Neuromodulation of Executive Control for Substance Use Disorders
TACS fMRI (NEC-TACS)
The purpose of this research study is to determine the effectiveness of a procedure called transcranial alternating current stimulation (tACS) using a device called StarStim cap and its effects on drug cravings.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Participants will undergo a 1-2-day screening that includes a urine drug screen, clinical interview, and self-reporting assessments, once screening is complete, participants will complete a (EEG) recording of your brainwaves. The EEG recording and electrode placement will take about 2 hours. The next portion of the study will involve the use of the StarStim device and an MRI, and you will be asked a series of questions while wearing the device. The day after the MRI scan you will receive a short phone call from study staff. You will be asked to participate in study visits for 2 or 3 days and have 1 follow-up visit. Total study duration for this research study is up to 2 weeks.
The electrical stimulation that the StarStim device uses is considered to be safe, and we are not anticipating any serious side effects. However, mild side effects could include headache, itching and tingling. There are additional risks involved with MRI scans.
You may not receive any personal benefits from being in this study. We hope the information learned from this study will benefit other people with similar conditions in the future.
If you are interested in learning more about this study, please continue to read below. Participating in this research study is voluntary; it is your choice.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Aref Pariz, PhD
- 電話番号：612-624-0134
- メール：Aref.Pariz@UTSouthwestern.edu
研究連絡先のバックアップ
- 名前：Stephanie Neaves, MRC
- 電話番号：214-648-86044
研究場所
-
-
Texas
-
Dallas、Texas、アメリカ、75235
- UT Southwestern Medical Center
-
-
参加基準
適格基準
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:
- Able to provide written consent and comply with study procedures.
- Adults aged 18 to 65 years at the time of consent.
- Meets the MINI diagnostic criteria for either methamphetamine use disorder (MUD).
Exclusion Criteria:
- Any contraindications for tACS or MRI scanning (tACS contraindication: history of seizures; potential MRI contraindications, up to the discretion of AIRC and CBH staff: metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder).
- Any medical condition or treatment with neurological sequelae (i.e., stroke, tumor).
- Over 9 months of abstinence from substance use.
- A head injury resulting in a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI).
- Presence of a condition that would render study measures difficult or impossible to administer or interpret.
- Entrance to the treatment program under a court mandate. (i.e. legally incarcerated).
- History of ECT or cortical energy exposure within the past 6 months, including participation in any other neuromodulation studies.
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：防止
- 割り当て：非ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Arm 1: Active intervention- tES (transcranial electrical stimulation), then Sham Intervention
tES is considered to be a safe brain stimulation technique that rarely results in adverse events. There is currently no evidence of serious side-effects. Mild side-effects that typically resolve upon discontinuing tACS. The subject may choose to discontinue stimulation at any time during the session if experiencing excessive discomfort or side effects. |
This study involves the use of an investigational device called StarStim. "Investigational" means that the device has not yet been approved by the U.S. Food & Drug Administration (FDA) for helping people recover from drug addiction. This study will help find out what effects, good and/or bad, this device has. The safety of this device in humans has been tested in prior research studies; however, some side effects may not yet be known comparator arm |
|
実験的：Arm 2: Sham intervention, then Active comparator intervention
|
This study involves the use of an investigational device called StarStim. "Investigational" means that the device has not yet been approved by the U.S. Food & Drug Administration (FDA) for helping people recover from drug addiction. This study will help find out what effects, good and/or bad, this device has. The safety of this device in humans has been tested in prior research studies; however, some side effects may not yet be known comparator arm |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Brain stimulation and MRI
時間枠：Individual participant data will be analyzed after completion of that participant's study procedures. The final study-level outcome analysis and reporting are planned by study completion, anticipated within one year. This analysis and reporting schedule
|
Task-dependent functional connectivity measured using psychophysiological interaction (PPI) analysis of blood oxygen level-dependent (BOLD) functional MRI data. PPI regression coefficients quantify differences in connectivity during drug-related versus neutral cues within the executive control network, including the dorsolateral prefrontal cortex and inferior parietal cortex, and between executive control regions and limbic regions, including the ventral striatum and amygdala. Connection-specific PPI coefficients will be reported separately, with within-participant comparisons between active in-phase, active anti-phase, and sham tACS conditions. |
Individual participant data will be analyzed after completion of that participant's study procedures. The final study-level outcome analysis and reporting are planned by study completion, anticipated within one year. This analysis and reporting schedule
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- STU20252588
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。