治療抵抗性うつ病 (TRD) の補助治療としての経頭蓋直流刺激 (tDCS)
入院患者における治療抵抗性うつ病（TRD）の補助治療としての経頭蓋直流刺激（tDCS）の実現可能性研究
The researchers are trying to test the feasibility and acceptability of using transcranial Direct Current Stimulation (tDCS) in hospitalized adult patients with Treatment Resistant Depression (TRD), assess for any preliminary effect on depressive and cognitive symptoms, and explore the utility of biomarkers to assess response to tDCS.
調査の概要
詳細な説明
In this feasibility study the researchers propose to conduct a 5-day tDCS treatment protocol in hospitalized adult patients with TRD, with each treatment session lasting for 30 minutes, delivered twice daily, for a total of 10 stimulations over 5 days. Before and after the 5-day tDCS treatment protocol, assessments will include Montgomery-Asberg Depression Rating Scale (MADRS) to measure depressive symptoms, Snaith-Hamilton Pleasure Scale (SHAPS) to measure anhedonia, Stroop Test to measure memory and executive function, Revised Hopkins Verbal Learning Test (HVLT-R) to test verbal learning and memory, and Digital Symbol Coding Test (DSCT) to measure working memory. Electroencephalography (EEG) for objective electrophysiologic data will also be collected before and after tDCS. A wireless EEG unit (CGX, Cognionic, Inc.) will be used to collect EEG and peak alpha frequency (PAF) as potential target engagement marker for tDCS. The PAF measures the highest magnitude within the alpha range of brain oscillations, thought to reflect cognitive performance. Other potential predictors of treatment response measures collected at baseline include Adverse Childhood Experiences (ACE), premorbid intelligence quotient (pIQ), Wide Range Achievement Reading Test (WRART), and Socioeconomic Status (SES).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic in Rochester
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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
- 18 years and older
- Clinical diagnosis of treatment-resistant depression (defined as depression that does not remit following two or more treatment attempts of an adequate dose and duration of a minimum duration of 4 weeks)
- Hospitalized in psychiatric units
- Voluntary admission status
- Moderate or severe depression, defined by PHQ-9 ≥ 15
- Ability to provide informed consent
- Ability to adhere to protocol
Exclusion Criteria
- Bipolar disorder
- Active primary psychotic or substance use disorders (except nicotine dependence) within the past year
- Any active neurological condition (including seizure disorder, traumatic brain injury, stroke)
- Contraindications to tDCS (including pacemaker, metallic implants in the head or neck [except orthodontic hardware], skin disease causing irritation)
- Current pregnancy or positive urine pregnancy test (clinical)
- Any neuromodulation therapy (including ECT, rTMS, DBS, VNS, TES) within the last 3 months
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：デバイスの実現可能性
- 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 |
|---|---|
|
実験的：tDCS interventional arm
Participants will receive a 30-minute tDCS treatments at 2 mA twice daily over the course of 5 days. |
tDCS is a form of noninvasive transcranial stimulation of the brain by delivering low-intensity electrical current to the scalp through two electrodes. The Soterix Medical 1×1 Low Intensity Transcranial DC Stimulator Model 1300A (Soterix Medical, Inc., New York, NY, USA) device will be used in the study. The tDCS device is comprised of a small battery-operated control box that delivers the current through electrodes placed on the scalp, held in place by elastic bands or head straps and worn over the forehead like a headband. |
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 |
|---|---|---|
|
Feasibility outcome
時間枠：through study completion, an average of 2 weeks
|
Defined as 70% of eligible patients choosing to enroll in the study. Other feasibility parameters will include willingness of clinicians to refer and help recruit patients, number of eligible participants, willingness of participants to enroll, retention of patients, and completeness of data collection. |
through study completion, an average of 2 weeks
|
|
Acceptability outcome
時間枠：through study completion, an average of 2 weeks
|
Defined as 80% of study participants completing 80% of the 10-session tDCS treatment protocol. Investigators will also ask participants about their satisfaction, perceptions, and experiences with the tDCS treatments. Other acceptability parameters will include rates of adherence to tDCS protocol, dropout rates and reasons for non-completion. |
through study completion, an average of 2 weeks
|
|
Tolerability outcome
時間枠：through study completion, an average of 2 weeks
|
Defined as an overall tolerability rating of "very tolerable." This will be a self-report based on a global question "Considering all aspects of your experience, how would you rate the overall tolerability of the tDCS intervention?" The response options are: very tolerable, somewhat tolerable, neutral, somewhat intolerable, and very intolerable. Other tolerability parameters will include the tDCS adverse effects questionnaire. |
through study completion, an average of 2 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
時間枠：baseline, 2 weeks
|
Measure of depressive symptoms. Response is defined by a 50% or more reduction in MADRS score. The MADRS has 10-items which are based on mood symptoms. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression). |
baseline, 2 weeks
|
|
Change in Snaith-Hamilton Pleasure Scale (SHAPS)
時間枠：baseline, 2 weeks
|
Measure of anhedonia. The SHAPS has 14-items which are based on pleasure symptoms. Each item is scored 1 (definitely agree) to 4 (definitely disagree) with overall score ranges from 14 (experience high pleasure) to 56 (experience low pleasure) |
baseline, 2 weeks
|
|
Change in Stroop Test
時間枠：baseline, 2 weeks
|
Measure of measure memory and executive function. Reaction time (in seconds) in the different conditions of the task (reading the non-conflicting condition, reading the conflicting condition) |
baseline, 2 weeks
|
|
Change in Revised Hopkins Verbal Learning Test (HVLT-R)
時間枠：baseline, 2 weeks
|
Measure of verbal learning and memory. The HVLT-R has 12-items which are based on memory score. Total recall score (range from 0 to 36). The higher the score indicates better short-term memory, lowers scores indicates worse short-term memory. |
baseline, 2 weeks
|
|
Change in Digital Symbol Coding Test (DSCT)
時間枠：baseline, 2 weeks
|
Measure of working memory. The DSST involves a key consisting of the numbers 1-9, each paired with a unique, easy to draw symbol. Below the key are a series of numbers that 1-9 in random order and repeated several times, that are to be filled in the corresponding symbol for each number. One point is given for each correct response. Total scores range from 0-9, lower scores indicate worse memory; higher scores indicate better memory. |
baseline, 2 weeks
|
|
Change in Peak alpha frequency (PAF)
時間枠：baseline, 2 weeks
|
EEG measure of the highest magnitude within the alpha range of brain oscillations, thought to reflect cognitive performance. |
baseline, 2 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Maria I Lapid, MD、Mayo Clinic
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 (実際)
一次修了 (実際)
研究の完了 (推定)
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 (実際)
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
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