NCT05884112

Brief Summary

Narcolepsy is a chronic brain disorder. The mechanism is the impairment of brain controlling of sleep and wakefulness. The cause of this disease is still unclear, but common symptoms include excessive day time sleepiness, cataplexy, hypnogogic hallucination, sleep paralysis, and sleep disturbance. Because these symptoms are easily confused together in many situations, it is difficult for doctors to make the diagnosis. Therefore, medical treatment for patients is always delayed. According to previous research report, narcoleptic patients are often delay diagnosis for 10 to 15 years after the onset of the disease. Clearly, to make the diagnosis of narcolepsy is very difficult. Another cause for the delay is the method for diagnosing narcolepsy, which mainly rely on sleep examination instruments and the testing of hypocretin concentration in the cerebrospinal fluid. However, these tests are difficult to carry out in many areas, and diagnosing narcolepsy is still difficult in many countries. To the patients and their families, developing a fast and accurate method or tool for diagnosing narcolepsy is of the utmost importance.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 1, 2023

Status Verified

April 1, 2023

Enrollment Period

2.3 years

First QC Date

May 9, 2023

Last Update Submit

May 30, 2023

Conditions

Narcolepsy

Keywords

hypersomnianarcolepsydepressiontranscranial magnetic stimulationneurocognitive functionquality of life

Outcome Measures

Primary Outcomes (2)

  • Beck Depression Inventory

    he Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Below 10 points are non-depressed, 10-18 are mild depression, 19-29 are moderate depression, 30-63 are severe depression.

    Screening and following up to six months.

  • The Beck Anxiety Inventory

    a 21-question method developed by Aaron T. Beck. A multiple-choice self-administered scale designed to measure levels of clinical anxiety that can be used to measure anxiety severity. Takes 5 to 10 minutes to complete. Each answer is scored on a scale of 0 (not at all) to 3 (serious). A higher total score indicates more severe anxiety symptoms. Normalized cut-off values are: 0-7: minimal; 8-15: mild; 16-25: Moderate.

    Screening and following up to six months.

Secondary Outcomes (17)

  • Polysomnography -SE

    Screening and following up to six months.

  • Polysomnography -TST

    Screening and following up to six months.

  • Polysomnography -WASO

    Screening and following up to six months.

  • Polysomnography -REM

    Screening and following up to six months.

  • Polysomnography -SL

    Screening and following up to six months.

  • +12 more secondary outcomes

Study Arms (2)

Narcolepsy (type1 +type 2) with depression

EXPERIMENTAL

Stimulate with Double 70mm Alpha Coil figure of 8 stimulator (8-shaped stimulator) (Magstim Company, UK, high frequency magnetic stimulator with force power booster), each treatment will give subjects 1800 pulses, including 60 TBS Section stimulation, each section has 2 seconds of stimulation (30 pulses) and 8 seconds of interval, a total stimulation time of 10 minutes.

Device: "MAGSTIM" reprtitive Transcranial Magnetic Stimulator (rTMS) System

Narcolepsy with depression

SHAM COMPARATOR

Sham-control

Device: sham control

Interventions

"MAGSTIM" reprtitive Transcranial Magnetic Stimulator (rTMS) SystemDEVICE

iTBS is a new treatment method for depression. It uses the principle of magnetoelectricity to intermittently stimulate local brain nerves. In recent years, domestic and foreign studies have confirmed its efficacy and safety for depression. In addition, research has also It shows that iTBS has better therapeutic effect and efficiency than the previous regular rTMS.

Narcolepsy (type1 +type 2) with depression
sham controlDEVICE

sham control

Narcolepsy with depression

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meet the diagnosis of Type 1 or Type 2 sleep disorder, and comorbid with depression.
  • The age is introduced between 18-60 years old, regardless of gender.
  • Those who agree to participate in the trial and sign the subject's consent form.

You may not qualify if:

  • Combined with epilepsy, brain injury or severe organic brain disease or serious heart disease.
  • Combined with serious other mental disorders, such as bipolar disorder, mental retardation or addiction disorders.
  • Not willing to participate in this study or not willing to fill out the consent form.
  • Those who are not suitable to enter the experiment after being evaluated by PI and co PI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang-Gung Memorial Hospital

Taoyuan District, 333423, Taiwan

RECRUITING

Related Publications (28)

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    PMID: 26707042BACKGROUND

  • Blouin AM, Thannickal TC, Worley PF, Baraban JM, Reti IM, Siegel JM. Narp immunostaining of human hypocretin (orexin) neurons: loss in narcolepsy. Neurology. 2005 Oct 25;65(8):1189-92. doi: 10.1212/01.wnl.0000175219.01544.c8. Epub 2005 Aug 31.

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    PMID: 12457441BACKGROUND

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    PMID: 11994752BACKGROUND

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    PMID: 17292770BACKGROUND

  • Nardone R, Bergmann J, Lochner P, Caleri F, Kunz A, Staffen W, Tezzon F, Ladurner G, Trinka E, Golaszewski S. Modafinil reverses hypoexcitability of the motor cortex in narcoleptic patients: a TMS study. Sleep Med. 2010 Oct;11(9):870-5. doi: 10.1016/j.sleep.2010.05.007.

    PMID: 20810311BACKGROUND

  • Huang YS, Liu FY, Lin CY, Hsiao IT, Guilleminault C. Brain imaging and cognition in young narcoleptic patients. Sleep Med. 2016 Aug;24:137-144. doi: 10.1016/j.sleep.2015.11.023. Epub 2016 Jan 19.

    PMID: 27663355BACKGROUND

  • Huang YS, Hsiao IT, Liu FY, Hwang FM, Lin KL, Huang WC, Guilleminault C. Neurocognition, sleep, and PET findings in type 2 vs type 1 narcolepsy. Neurology. 2018 Apr 24;90(17):e1478-e1487. doi: 10.1212/WNL.0000000000005346. Epub 2018 Mar 30.

    PMID: 29602910BACKGROUND

  • Nishino S, Ripley B, Overeem S, Lammers GJ, Mignot E. Hypocretin (orexin) deficiency in human narcolepsy. Lancet. 2000 Jan 1;355(9197):39-40. doi: 10.1016/S0140-6736(99)05582-8.

    PMID: 10615891BACKGROUND

  • Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.

    PMID: 1798888BACKGROUND

  • Kales A, Cadieux RJ, Soldatos CR, Bixler EO, Schweitzer PK, Prey WT, Vela-Bueno A. Narcolepsy-cataplexy. I. Clinical and electrophysiologic characteristics. Arch Neurol. 1982 Mar;39(3):164-8. doi: 10.1001/archneur.1982.00510150034008.

    PMID: 7065934BACKGROUND

  • Kedzior KK, Gierke L, Gellersen HM, Berlim MT. Cognitive functioning and deep transcranial magnetic stimulation (DTMS) in major psychiatric disorders: A systematic review. J Psychiatr Res. 2016 Apr;75:107-15. doi: 10.1016/j.jpsychires.2015.12.019. Epub 2015 Dec 22.

    PMID: 26828370BACKGROUND

  • Lee SA, Kim MK. Effect of Low Frequency Repetitive Transcranial Magnetic Stimulation on Depression and Cognition of Patients with Traumatic Brain Injury: A Randomized Controlled Trial. Med Sci Monit. 2018 Dec 4;24:8789-8794. doi: 10.12659/MSM.911385.

    PMID: 30513530BACKGROUND

  • Li CT, Cheng CM, Chen MH, Juan CH, Tu PC, Bai YM, Jeng JS, Lin WC, Tsai SJ, Su TP. Antidepressant Efficacy of Prolonged Intermittent Theta Burst Stimulation Monotherapy for Recurrent Depression and Comparison of Methods for Coil Positioning: A Randomized, Double-Blind, Sham-Controlled Study. Biol Psychiatry. 2020 Mar 1;87(5):443-450. doi: 10.1016/j.biopsych.2019.07.031. Epub 2019 Aug 9.

    PMID: 31563272BACKGROUND

  • Mignot E, Hayduk R, Black J, Grumet FC, Guilleminault C. HLA DQB1*0602 is associated with cataplexy in 509 narcoleptic patients. Sleep. 1997 Nov;20(11):1012-20.

    PMID: 9456467BACKGROUND

  • Lai JB, Han MM, Xu Y, Hu SH. Effective treatment of narcolepsy-like symptoms with high-frequency repetitive transcranial magnetic stimulation: A case report. Medicine (Baltimore). 2017 Nov;96(46):e8645. doi: 10.1097/MD.0000000000008645.

    PMID: 29145290BACKGROUND

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    PMID: 14757984BACKGROUND

  • Ohayon MM. Narcolepsy is complicated by high medical and psychiatric comorbidities: a comparison with the general population. Sleep Med. 2013 Jun;14(6):488-92. doi: 10.1016/j.sleep.2013.03.002. Epub 2013 May 3.

    PMID: 23643648BACKGROUND

  • Ohayon MM, Priest RG, Caulet M, Guilleminault C. Hypnagogic and hypnopompic hallucinations: pathological phenomena? Br J Psychiatry. 1996 Oct;169(4):459-67. doi: 10.1192/bjp.169.4.459.

    PMID: 8894197BACKGROUND

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    PMID: 2183676BACKGROUND

  • Sonmez AI, Kucuker MU, Lewis CP, Kolla BP, Doruk Camsari D, Vande Voort JL, Schak KM, Kung S, Croarkin PE. Improvement in hypersomnia with high frequency repetitive transcranial magnetic stimulation in depressed adolescents: Preliminary evidence from an open-label study. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Mar 8;97:109763. doi: 10.1016/j.pnpbp.2019.109763. Epub 2019 Oct 18.

    PMID: 31634515BACKGROUND

  • Tsai PS, Wang SY, Wang MY, Su CT, Yang TT, Huang CJ, Fang SC. Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control subjects. Qual Life Res. 2005 Oct;14(8):1943-52. doi: 10.1007/s11136-005-4346-x.

    PMID: 16155782BACKGROUND

  • Vijayakumari AA, Khan FR, Varma RP, Radhakrishnan A. Can transcranial magnetic stimulation be used to evaluate patients with narcolepsy? Neurol Sci. 2013 Aug;34(8):1411-20. doi: 10.1007/s10072-012-1253-0. Epub 2012 Nov 29.

    PMID: 23192441BACKGROUND

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    PMID: 20132530BACKGROUND

MeSH Terms

Conditions

NarcolepsyDisorders of Excessive SomnolenceDepression

Interventions

Transcranial Magnetic StimulationDrug Delivery Systems

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsDrug Therapy

Study Officials

  • Yu-Shu Huang, PhD

    Principal Investigator

    STUDY DIRECTOR

Central Study Contacts

Yu-shu Huang

CONTACT

+886 3 3281200yushuhuang1212@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
participant and doctor
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

June 1, 2023

Study Start

February 22, 2023

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

June 1, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)