rTMS for Working Memory Deficits in Schizophrenia
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Working Memory Deficits in Schizophrenia and Effects on Brain Structure
調査の概要
詳細な説明
This study is a randomized, double blind, sham controlled study to evaluate the efficacy of repetitive transcranial magnetic stimulation as a treatment for working memory deficits in individuals with schizophrenia or schizoaffective disorder between 18 and 59 years of age. The study duration is approximately 3 months, with the rTMS sessions lasting for 4 weeks, 5 times a week, for about 1 hour each. Several scales will be used to assess symptom severity as part of the clinical assessment. Cognition will be assessed using a validated battery and the N-back task.
This study also involves a type of brain imaging known as magnetic resonance imaging (MRI) at the beginning and at the end of the 4 weeks of daily rTMS to better understand the effects of rTMS on brain structure and function. Investigators will measure the size and connections of different parts of the brain to assess brain structure and blood flow while you are completing some basic tasks to assess brain function. We will also collect two blood samples (before and after rTMS treatment) to see if certain proteins change in response to treatment. Finally, an analysis of genetic material will be conducted to see if genes play a role in differences in how people respond to treatment.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ
- Centre for Addiction and Mental Health
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Between 18 and 59 years of age
- Current diagnosis of Schizophrenia or Schizoaffective Disorder
- Able to provide written informed consent
- Fluency in the English Language
Exclusion Criteria:
- Have a history of substance abuse or dependence in the last 6 months
- Have a concomitant major and unstable medical or neurologic illness
- Have a history of seizures or have a first degree relative with a history of a seizure disorder
- Current pregnancy or a plan to become pregnant during the duration of the study
- Clinical instability: determined by treating physician
- Have received electroconvulsive therapy (ECT) within the last year
- Have a history of repetitive transcranial magnetic stimulation (rTMS)
- Are taking a benzodiazepine at a dose greater than Lorazepam 2mg or equivalent
- Are taking any non-benzodiazepine anticonvulsant
- Have a cardiac pacemaker, cochlear implant, implanted electronic device or non-electric metallic implant
研究計画
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 |
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アクティブコンパレータ：Active rTMS
Active treatment will be delivered at an intensity that is 90% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 25 stimulation trains of 30 stimuli each (i.e., 750 stimuli) and an intertrain interval of 30 sec. Treatment will be applied in sequential order bilaterally to the left and right dorsolateral prefrontal cortex (DLPFC). The order of bilateral stimulation (i.e. right then left or left then right) will be held constant for all 20 treatments. Intervention: Device: Repetitive Transcranial Magnetic Stimulation |
rTMS は、磁場を使用して神経細胞を刺激する非侵襲的な手順です。
他の名前：
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偽コンパレータ：Sham rTMS
Sham stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but with only the side-edge resting on the scalp. The coil will be angled 45 degrees away from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects. Intervention: Device: Repetitive Transcranial Magnetic Stimulation |
rTMS は、磁場を使用して神経細胞を刺激する非侵襲的な手順です。
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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Performance on the N-back working memory task
時間枠：4 weeks
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The primary outcome measure will be the performance on the N-back working memory task. Specifically, we will evaluate if rTMS results in a change in percent of correct responses in the N-back task. Note: the N-back is a continuous performance task that is commonly used to measure attention and working memory. |
4 weeks
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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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Brain Imaging Changes
時間枠：4 weeks
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For brain imaging we will test for group differences using: (1) cortical thickness (2) volumetric measures, (3) diffusion based measures.
Statistical tests measuring these differences will be conducted at baseline and following the final rTMS treatment session.
We will control for possible effects of neuroleptic medication on MRI measures by regressing mean dosage levels multiplied by number of years on medication, for each of five classes of medication (typical neuroleptics, atypical neuroleptics, antiparkinsonian anticholinergics, lithium, benzodiazepines)
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4 weeks
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協力者と研究者
捜査官
- 主任研究者：Aristotle Voineskos, MD, PHD、Centre for Addiction and Mental Health
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。
反復経頭蓋磁気刺激の臨床試験
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Johns Hopkins UniversityUniversity of Texas at Austin; Baszucki Brain Research Fund; Magnus Medical完了