Study on the Mode and Mechanism of Ultra-low Frequency rTMS for Sleep Disorders in Patients With Parkinson's Disease
2021年3月20日 更新者：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.
調査の概要
状態
わからない
詳細な説明
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.
研究の種類
介入
入学 (予想される)
99
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Shandong
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Jinan、Shandong、中国
- The First Affiliated Hospital of Shandong First Medical University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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アクティブコンパレータ：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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偽コンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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change from length of sleep at one week
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
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one week
|
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change from Montreal cognitive assessment scale at one week
時間枠：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.
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one week
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change from magnetic resonance imaging of the brain at one month
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Xiuhua Li, MD、Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年12月20日
一次修了 (予想される)
2021年12月20日
研究の完了 (予想される)
2022年4月20日
試験登録日
最初に提出
2021年3月8日
QC基準を満たした最初の提出物
2021年3月15日
最初の投稿 (実際)
2021年3月18日
学習記録の更新
投稿された最後の更新 (実際)
2021年3月24日
QC基準を満たした最後の更新が送信されました
2021年3月20日
最終確認日
2021年3月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ULFRTMS-S
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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