- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04804176
Study on the Mode and Mechanism of Ultra-low Frequency rTMS for Sleep Disorders in Patients With Parkinson's Disease
20. března 2021 aktualizováno: Lili Cao, Qianfoshan Hospital
Study on the Mode and Mechanism of Ultra-low Frequency Repetitive Transcranial Magnetic Stimulation for Sleep Disorders in Patients With Parkinson's Disease
The study by giving a sleep disorder Parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder Parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.
Přehled studie
Postavení
Neznámý
Intervence / Léčba
Detailní popis
Parkinson's disease is the second most common chronic neurodegenerative disease.At present, researchers focus not only on the motor symptoms of Parkinson's disease, but also on the non-motor symptoms of Parkinson's disease (including mood disorders, sleep disorders, cognitive decline, and autonomic nervous kinetic disorder, etc.).The principle of transcranial magnetic stimulation is based on the electromagnetic principle proposed by Faraday.
When an electrifying coil is suspended over the scalp at a certain distance, the magnetic field generated by the coil current and the electric field generated by the magnetic field can reach the skull and directly or indirectly affect the synapses and neurons in the brain.The study by giving a sleep disorder Parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder Parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.
Typ studie
Intervenční
Zápis (Očekávaný)
99
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Shandong
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Jinan, Shandong, Čína
- The First Affiliated Hospital Of Shandong First Medical University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 70 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- in line with international Movement disorders association (the Movement Disorder Society, MDS) in 2015 the diagnosis of Parkinson's disease diagnosis standard and China standard (2016)
- can cooperate to complete rating scale, the sleep monitoring, imaging and blood test
- have a sleep disorder
- aged 18 to 70 years old
- agree to participate in this experiment, and have signed the informed consent
Exclusion Criteria:
- superposition of diagnosed with Parkinson's syndrome
- secondary diagnosed Parkinson's syndrome
- is equipped with heart pacemakers and other metal implants
- cannot achieve scale assessment
- has significant malignant diseases
- has a history of seizures
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation
The study used 5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation for 35 minutes once a day.Every 7 days is a cycle.The stimulus intensity was 400GS.
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Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
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Aktivní komparátor: GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation
The study used GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation for 35 minutes once a day.Every 7 days is a cycle.The stimulus intensity was 400GS
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Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
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Falešný srovnávač: the control group
The instrument is not working, only in exhaust mode.
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Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
change from length of sleep at one week
Časové okno: one week
|
Sleep duration was monitored by polysomnography.It's measured in minutes.
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one week
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change from ratio of stage 3 sleep in total sleep at one week
Časové okno: one week
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The proportion of phase 3 sleep in total sleep was monitored by polysomnography.It's in percentages.
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one week
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change from limb movement of sleep at one week
Časové okno: one week
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The number of body movements during sleep was recorded by polysomnography.It's in units of times per night.
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one week
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change from nocturnal arousal frequency at one week
Časové okno: one week
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The number of nocturnal awakenings was recorded by polysomnography.It's in units of times per night.
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one week
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change from Pittsburgh sleep quality index scale at one week
Časové okno: 1 day before treatment、1 day after treatment、1 week after treatment、1 moth after treatment
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 2L, and the higher the score, the worse the sleep quality.
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1 day before treatment、1 day after treatment、1 week after treatment、1 moth after treatment
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Interleukin 6
Časové okno: 1 day before treatment and 1 day after treatment
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It plays an important role in central nervous system diseases.
In PD, the increase of IL-6 is the body's self-defense mechanism to protect neurons, and the change of IL-6 in peripheral blood can reflect the change of injury aggravation and recovery.It is also associated with psychiatric symptoms, and IL-6 is elevated in major depression.
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1 day before treatment and 1 day after treatment
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change from the Epworth sleepiness scale at one week
Časové okno: one week
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The scale has an overall score range of 0 to 24, with higher scores indicating more severe sleepiness.
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one week
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change from Parkinson's disease sleep scale at one week
Časové okno: one week
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 150.
The higher the score, the better the sleep.
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one week
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change from movement disorders association - comprehensive rating scale of Parkinson's disease at one week
Časové okno: one week
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranged from 0 to 260, and the higher the score, the more severe the symptoms were.
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one week
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change from Parkinson's disease quality of life scale one week
Časové okno: one week
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 156, and the higher the score, the worse the quality of life.
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one week
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change from Hamilton depression scale at one week
Časové okno: one week
|
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranged from 0 to 96, and the higher the score, the more severe the depression was.
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one week
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change from Hamilton anxiety scale at one week
Časové okno: one week
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 56, and the higher the score, the more serious the anxiety.
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one week
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change from simple mental state scale at one week
Časové okno: one week
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 30, and the lower the score, the more severe the cognitive impairment.
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one week
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change from Montreal cognitive assessment scale at one week
Časové okno: one week
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 30, and the lower the score, the more severe the cognitive impairment.
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one week
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change from magnetic resonance imaging of the brain at one month
Časové okno: one month
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The ADC values of sleep-related brain tissues were measured by diffusion weighted magnetic resonance imaging of the brain.Compare the difference between the measured results on both sides of the same site and record the difference.
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one month
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Xiuhua Li, MD, Qianfoshan Hospital,The First Affiliated Hospital of Shandong First Medical University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
20. prosince 2019
Primární dokončení (Očekávaný)
20. prosince 2021
Dokončení studie (Očekávaný)
20. dubna 2022
Termíny zápisu do studia
První předloženo
8. března 2021
První předloženo, které splnilo kritéria kontroly kvality
15. března 2021
První zveřejněno (Aktuální)
18. března 2021
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
24. března 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. března 2021
Naposledy ověřeno
1. března 2021
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Duševní poruchy
- Patologické procesy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Neurologické projevy
- Parkinsonské poruchy
- Bazální gangliové choroby
- Poruchy pohybu
- Synukleinopatie
- Neurodegenerativní onemocnění
- Choroba
- Parkinsonova choroba
- Poruchy spánku a bdění
- Parasomnie
Další identifikační čísla studie
- ULFRTMS-S
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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