An interventional study of "MAGSTIM" reprtitive Transcranial Magnetic Stimulator (rTMS) System and sham control in Narcolepsy, sponsored by Chang Gung Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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.
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.
157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.
This study's planned enrollment of 105 is above the median of 78 across 114 interventional studies indexed under Narcolepsy.
Browse Narcolepsy studies →Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
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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
Sham-control
Device: sham control
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 control
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.
Time frame: 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.
Time frame: Screening and following up to six months.
Polysomnography -SE
Change in sleep efficiency (SE, %)based on PSG during the study.
Time frame: Screening and following up to six months.
Polysomnography -TST
Change in total sleep time (TST, mins) based on PSG during the study.
Time frame: Screening and following up to six months.
Polysomnography -WASO
Change in slow wave sleep (SWS, %) based on PSG during the study.
Time frame: Screening and following up to six months.
Polysomnography -REM
Change in REM sleep (%) based on PSG during the study.
Time frame: Screening and following up to six months.
Polysomnography -SL
Change in sleep latency (SL, mins) based on PSG during the study.
Time frame: Screening and following up to six months.
Polysomnography -SWS
Change in slow wave sleep (SWS, %) based on PSG during the study.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Screening and following up to six months.
Actigraphy-WASO
Wake after sleep onset (WASO) based on actigraphy during the study.
Time frame: Screening and following up to six months.
Actigraphy-SE
Sleep efficiency (SE, %) based on actigraphy during the study.
Time frame: Screening and following up to six months.
Actigraphy-TST
Total sleep time (TST, mins) based on actigraphy during the study.
Time frame: 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.
Time frame: 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)
Time frame: Screening and following up to six months.
Plan to share: No
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