Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia
2018年3月14日 更新者：Mark Halko、Beth Israel Deaconess Medical Center
Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia
The aim of this study is to look at the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a therapeutic intervention for patients with schizophrenia.
The primary outcome is improvement in negative symptoms related to schizophrenia.
The investigators are focusing on negative symptoms given their greater resistance to pharmacological and other established therapies.
If the investigators trial were to show beneficial effects, its clinical significance would be great.
調査の概要
詳細な説明
This study builds on the results of a previous phase 1, single-site study in which we demonstrated the safety of image-guided theta burst stimulation (TBS) form of rTMS over the cerebellar vermis (Demirtas-Tatlidede et al., 2010) in eigh patients with schizophrenia.
The primary goal of the present study is to assess efficacy of iTBS to the cerebellar vermis on positive and negative symptoms of schizophrenia. A second, added goal is to investigate the mechanisms of the expected clinical improvement.
Schizophrenia is a leading cause of mental disability and current treatments still remain only partially successful for many patients. Our underlying hypothesis is that modulation of the cerebellar vermis may enhance activity of the neural systems that sub-serve cognition and emotion, reestablish the disturbed cerebellar regulation in schizophrenic patients, and produce clinical improvement.
研究の種類
介入
入学 (実際)
22
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
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Massachusetts
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Boston、Massachusetts、アメリカ、02134
- Beth Israel Deaconess Medical Center
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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～65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:
- Age between 18-65 years
- Diagnosis of schizophrenia according to DSM-IV criteria (Diagnostic and Statistical Manual) by a board-certified psychiatrist
Exclusion Criteria:
- Preexisting or progressive neurological disorders
- Prior neurological procedures
- Previous head injury
- Change in antipsychotic medication during the last 4 weeks
- Been an inpatient in a psychiatry clinic within the last month
- Any other axis 1 diagnosis
- Patients may not be actively enrolled in a separate intervention study
- Patients unable to undergo a brain MRI
- Any unstable medical condition
- History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform_ EEG, or family history of treatment resistant epilepsy
- Possible pregnancy. All female participants of child bearing age are required to have a pregnancy test.
- Any metal in the brain, skull, or elsewhere unless approved by the responsible MD
- Any medical devices (ie. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
- Substance abuse (alcohol, amphetamines, cocaine, MDMA [methylenedioxymethamphetamine], ecstasy, PCP [phencyclidine], Angle dust) or dependence within the past six months
- No medication is an absolute exclusion from TMS. Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following: the patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other CNS (central nervous system) active drugs (the published TMS guidelines review of medications to be considered with TMS)
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：トリプル
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：Active rTMS
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
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intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session. Sham participants will undergo the same procedures as those in the active rTMS group.
他の名前：
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偽コンパレータ：Sham rTMS
Sham rTMS to the vermis (lobule VII) of the cerebellum.
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intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session. Sham participants will undergo the same procedures as those in the active rTMS group.
他の名前：
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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 Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subscale
時間枠：Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
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Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia.
The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity.
Change from baseline on the PANSS Positive Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity.
Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
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Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
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Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale
時間枠：Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
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Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia.
The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity.
Change from baseline on the PANSS Negative Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity.
Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
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Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
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Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subscale
時間枠：Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
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Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia.
The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity.
Change from baseline on the PANSS General Subscale can range from -96 to +96; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity.
Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
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Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
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Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness
時間枠：Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
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Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score.
The CGI Severity of Illness is a 7-point subscale in which a clinician rates the severity of the patient's illness at the time of assessment.
Ratings range from 1 to 7 and higher values represent more severe psychopathology: 1 indicates a normal and not at all ill patient and 7 indicates among the most extremely ill patients.
Change from baseline on the CGI Severity of Illness subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology.
Severity of Illness was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
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Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
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Clinical Global Impression (CGI) Global Improvement
時間枠：Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
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Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score.
The CGI Global Improvement is a 7-point subscale in which a clinician assesses how much a patient's illness has changed compared to baseline.
Ratings range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse.
Change from baseline on the CGI Global Improvement subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology.
Global Improvement was assessed after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
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Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline on the Calgary Depression Scale for Schizophrenia
時間枠：Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
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The Calgary Depression Scale for Schizophrenia is a 9-item scale that assesses depressive symptoms in patients with schizophrenia.
Each item is rated separately and ratings range from 0 to 3. Higher values represent more severe depressive symptoms: 0 indicates an absent symptom and 3 indicates a severe symptom.
The overall Calgary Depression Scale score is computed by summing each item.
The total Calgary Depression Scale score ranges from 0 to 27, with higher values representing more severe depression in patients with schizophrenia.
Change from baseline on the Calgary Depression Scale can range from -27 to +27, with negative values representing an improvement in depressive symptoms and positive values representing worsening depressive symptom severity.
Depression was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
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Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
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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。
捜査官
- 主任研究者：Mark Halko, Ph.D.、Beth Israel Deaconess Medical Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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便利なリンク
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
2012年2月1日
一次修了 (実際)
2015年11月1日
研究の完了 (実際)
2015年11月1日
試験登録日
最初に提出
2012年3月1日
QC基準を満たした最初の提出物
2012年3月9日
最初の投稿 (見積もり)
2012年3月13日
学習記録の更新
投稿された最後の更新 (実際)
2018年4月12日
QC基準を満たした最後の更新が送信されました
2018年3月14日
最終確認日
2018年3月1日
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