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Study on the Mode and Mechanism of Ultra-low Frequency rTMS for Sleep Disorders in Patients With Parkinson's Disease

20 de março de 2021 atualizado por: 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.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

99

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • China
    • Shandong
      • Jinan, Shandong, China
        • The First Affiliated Hospital Of Shandong First Medical University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Dispositivo: Ultra-low frequency repetitive transcranial magnetic stimulation
Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
Comparador Ativo: 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
Dispositivo: Ultra-low frequency repetitive transcranial magnetic stimulation
Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
Comparador Falso: the control group
The instrument is not working, only in exhaust mode.
Dispositivo: Ultra-low frequency repetitive transcranial magnetic stimulation
Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
change from length of sleep at one week
Prazo: one week
Sleep duration was monitored by polysomnography.It's measured in minutes.
one week
change from ratio of stage 3 sleep in total sleep at one week
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
1 day before treatment and 1 day after treatment
change from the Epworth sleepiness scale at one week
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
one month

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Qianfoshan Hospital

Investigadores

  • Investigador principal: Xiuhua Li, MD, Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de dezembro de 2019

Conclusão Primária (Antecipado)

20 de dezembro de 2021

Conclusão do estudo (Antecipado)

20 de abril de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

8 de março de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de março de 2021

Primeira postagem (Real)

18 de março de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de março de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de março de 2021

Última verificação

1 de março de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ULFRTMS-S

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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