- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05884112
Treating Comorbid Depression of Patients With Narcolepsy by Intermittent Theta Burst Stimulation
Treating Comorbid Depression of Patients With Narcolepsy by Intermittent Theta Burst Stimulation: A Preliminary Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yu-shu Huang
- Phone Number: 8539 +886 3 3281200
- Email: yushuhuang1212@gmail.com
Study Locations
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Taoyuan, Taiwan, 333423
- Recruiting
- Chang-Gung Memorial Hospital
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Contact:
- Yu-shu Huang, MD.PhD.
- Phone Number: 8639 +886 3 328200
- Email: yushuhuang1212@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Narcolepsy (type1 +type 2) with depression
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.
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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.
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Sham Comparator: Narcolepsy with depression
Sham-control
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sham control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory
Time Frame: Screening and following up to six months.
|
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.
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Screening and following up to six months.
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The Beck Anxiety Inventory
Time Frame: Screening and following up to six months.
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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.
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Screening and following up to six months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Polysomnography -SE
Time Frame: Screening and following up to six months.
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Change in sleep efficiency (SE, %)based on PSG during the study.
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Screening and following up to six months.
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Polysomnography -TST
Time Frame: Screening and following up to six months.
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Change in total sleep time (TST, mins) based on PSG during the study.
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Screening and following up to six months.
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Polysomnography -WASO
Time Frame: Screening and following up to six months.
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Change in slow wave sleep (SWS, %) based on PSG during the study.
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Screening and following up to six months.
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Polysomnography -REM
Time Frame: Screening and following up to six months.
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Change in REM sleep (%) based on PSG during the study.
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Screening and following up to six months.
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Polysomnography -SL
Time Frame: Screening and following up to six months.
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Change in sleep latency (SL, mins) based on PSG during the study.
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Screening and following up to six months.
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Polysomnography -SWS
Time Frame: Screening and following up to six months.
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Change in slow wave sleep (SWS, %) based on PSG during the study.
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Screening and following up to six months.
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Multiple sleep latency test
Time Frame: Screening and following up to six months.
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Change in Change in sleep latency (SL, mins) based on MSLT during the study.
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Screening and following up to six months.
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Conners' Continuous Performance Test
Time Frame: Screening and following up to six months.
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The Conners Continuous Performance Test is a computer administered test that is designed to assess problems with attention.Many statistics are computed including omission errors , commission errors, hit reaction time, hit reaction time standard error, detectability, response style, perseverations , hit reaction time by block, standard error by block, reaction time by ISI , and standard error by ISI.
These statistics are converted to T-scores and can be interpreted in terms of various aspects of attention including inattention, impulsivity, and vigilance.Higher rates of correct detections indicate better attentional capacity.
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Screening and following up to six months.
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Wisconsin Card Sorting Test
Time Frame: Screening and following up to six months.
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The Wisconsin Card Sorting Test (WCST) is a neuropsychological test that is frequently used to measure such higher-level cognitive processes as attention, perseverance,working memory, abstract thinking and set shifting.
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Screening and following up to six months.
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Epworth Sleepoiness Scale
Time Frame: Screening and following up to six months.
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Epworth Sleepoiness Scale (ESS) assesses the responder's propensity to doze or fall asleep during 8 common daily activities, such as: sitting and reading; sitting inactive in a public place; sitting and talking to someone; sitting quietly after a lunch without alcohol; or in a car, while stopped for a few minutes in traffic.
An ESS score >10 suggests excessive daytime sleepiness (EDS); ESS score ≥16 suggests a high level of EDS.
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Screening and following up to six months.
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Short Form-36
Time Frame: Screening and following up to six months.
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36-Item Short-Form Health Survey (SF-36) includes 11 major questions that evaluate eight components (0-100), with higher scores indicating better outcome.These components include physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional wellbeing, social functioning, pain, and general health.
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Screening and following up to six months.
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PET/MRI
Time Frame: Screening and following up to six months.
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To explore the improvement and difference of narcolepsy and depression symptoms in patients with narcolepsy comorbid depression after rTMS treatment, and to explore the pathological and physiological mechanisms.
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Screening and following up to six months.
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Actigraphy-WASO
Time Frame: Screening and following up to six months.
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Wake after sleep onset (WASO) based on actigraphy during the study.
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Screening and following up to six months.
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Actigraphy-SE
Time Frame: Screening and following up to six months.
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Sleep efficiency (SE, %) based on actigraphy during the study.
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Screening and following up to six months.
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Actigraphy-TST
Time Frame: Screening and following up to six months.
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Total sleep time (TST, mins) based on actigraphy during the study.
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Screening and following up to six months.
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Pittsburgh Sleep Quality Index
Time Frame: Screening and following up to six months.
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Nine main questions assess eight sleep components. Assessments included subjective sleep quality, time to sleep, sleep duration, sleep efficiency, sleep disturbances, use of sleeping pills, daytime dysfunction, and global Pittsburgh Sleep Quality Index scores, with higher scores indicating poorer sleep quality. Each indicator is scored between 0 and 3. The final composite score is made up of seven combined scores, with a total score ranging from 0 to 21, with lower scores representing healthier sleep quality. |
Screening and following up to six months.
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Visual Analogue Scale
Time Frame: Screening and following up to six months.
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Assess the changes in each follow-up of daytime sleepiness and cataplexy symptoms, and the higher the score, the more severe the daytime sleepiness or cataplexy. no (0-4 mm), mild (5-44 mm), moderate (45-74 mm), and severe (75-100 mm) |
Screening and following up to six months.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yu-Shu Huang, PhD, Principal Investigator
Publications and helpful links
General Publications
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- Corbetta M, Shulman GL. Control of goal-directed and stimulus-driven attention in the brain. Nat Rev Neurosci. 2002 Mar;3(3):201-15. doi: 10.1038/nrn755.
- 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.
- Barbey AK, Koenigs M, Grafman J. Dorsolateral prefrontal contributions to human working memory. Cortex. 2013 May;49(5):1195-205. doi: 10.1016/j.cortex.2012.05.022. Epub 2012 Jun 16.
- Dauvilliers Y, Arnulf I, Mignot E. Narcolepsy with cataplexy. Lancet. 2007 Feb 10;369(9560):499-511. doi: 10.1016/S0140-6736(07)60237-2.
- 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.
- Posner MI, Petersen SE. The attention system of the human brain. Annu Rev Neurosci. 1990;13:25-42. doi: 10.1146/annurev.ne.13.030190.000325. No abstract available.
- Arand D, Bonnet M, Hurwitz T, Mitler M, Rosa R, Sangal RB. The clinical use of the MSLT and MWT. Sleep. 2005 Jan;28(1):123-44. doi: 10.1093/sleep/28.1.123.
- Buskova J, Kemlink D, Ibarburu V, Nevsimalova S, Sonka K. Antidepressants substantially affect basic REM sleep characteristics in narcolepsy-cataplexy patients. Neuro Endocrinol Lett. 2015;36(5):430-3.
- 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.
- Brooks S, Black J. Novel therapies for narcolepsy. Expert Opin Investig Drugs. 2002 Dec;11(12):1821-7. doi: 10.1517/13543784.11.12.1821.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Naumann A, Daum I. Narcolepsy: pathophysiology and neuropsychological changes. Behav Neurol. 2003;14(3-4):89-98. doi: 10.1155/2003/323060.
- 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.
- 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.
- 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.
- 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.
- Wang W, Chair SY, Thompson DR, Twinn SF. A psychometric evaluation of the Chinese version of the Hospital Anxiety and Depression Scale in patients with coronary heart disease. J Clin Nurs. 2009 Jul;18(13):1908-15. doi: 10.1111/j.1365-2702.2008.02736.x.
- Yang CM, Huang YS, Song YC. Clinical utility of the Chinese version of the Pediatric Daytime Sleepiness Scale in children with obstructive sleep apnea syndrome and narcolepsy. Psychiatry Clin Neurosci. 2010 Apr;64(2):134-40. doi: 10.1111/j.1440-1819.2009.02054.x. Epub 2010 Feb 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202102036A3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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