NarcolepsyNCT05884112
Treating Comorbid Depression of Patients With Narcolepsy by Intermittent Theta Burst Stimulation
A study testing "MAGSTIM" reprtitive Transcranial Magnetic Stimulator (rTMS) System in people with Narcolepsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Narcolepsy
- What is being tested?
- "MAGSTIM" reprtitive Transcranial Magnetic Stimulator (rTMS) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Feb 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang-Gung Memorial Hospital
Taoyuan, 333423
Yu-shu Huang, MD.PhD., +886 3 328200 ext. 8639, yushuhuang1212@gmail.com
About this study
Official title: Treating Comorbid Depression of Patients With Narcolepsy by Intermittent Theta Burst Stimulation: A Preliminary Study
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.
Read the detailed description
The purposes of this study are as follows: (1) To collect comprehensive narcolepsy and non-narcolepsy brain imaging data. The difference between the two groups will be analyzed. To find the difference between the Type 1 and Type 2 narcolepsy by brain imaging characteristics. Use these data to find the special parameter by "machine learning" and build a predictive model; (2)To collect comprehensive narcolepsy and non-narcolepsy HLA typing data. Attempt to understand the HLA profile of narcoleptic patients and their parents in Taiwan. To analyze the difference between the two groups of Type 1 and Type 2 narcolepsy. Use these data of HLA typing characteristics to find the special parameter by "machine learning" and to establish a predictive model; and (3) categorize and group narcolepsy clinical data, sleep examination data, and the aforementioned data based on machine learning concept and build a predictive model as the basis for developing a fast and accurate" narcolepsy diagnostic tool or model" in the future. Research method: This is a case control study. There are 400 subjects (age 9 - 45) will be collected. These subjects will be divided into the three following groups: (1) experimental group (narcolepsy Type 1, 200 subjects); (2) experimental group (narcolepsy Type 2, 100 subjects); and (3) control group (age and gender matched non-narcolepsy subjects, 100). The investigators will collect all the clinical data for each subject, including clinical characteristics, sleep examination data, actigraphy, HLA typing, and brain imaging data. Data analysis method: the narcolepsy clinical data, sleep examination data, and the aforementioned data were categorized and grouped through data analysis based on computer machine learning, neural network, and predictive model effectiveness analysis concepts. Then the investigators will built a predictive model based on the results.
- Conditions
- Narcolepsy
- Being tested
- "MAGSTIM" reprtitive Transcranial Magnetic Stimulator (rTMS) System, sham control
- Keywords
- hypersomnia, narcolepsy, depression, transcranial magnetic stimulation, neurocognitive function, quality of life
- Medical subject headings
- Narcolepsy, Disorders of Excessive Somnolence, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"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.
sham controlDevice
sham control
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: "MAGSTIM" reprtitive Transcranial Magnetic Stimulator (rTMS) System |
| Narcolepsy with depression | Sham comparator | Sham-control Receives: Device: sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Screening and following up to six months.
Secondary outcomes (17)
Polysomnography -SE
Change in sleep efficiency (SE, %)based on PSG during the study.
Measured: Screening and following up to six months.
Polysomnography -TST
Change in total sleep time (TST, mins) based on PSG during the study.
Measured: Screening and following up to six months.
Polysomnography -WASO
Change in slow wave sleep (SWS, %) based on PSG during the study.
Measured: Screening and following up to six months.
Polysomnography -REM
Change in REM sleep (%) based on PSG during the study.
Measured: Screening and following up to six months.
Polysomnography -SL
Change in sleep latency (SL, mins) based on PSG during the study.
Measured: Screening and following up to six months.
Polysomnography -SWS
Change in slow wave sleep (SWS, %) based on PSG during the study.
Measured: Screening and following up to six months.
Multiple sleep latency test
Change in Change in sleep latency (SL, mins) based on MSLT during the study.
Measured: Screening and following up to six months.
Conners' Continuous Performance Test
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.
Measured: Screening and following up to six months.
Wisconsin Card Sorting Test
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.
Measured: Screening and following up to six months.
Epworth Sleepoiness Scale
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.
Measured: Screening and following up to six months.
Short Form-36
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.
Measured: Screening and following up to six months.
PET/MRI
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.
Measured: Screening and following up to six months.
Actigraphy-WASO
Wake after sleep onset (WASO) based on actigraphy during the study.
Measured: Screening and following up to six months.
Actigraphy-SE
Sleep efficiency (SE, %) based on actigraphy during the study.
Measured: Screening and following up to six months.
Actigraphy-TST
Total sleep time (TST, mins) based on actigraphy during the study.
Measured: Screening and following up to six months.
Pittsburgh Sleep Quality Index
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.
Measured: Screening and following up to six months.
Visual Analogue Scale
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)
Measured: Screening and following up to six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start22 Feb 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Shu Huang, PhD, Study director, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884112
- Sponsor's protocol ID
- 202102036A3
- Status last verified
- Apr 2023
- First submitted
- 9 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15700728Barbey 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.
PubMed 22789779Buskova 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.
PubMed 26707042Blouin 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.
PubMed 16135770Brooks S, Black J. Novel therapies for narcolepsy. Expert Opin Investig Drugs. 2002 Dec;11(12):1821-7. doi: 10.1517/13543784.11.12.1821.
PubMed 12457441Corbetta 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.
PubMed 11994752Dauvilliers Y, Arnulf I, Mignot E. Narcolepsy with cataplexy. Lancet. 2007 Feb 10;369(9560):499-511. doi: 10.1016/S0140-6736(07)60237-2.
PubMed 17292770Nardone 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.
PubMed 20810311Huang 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.
PubMed 27663355Huang 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.
PubMed 29602910Nishino 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.
PubMed 10615891Johns 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.
PubMed 1798888Kales 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.
PubMed 7065934Kedzior 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.
PubMed 26828370Lee 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.
PubMed 30513530
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Comorbid Depression of Patients With Narcolepsy by Intermittent Theta Burst Stimulation: A Preliminary Study
- ClinicalTrials.gov ID
- NCT05884112
- Acronym / sponsor ID
- 202102036A3
- Conditions
- Narcolepsy
- Keywords
- hypersomnia, narcolepsy, depression, transcranial magnetic stimulation, neurocognitive function, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purposes of this study are as follows: (1) To collect comprehensive narcolepsy and non-narcolepsy brain imaging data. The difference between the two groups will be analyzed. To find the difference between the Type 1 and Type 2 narcolepsy by brain imaging characteristics. Use these data to find the special parameter by "machine learning" and build a predictive model; (2)To collect comprehensive narcolepsy and non-narcolepsy HLA typing data. Attempt to understand the HLA profile of narcoleptic patients and their parents in Taiwan. To analyze the difference between the two groups of Type 1 and Type 2 narcolepsy. Use these data of HLA typing characteristics to find the special parameter by "machine learning" and to establish a predictive model; and (3) categorize and group narcolepsy clinical data, sleep examination data, and the aforementioned data based on machine learning concept and build a predictive model as the basis for developing a fast and accurate" narcolepsy diagnostic tool or model" in the future. Research method: This is a case control study. There are 400 subjects (age 9 - 45) will be collected. These subjects will be divided into the three following groups: (1) experimental group (narcolepsy Type 1, 200 subjects); (2) experimental group (narcolepsy Type 2, 100 subjects); and (3) control group (age and gender matched non-narcolepsy subjects, 100). The investigators will collect all the clinical data for each subject, including clinical characteristics, sleep examination data, actigraphy, HLA typing, and brain imaging data. Data analysis method: the narcolepsy clinical data, sleep examination data, and the aforementioned data were categorized and grouped through data analysis based on computer machine learning, neural network, and predictive model effectiveness analysis concepts. Then the investigators will built a predictive model based on the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narcolepsy (type1 +type 2) with depression | Experimental | Device: "MAGSTIM" reprtitive Transcranial Magnetic Stimulator (rTMS) SystemStimulate 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. |
| Narcolepsy with depression | Sham comparator | Device: sham controlSham-control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "MAGSTIM" reprtitive Transcranial Magnetic Stimulator (rTMS) SystemiTBS 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. | Device | Narcolepsy (type1 +type 2) with depression |
| sham controlsham control | Device | Narcolepsy with depression |
Primary outcome
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.
The Beck Anxiety Inventory
Time frame: Screening and following up to six months.
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.
17 secondary outcomes
Polysomnography -SE
Time frame: Screening and following up to six months.
Polysomnography -TST
Time frame: Screening and following up to six months.
Polysomnography -WASO
Time frame: Screening and following up to six months.
Polysomnography -REM
Time frame: Screening and following up to six months.
Polysomnography -SL
Time frame: Screening and following up to six months.
Polysomnography -SWS
Time frame: Screening and following up to six months.
Multiple sleep latency test
Time frame: Screening and following up to six months.
Conners' Continuous Performance Test
Time frame: Screening and following up to six months.
Wisconsin Card Sorting Test
Time frame: Screening and following up to six months.
Epworth Sleepoiness Scale
Time frame: Screening and following up to six months.
Short Form-36
Time frame: Screening and following up to six months.
PET/MRI
Time frame: Screening and following up to six months.
Actigraphy-WASO
Time frame: Screening and following up to six months.
Actigraphy-SE
Time frame: Screening and following up to six months.
Actigraphy-TST
Time frame: Screening and following up to six months.
Pittsburgh Sleep Quality Index
Time frame: Screening and following up to six months.
Visual Analogue Scale
Time frame: Screening and following up to six months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Background: PubMed 15700728Arand 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.
- Background: PubMed 22789779Barbey 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.
- Background: PubMed 26707042Buskova 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.
- Background: PubMed 16135770Blouin 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.
- Background: PubMed 12457441Brooks S, Black J. Novel therapies for narcolepsy. Expert Opin Investig Drugs. 2002 Dec;11(12):1821-7. doi: 10.1517/13543784.11.12.1821.
- Background: PubMed 11994752Corbetta 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.
- Background: PubMed 17292770Dauvilliers Y, Arnulf I, Mignot E. Narcolepsy with cataplexy. Lancet. 2007 Feb 10;369(9560):499-511. doi: 10.1016/S0140-6736(07)60237-2.
- Background: PubMed 20810311Nardone 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.
- Background: PubMed 27663355Huang 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.
- Background: PubMed 29602910Huang 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.
- Background: PubMed 10615891Nishino 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.
- Background: PubMed 1798888Johns 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Shu Huang, PhD study director
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "MAGSTIM" reprtitive Transcranial Magnetic Stimulator (rTMS) System in people with Narcolepsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-shu Huang (+886 3 3281200 ext. 8539, yushuhuang1212@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (time frame: Screening and following up to six months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05884112, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.