met carrier

Amyloid positive mild cognitive impairment+ BDNF Val/Val

Amyloid negative mild cognitive impairment+ BDNF met carrier

Amyloid negative mild cognitive impairment+ BDNF Val/Val

Arm Description

Transdermal trigeminal electrical modulation for 3 months

Transdermal trigeminal electrical modulation for 3 months

Transdermal trigeminal electrical modulation for 3 months

Transdermal trigeminal electrical modulation for 3 months

Outcomes

Primary Outcome Measures

Changes from Baseline Pittsburgh sleep quality index(PSQI) at 3 months
PSQI global score of more than 5 signifies major sleep disturbance, higher scores suggesting greater sleep disturbance
Changes from Baseline Insomnia severity index(ISI) at 3 months
ISI is a brief, self-rated scale that is widely used to measure insomnia severity. With seven items scored on a 0-4 scale, it only takes about 5 minutes to complete and scores of 15 or more indicates insomnia of moderate to severe severity
Changes from Baseline Epworth sleepiness scale(ESS) at 3 months
ESS is a self-administered scale with eight questionnaires measuring sleepiness in daily life. Score of more than 10 signifies clinically meaningful daytime sleepiness, with higher scores indicating more severe sleepiness.
Changes from Baseline Total time in bed(TIB) at 3 months
One of polysomnography measures
Changes from Baseline Total sleep time(TST) at 3 months
One of polysomnography measures
Changes from Baseline Sleep efficiency(SE) at 3 months
One of polysomnography measures
Changes from Baseline Proportion of stage 1 sleep(N1, %) at 3 months
One of polysomnography measures
Changes from Baseline Proportion of stage 2 sleep(N2, %) at 3 months
One of polysomnography measures
Changes from Baseline Proportion of stage 3 sleep(N3, %) at 3 months
One of polysomnography measures
Changes from Baseline Proportion of REM sleep(R, %) at 3 months
One of polysomnography measures
Changes from Baseline REM sleep latency(REML) at 3 months
One of polysomnography measures
Changes from Baseline Sleep latency(SL) at 3 months
One of polysomnography measures
Changes from Baseline Apnea-hypopnea index(AHI) at 3 months
One of polysomnography measures
Changes from Baseline Limb movement index(LMI) at 3 months
One of polysomnography measures
Changes from Baseline Periodic limb movement index(PLMI) at 3 months
One of polysomnography measures
Changes from Baseline Cortical thickness changes at 3 months
One of neuroimaging measures
Changes from Baseline Functional connectivity measure at 3 months
One of neuroimaging measures
Changes from Baseline Fractional anisotropy at 3 months
One of neuroimaging measures
Changes from Baseline Mean diffusivity at 3 months
One of neuroimaging measures
Changes from Baseline Verbal fluency at 3 months
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Boston naming test at 3 months
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Mini-mental status examination at 3 months
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Word list recall at 3 months
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Word list recognition at 3 months
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Constructional recall at 3 months
One of cognitive measures(subtest of CERAD-K)

Secondary Outcome Measures

Full Information

First Posted
December 5, 2021
Last Updated
April 10, 2023
Sponsor
Saint Vincent's Hospital, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT05200897
Brief Title
Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia
Official Title
Safety and Effects of Cefaly on Mild Cognitive Impairment With Insomnia and Exploration of Structural and Functional Connectivity Changes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Vincent's Hospital, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Alzheimer Disease, Mild Cognitive Impairment, Amyloid

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amyloid positive mild cognitive impairment+ BDNF met carrier
Arm Type
Experimental
Arm Description
Transdermal trigeminal electrical modulation for 3 months
Arm Title
Amyloid positive mild cognitive impairment+ BDNF Val/Val
Arm Type
Experimental
Arm Description
Transdermal trigeminal electrical modulation for 3 months
Arm Title
Amyloid negative mild cognitive impairment+ BDNF met carrier
Arm Type
Experimental
Arm Description
Transdermal trigeminal electrical modulation for 3 months
Arm Title
Amyloid negative mild cognitive impairment+ BDNF Val/Val
Arm Type
Experimental
Arm Description
Transdermal trigeminal electrical modulation for 3 months
Intervention Type
Device
Intervention Name(s)
Transdermal trigeminal electrical neuromodulation(Cefaly)
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes from Baseline Pittsburgh sleep quality index(PSQI) at 3 months
Description
PSQI global score of more than 5 signifies major sleep disturbance, higher scores suggesting greater sleep disturbance
Time Frame
Post 3-month intervention
Title
Changes from Baseline Insomnia severity index(ISI) at 3 months
Description
ISI is a brief, self-rated scale that is widely used to measure insomnia severity. With seven items scored on a 0-4 scale, it only takes about 5 minutes to complete and scores of 15 or more indicates insomnia of moderate to severe severity
Time Frame
Post 3-month intervention
Title
Changes from Baseline Epworth sleepiness scale(ESS) at 3 months
Description
ESS is a self-administered scale with eight questionnaires measuring sleepiness in daily life. Score of more than 10 signifies clinically meaningful daytime sleepiness, with higher scores indicating more severe sleepiness.
Time Frame
Post-3 month intervention
Title
Changes from Baseline Total time in bed(TIB) at 3 months
Description
One of polysomnography measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Total sleep time(TST) at 3 months
Description
One of polysomnography measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Sleep efficiency(SE) at 3 months
Description
One of polysomnography measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Proportion of stage 1 sleep(N1, %) at 3 months
Description
One of polysomnography measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Proportion of stage 2 sleep(N2, %) at 3 months
Description
One of polysomnography measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Proportion of stage 3 sleep(N3, %) at 3 months
Description
One of polysomnography measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Proportion of REM sleep(R, %) at 3 months
Description
One of polysomnography measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline REM sleep latency(REML) at 3 months
Description
One of polysomnography measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Sleep latency(SL) at 3 months
Description
One of polysomnography measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Apnea-hypopnea index(AHI) at 3 months
Description
One of polysomnography measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Limb movement index(LMI) at 3 months
Description
One of polysomnography measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Periodic limb movement index(PLMI) at 3 months
Description
One of polysomnography measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Cortical thickness changes at 3 months
Description
One of neuroimaging measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Functional connectivity measure at 3 months
Description
One of neuroimaging measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Fractional anisotropy at 3 months
Description
One of neuroimaging measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Mean diffusivity at 3 months
Description
One of neuroimaging measures
Time Frame
Post 3-month intervention
Title
Changes from Baseline Verbal fluency at 3 months
Description
One of cognitive measures(subtest of CERAD-K)
Time Frame
Post 3-month intervention
Title
Changes from Baseline Boston naming test at 3 months
Description
One of cognitive measures(subtest of CERAD-K)
Time Frame
Post 3-month intervention
Title
Changes from Baseline Mini-mental status examination at 3 months
Description
One of cognitive measures(subtest of CERAD-K)
Time Frame
Post 3-month intervention
Title
Changes from Baseline Word list recall at 3 months
Description
One of cognitive measures(subtest of CERAD-K)
Time Frame
Post 3-month intervention
Title
Changes from Baseline Word list recognition at 3 months
Description
One of cognitive measures(subtest of CERAD-K)
Time Frame
Post 3-month intervention
Title
Changes from Baseline Constructional recall at 3 months
Description
One of cognitive measures(subtest of CERAD-K)
Time Frame
Post 3-month intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoo Hyun Um
Phone
+821063759332
Email
cherubic712@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoo Hyun Um
Organizational Affiliation
St.Vincent's Hospital, College of Medicine, Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
St.Vincent's Hospital, the Catholic University of Korea
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Se-Min Choung
Phone
82-31-249-8459
Email
semin9137@cmcnu.or.kr
First Name & Middle Initial & Last Name & Degree
Yoo Hyun Um, MD, PHD

12. IPD Sharing Statement

Plan to Share IPD
No

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Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia

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