Study on the Mode and Mechanism of Ultra-low Frequency rTMS for Sleep Disorders in Patients With Parkinson's Disease
20. mars 2021 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
99
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Shandong
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Jinan, Shandong, Kina
- The First Affiliated Hospital of Shandong First Medical University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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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Aktiv komparator: 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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Sham-komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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change from length of sleep at one week
Tidsramme: one week
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Xiuhua Li, MD, Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. desember 2019
Primær fullføring (Forventet)
20. desember 2021
Studiet fullført (Forventet)
20. april 2022
Datoer for studieregistrering
Først innsendt
8. mars 2021
Først innsendt som oppfylte QC-kriteriene
15. mars 2021
Først lagt ut (Faktiske)
18. mars 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. mars 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. mars 2021
Sist bekreftet
1. mars 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske prosesser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Nevrologiske manifestasjoner
- Parkinsonlidelser
- Basal ganglia sykdommer
- Bevegelsesforstyrrelser
- Synukleinopatier
- Nevrodegenerative sykdommer
- Sykdom
- Parkinsons sykdom
- Søvnvåkenforstyrrelser
- Parasomnier
Andre studie-ID-numre
- ULFRTMS-S
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