Modulating Default Mode Network Function: A Transcranial Direct Current Stimulation (TDCS) Pilot Study (MDMN)
2021年12月5日 更新者：Jay Fournier
The primary purpose of this research is to gather scientific information about how different people's brains work when they look at different types of pictures.
This will help to improve the investigators' understanding of the way the brain works for people who are depressed or anxious, and this knowledge could help lead to better diagnosis and treatment.
調査の概要
詳細な説明
In this study the investigators are examining the effects of weak electrical stimulation on brain activity as measured by functional magnetic resonance imaging (fMRI).
MRI is a widely used method to obtain high resolution brain pictures that are routinely used for diagnostic and clinical purposes.
The electrical stimulation is applied on the scalp with a non-FDA approved method called tDCS (transcranial Direct Current Stimulation), typically equivalent to what a 6V battery would produce (and up to no more than 15V).
To compare, an AA battery delivers current at 1.5 volt.
While almost unnoticeable to the participants, these currents can still temporarily affect brain activity without causing adverse effects.
This stimulation would be applied while the participants are in the MRI scanner so that the brain activity can be measured.
The participants will have the opportunity to have a test session with the stimulation outside the scanner to get familiar with it.
研究の種類
介入
入学 (実際)
4
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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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh
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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～30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:
- Between 18-30years old
- Score > 10 on the QIDS or > 60 on the PROMIS-A
- We will use a flexible extreme groups recruitment strategy to ensure an adequate distribution of ESC scores. We will ensure that at least 62% of the sample will be composed of those scoring .5 SD above or below the mean, as measured by the NEO-PI-R. This value corresponds to the expected values assuming a normal distribution of the trait.
- Normal or corrected to normal vision with contact lenses
- Able to provide informed consent in English
- Right-handed (Annett criteria)
Exclusion Criteria:
- Have a history of head trauma with loss of consciousness.
- Have a systemic medical illness that may impact fMRI measures of cerebral blood flow.
- Meet standard exclusion criteria for fMRI scanning (e.g. claustrophobia, cardiac pacemakers, neural pacemakers, surgically implanted metal devices, cochlear implants, metal braces, or other MRI non-safe metal objects in the body).
- Are pregnant (self report and tested for as part of any scan by the scanning center and not this protocol)
- Not native English speaking or not fluent
- Premorbid NAART IQ estimate<85;
- Visual disturbance (worse than 20/40 Snellen visual acuity) that is not corrected
- If have visual disturbance, only access to correction with glasses (i.e., no access to contact lenses).
- Left/mixed handedness (Annett criteria), to ensure a uniform hemispheric dominance for interpretation of neuroimaging data
- Active suicidal ideation in need of immediate treatment
- Scoring below the cutoffs on both the QIDS and the PROMIS-A
- History of alcohol/substance use disorder (including nicotine) and/or illicit substance use (except cannabis) over the last 3 months, determined by the MINI. Lifetime/present cannabis use (non-disordered levels) will be allowed, given its common usage in individuals in this age range.
- Current or past psychotic-spectrum disorder
- 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：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Transcranial Direct Current Stimulation during fMRI
Each subject will undergo transcranial direct current stimulation twice while completing a task in the functional magnetic resonance imaging scanner.
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TDCS involves passing a weak current through the brain.
One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections.
TDCS has been explored as a possible treatment for depression, but results to date are mixed.
No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously.
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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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Blood Oxygen Level Dependent (BOLD) Response in the Precuneus During an Emotion Regulation Task Completed During fMRI Scanning.
時間枠：1 week (between baseline and repeat scanning)
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The investigators will determine the effects of TDCS on BOLD response in the precuneus/posterior cingulate gyrus. The BOLD signal is a measure of regional blood flow in the brain and is used as a proxy for neural activity in specific brain regions. Values below represent pre-post change in BOLD response to the emotion regulation task that participants complete during fMRI scanning. We hypothesize that tDCS applied to the target used in this study will decrease BOLD signal (lower values) during critical components of this task, normalizing function in this region. |
1 week (between baseline and repeat scanning)
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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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The Percentage of Patients Who Reported a Side Effect in the Active tDCS Condition But Not the Sham tDCS Condition
時間枠：30 minutes to 1 hour (the period during which the tDCS device was worn) on each of two scan days
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Potential side effects (e.g., headaches, dizziness, uncomfortable sensations, etc...) will be assessed after each tDCS and sham-tDCS administration. Side effects were assessed using a standardized form. Count below represents the number of participants who reported a mild or moderate side effect during active tDCS but not sham tDCS. |
30 minutes to 1 hour (the period during which the tDCS device was worn) on each of two scan days
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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：Jay C Fournier, Ph. D.、University of Pittsburgh
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)
2018年10月1日
一次修了 (実際)
2020年3月9日
研究の完了 (実際)
2020年3月9日
試験登録日
最初に提出
2020年10月10日
QC基準を満たした最初の提出物
2020年10月15日
最初の投稿 (実際)
2020年10月22日
学習記録の更新
投稿された最後の更新 (実際)
2022年1月4日
QC基準を満たした最後の更新が送信されました
2021年12月5日
最終確認日
2021年12月1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。
TDCS - transcranial direct current stimulationの臨床試験
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)完了