Study on the Mode and Mechanism of Ultra-low Frequency rTMS for Sleep Disorders in Patients With Parkinson's Disease
20 mars 2021 uppdaterad 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.
Studieöversikt
Status
Okänd
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
99
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Shandong
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Jinan, Shandong, Kina
- The First Affiliated Hospital of Shandong First Medical University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
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.
|
Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
|
|
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
|
Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
|
|
Sham Comparator: the control group
The instrument is not working, only in exhaust mode.
|
Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
change from length of sleep at one week
Tidsram: one week
|
Sleep duration was monitored by polysomnography.It's measured in minutes.
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one week
|
|
change from ratio of stage 3 sleep in total sleep at one week
Tidsram: one week
|
The proportion of phase 3 sleep in total sleep was monitored by polysomnography.It's in percentages.
|
one week
|
|
change from limb movement of sleep at one week
Tidsram: one week
|
The number of body movements during sleep was recorded by polysomnography.It's in units of times per night.
|
one week
|
|
change from nocturnal arousal frequency at one week
Tidsram: one week
|
The number of nocturnal awakenings was recorded by polysomnography.It's in units of times per night.
|
one week
|
|
change from Pittsburgh sleep quality index scale at one week
Tidsram: 1 day before treatment、1 day after treatment、1 week after treatment、1 moth after treatment
|
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.
|
1 day before treatment、1 day after treatment、1 week after treatment、1 moth after treatment
|
|
Interleukin 6
Tidsram: 1 day before treatment and 1 day after treatment
|
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
Tidsram: one week
|
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.
|
one week
|
|
change from Parkinson's disease sleep scale at one week
Tidsram: 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 ranges from 0 to 150.
The higher the score, the better the sleep.
|
one week
|
|
change from movement disorders association - comprehensive rating scale of Parkinson's disease at one week
Tidsram: 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 260, and the higher the score, the more severe the symptoms were.
|
one week
|
|
change from Parkinson's disease quality of life scale one week
Tidsram: 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 ranges from 0 to 156, and the higher the score, the worse the quality of life.
|
one week
|
|
change from Hamilton depression scale at one week
Tidsram: 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.
|
one week
|
|
change from Hamilton anxiety scale at one week
Tidsram: 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 ranges from 0 to 56, and the higher the score, the more serious the anxiety.
|
one week
|
|
change from simple mental state scale at one week
Tidsram: 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 ranges from 0 to 30, and the lower the score, the more severe the cognitive impairment.
|
one week
|
|
change from Montreal cognitive assessment scale at one week
Tidsram: 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 ranges from 0 to 30, and the lower the score, the more severe the cognitive impairment.
|
one week
|
|
change from magnetic resonance imaging of the brain at one month
Tidsram: one month
|
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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Xiuhua Li, MD, Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 december 2019
Primärt slutförande (Förväntat)
20 december 2021
Avslutad studie (Förväntat)
20 april 2022
Studieregistreringsdatum
Först inskickad
8 mars 2021
Först inskickad som uppfyllde QC-kriterierna
15 mars 2021
Första postat (Faktisk)
18 mars 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 mars 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 mars 2021
Senast verifierad
1 mars 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Patologiska processer
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Neurologiska manifestationer
- Parkinsons sjukdom
- Basala ganglia sjukdomar
- Rörelsestörningar
- Synukleinopatier
- Neurodegenerativa sjukdomar
- Sjukdom
- Parkinsons sjukdom
- Vakna sömnstörningar
- Parasomnier
Andra studie-ID-nummer
- ULFRTMS-S
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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Nej
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