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The Effect of Repetitive Transcranial Magnetic Stimulation in Schizophrenia

2021年9月21日 更新者:Shanghai Mental Health Center

The Effect of Repetitive Transcranial Magnetic Stimulation in Schizophrenia--A Randomized , Double-blind fMRI Study

Repetitive Transcranial Magnetic Stimulation (rTMS) can modulate neuronal activity and has been shown to improve symptoms in patients with schizophrenia, but the underlying neural mechanism is unknown.This study hypothesized that repetitive transcranial magnetic stimulation of the cerebellar vermis can alter the ciliary-related functional connections in schizophrenia, thereby improving negative symptoms, cognitive function, and emotional symptoms. Therefore, this study will firstly explore the difference in cerebellar functional connectivity between patients and healthy controls, and on this basis, patients undergo a resting state functional magnetic resonance scan before and after rTMS intervention in the cerebellar vermis, and observe the cerebellar function connection in the treatment. Before and after changes, analyze the relationship between these changes and clinical efficacy to explore the neural mechanisms of efficacy.

調査の概要

詳細な説明

Repetitive Transcranial Magnetic Stimulation (rTMS) can modulate neuronal activity and has been shown to improve symptoms in patients with schizophrenia, but the underlying neural mechanism is unknown.This study hypothesized that repetitive transcranial magnetic stimulation of the cerebellar vermis can alter the ciliary-related functional connections in schizophrenia, thereby improving negative symptoms, cognitive function, and emotional symptoms. Therefore, this study will firstly explore the difference in cerebellar functional connectivity between patients and healthy controls, and on this basis, patients undergo a resting state functional magnetic resonance scan before and after rTMS intervention in the cerebellar vermis, and observe the cerebellar function connection in the treatment. Before and after changes, analyze the relationship between these changes and clinical efficacy to explore the neural mechanisms of efficacy.

  1. Aim of the study 1.1 Using resting state functional magnetic resonance imaging to observe the differences in cerebellar functional connections between schizophrenia patients and healthy controls, and to further understand the role of cerebellar abnormalities in the clinical symptoms of schizophrenia; 1.2 Provide evidence-based evidence and imaging evidence for the clinical efficacy of rTMS intervention in cerebellar palsy for patients with schizophrenia, and further understand the neural mechanism of efficacy.
  2. Content of the study 2.1 Based on previous studies, this study will use resting-state functional magnetic resonance imaging to observe abnormalities in behavioral and cerebellar neural networks in patients with schizophrenia compared with healthy controls, and to explore these abnormalities and schizophrenia. The relationship between clinical symptoms. 2.2 According to the research hypothesis, this study will perform a resting-state functional magnetic resonance scan of the patient before and after rTMS intervention in the cerebellar vermis. The functional connection analysis method is used to observe the changes of the cerebellar nerve network before and after treatment, and the imaging data and clinical evaluation. The data of the scale is combined to explore the neural mechanisms of treatment.
  3. Study design This study used resting-state functional magnetic resonance imaging to investigate the differences in cerebrospinal function connections between schizophrenia and healthy controls. Based on this, a randomized double-blind control design was used to study the repetitive transcranial magnetic stimulation of the cerebellar vermis for patients with schizophrenia. The clinical efficacy of the treatment and the neural mechanisms of the therapeutic effect. Inpatients with schizophrenia were admitted to the Shanghai Mental Health Center, and patients who met the criteria and successfully enrolled were randomly grouped (by random number table method), corresponding to the rTMS true stimulation group or the rTMS pseudo-stimulation group. Except for the rTMS operator, neither the patient nor the evaluator of the scale knew the patient's grouping.

研究の種類

介入

段階

  • 適用できない

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~55年 (大人)

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:

  • The patient met the diagnostic criteria for schizophrenia in DSM-IV;
  • 18-55 years old;
  • Right handed;
  • On stable doses of psychotropic medications.

Exclusion Criteria:

  • DSM-IV diagnosis of other Axis I disorders;
  • Contraindications to TMS or MRI;
  • Patients receiving ECT (electro-convulsive therapy) in last 6months;
  • Left-handedness。

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:ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:active rTMS
The Active rTMS: The magnetic head uses the Magro X100's "8"-shaped coil, and the intervention site is the cerebellar vermis (1 cm below the occipital carina). The stimulation intensity is gradually increased by the 80%-100% exercise threshold according to the patient's tolerance. The total number of stimulation pulses per day is 600, the basic frequency is 5 Hz, and one short burst stimulus is given every 200 milliseconds. In each short array, three single pulses with a frequency of 50 Hz are buried, and every 10 short bursts are stimulated for 8 s. A total of 200 short bursts of stimulation. Intervention once a day, 5 times a week, intervention for 2 weeks, a total of 10 times.
Repetitive Transcranial Magnetic Stimulation (rTMS) is a widely used non-invasive neuromodulation technique that induces excitatory changes in the cerebral cortex stimulated by repeated pulsed magnetic fields on the scalp.
偽コンパレータ:sham rTMS
The sham rTMS: The sham stimulation method was to invert the "8" shaped coil, which was 180° to the scalp, and other intervention parameters were consistent with the study group.
Repetitive Transcranial Magnetic Stimulation (rTMS) is a widely used non-invasive neuromodulation technique that induces excitatory changes in the cerebral cortex stimulated by repeated pulsed magnetic fields on the scalp.

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
FCS
時間枠:4 weeks
FCS (functional connectivity strength) value. The Pearson's correlation analysis was used to analyze the time series signals of the brain voxels, and the functional connection matrix model of each subject was established. The gray matter template is used to calculate the mean value of the functional connection between each brain voxel and other voxels, which is the FCS value of the voxel.
4 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
PANSS
時間枠:4 weeks
The clinical efficacy was determined according to the PANSS reduction rate. The PANSS reduction rate was calculated as the difference between the PANSS total score before and after treatment divided by the pre-treatment PANSS total score. The PANSS reduction rate was judged to be significant progress, progress, and ineffective by 50% to 100%, 20% to 49%, and 0 to 19%, respectively.
4 weeks

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。

捜査官

  • スタディディレクター:Jun Cai、Shanghai Mental Health Center

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 (予想される)

2019年12月1日

一次修了 (予想される)

2020年12月1日

研究の完了 (予想される)

2021年6月1日

試験登録日

最初に提出

2018年11月6日

QC基準を満たした最初の提出物

2018年11月7日

最初の投稿 (実際)

2018年11月9日

学習記録の更新

投稿された最後の更新 (実際)

2021年9月27日

QC基準を満たした最後の更新が送信されました

2021年9月21日

最終確認日

2021年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • JunCai

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

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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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Repetitive transcranial magnetic stimulationの臨床試験

  • Johns Hopkins University
    University of Texas at Austin; Baszucki Brain Research Fund; Magnus Medical
    完了
    双極性うつ病 | 双極Ⅰ型障害
    アメリカ
3
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