UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語

英語
Comparisons of Prefrontal Inhibition and Excitation Between Prefrontal Intermittent Theta-Burst Stimulation and 10-Hz Repetitive Transcranial Magnetic Stimulation for Treating Refractory Depression: A Sham-Control Neuroimaging Study

一般向け試験名略称/Acronym

日本語

英語
Antidepressant efficacy of piTBS, rTMS, and sham

科学的試験名/Scientific Title

日本語

英語
Comparisons of Prefrontal Inhibition and Excitation Between Prefrontal Intermittent Theta-Burst Stimulation and 10-Hz Repetitive Transcranial Magnetic Stimulation for Treating Refractory Depression: A Sham-Control Neuroimaging Study

科学的試験名略称/Scientific Title:Acronym

日本語

英語
Antidepressant efficacy of piTBS, rTMS, and sham

試験実施地域/Region

アジア（日本以外）/Asia(except Japan)

対象疾患名/Condition

日本語

英語
The evidence so far suggests that inhibitory function, such as GABAa-receptor-related and GABAb-receptor-related inhibitory function in the DLPFC, is key to treatment responses in MDD. Prolonged intermittent theta-burst stimulation(piTBS) could be effective through the modulation of prefrontal excitatory and inhibitory function. In addition, previous literature provided the evidence that 2-weeks left-sided DLPFC-piTBS had similar antidepressant efficacy with the 4-6weeks standard left-sided DLPFC-10HzrTMS. However, the following questions remain to be answered: (1)4-weeks left-sided DLPFC-piTBS could provide better antidepressant efficacy than 4-weeks left-sided DLPFC-10HzrTMS; (2)the potentially different effects of 4-weeks piTBS and rTMS on PFC inhibitory functions, and (3) the identification of reliable biomarkers, including EEG signals, that could reliably predict the antidepressant effects of 4-weeks rTMS/piTBS intervention.

疾患区分1/Classification by specialty

精神神経科学/Psychiatry

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語

英語
The purpose of this study is to evaluate the antidepressant efficacy of 4-weeks prolonged intermittent theta-burst stimulation (piTBS) and clarify the neruoplasticity effects of different TMS parameters, such as iTBS and rTMS,by evaluating their prefrontal excitatory/inhibitory function and brain glucose metabolism in patients with treatment-resistant depression, and to identify biomarkers that can predict antidepressant effects. This will assist clinicians in selecting stimulation treatment parameters and improving response rates.

目的2/Basic objectives2

有効性/Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語

英語
Improvement in depression severity, measured by a percentage change in 17-items Hamilton Depression Rating Scale(HDRS-17) score (% HDRS-17) before and after 4 weeks of brain stimulation treatment between the three groups (piTBS,10HzrTMS and sham).

副次アウトカム評価項目/Key secondary outcomes

日本語

英語
1. The response rate (defined as a >= 50% reduction compared with the baseline HDRS-17 score) and the remission rate (defined as an HDRS-17 score <= 7).
2. Safety
3. the changes of TMS-EEG parameters before and after 4 weeks of brain stimulation treatment between the three groups (piTBS,10HzrTMS and sham)
4. the changes of regional brain glucose metabolism before and after 4 weeks of brain stimulation treatment between the three groups (piTBS,10HzrTMS and sham)
5. the changes of prefrontal EEG before and after 4 weeks of brain stimulation treatment between the three groups (piTBS,10HzrTMS and sham)
6. the changes of cognitive function, measured by Test of Attentional Performance and Go-Nogo test, before and after 4 weeks of brain stimulation treatment between the three groups (piTBS,10HzrTMS and sham)
7. the changes of functional connectivities before and after 4 weeks of brain stimulation treatment between the three groups (piTBS,10HzrTMS and sham)
8. the correlation between antidepressant efficacy and baseline prefrontal function, measured by EEG, TMS-EEG indices and glucose metabolism and functional connectivities and EEG.
9. the correlation between antidepressant efficacy and baseline mood-related brain area, measured by glucose metabolism and functional connectivities.
10. the correlation between antidepressant efficacy and the changes of glucose metabolism and functional connectivities on the mood-related brain area.
11. the correlation between antidepressant efficacy and the changes of TMS-EEG and EEG indices on prefrontal cortex.
12. the correlation between antidepressant efficacy and patients' characteristic (e.g., treatment refractoriness)

試験の種類/Study type

介入/Interventional

基本デザイン/Basic design

並行群間比較/Parallel

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

集団/Cluster

ブラインド化/Blinding

二重盲検/Double blind -all involved are blinded

コントロール/Control

プラセボ・シャム対照/Placebo

層別化/Stratification

いいえ/NO

動的割付/Dynamic allocation

いいえ/NO

試験実施施設の考慮/Institution consideration

施設を考慮していない/Institution is not considered as adjustment factor.

ブロック化/Blocking

割付コードを知る方法/Concealment

群数/No. of arms

3

介入の目的/Purpose of intervention

治療・ケア/Treatment

介入の種類/Type of intervention

医療器具・機器/Device,equipment

介入1/Interventions/Control_1

日本語

英語
Group A (piTBS group): A three-pulse 50Hz wave delivered every 200ms at 80% active motor threshold, with stimulation for 2 seconds followed by an 8-second rest, for 60 cycles, totaling 1800 pulses/session, for a total of 20 sessions(4 weeks)

介入2/Interventions/Control_2

日本語

英語
Group B (10Hz rTMS group): 10Hz at 120% resting motor threshold, with stimulation for 4 seconds followed by a 16-second rest, for 75 cycles, totaling 3000 pulses/session, for a total of 20 sessions(4 weeks)

介入3/Interventions/Control_3

日本語

英語
Sham group: half of the patients following the parameters of Group A and the other half following the parameters of Group B, but stimulated by standard sham coil (Magstim(R)), for a total of 20 sessions(4 weeks)

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

21

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

70

歳/years-old

以下/>=

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語

英語
The diagnosis of recurrent MDD is based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (American Psychiatric Association, 1994).

Patients qualified to participate in the study if they failed to respond to at least 1 adequate antidepressant treatment for their current episode (e.g., failed to achieve 50% improvement in depression to an equivalent daily dose of 10-20 mg of escitalopram for at least 8 weeks).

MDD patients would be recruited only if the score of the 17-item Hamilton Depression Rating Scale (HDRS-17) is 18 or more and the score of a Clinical Global Impression Severity is 4 or more.

All participants were on stable antidepressant regimens or no antidepressant therapy for at least 4 weeks prior to this trial.

除外基準/Key exclusion criteria

日本語

英語
(1)A lifetime psychiatric diagnosis of psychotic disorder, bipolar disorder, organic mental disorder, substance use disorder (based on DSM-IV criteria), and a lifetime medical history of major systemic illness and neurological disorder records(e.g., seizure, cerebrovascular disease, stroke, meningitis and traumatic brain injury)
(2)A history of brain surgery, brain implants (e.g., neurostimulators, clip), and cardiac pacemakers and any mental device or implant in the body (e.g. neurostimulators, electrodes, cochlear implant)
(3)Any major brain organic insults (e.g., brain arteriovenous malformation, cerebral aneurysm, primary or secondary tumors in central nervous system)
(4)Having active suicidal intent, or high suicidality if score of the third item of HDRS-17 is 4 in recent one week.
(5)Women in pregnancy.
(6)Claustrophobia: people cannot stay in a closed environment (e.g., MRI scan)
(7)Presence of any other condition that has the potential to prevent study completion or may confound the outcome assessments (e.g. refusal to sign the informed consent, no meet the inclusion criteria after recruitment)

目標参加者数/Target sample size

60

責任研究者/Name of lead principal investigator

日本語

名
ミドルネーム
姓

英語

名	Cheng-Ta
ミドルネーム
姓	Li

所属組織/Organization

日本語

英語
Taipei Veterans General Hospital, Taipei, Taiwan

所属部署/Division name

日本語

英語
Department of Psychiatry

郵便番号/Zip code

112

住所/Address

日本語

英語
No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan

電話/TEL

+886-2-28757027

Email/Email

on5083@msn.com

試験問い合わせ窓口担当者/Name of contact person

日本語

名
ミドルネーム
姓

英語

名	Cheng-Ta
ミドルネーム
姓	Li

組織名/Organization

日本語

英語
Taipei Veterans General Hospital, Taipei, Taiwan

部署名/Division name

日本語

英語
Department of Psychiatry

郵便番号/Zip code

112

住所/Address

日本語

英語
No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan

電話/TEL

+886-2-28757027

試験のホームページURL/Homepage URL

Email/Email

on5083@msn.com

機関名/Institute

日本語
その他

英語
Taipei Veterans General Hospital, Taipei, Taiwan

機関名/Institute
（機関選択不可の場合）

日本語

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
Taipei Veterans General Hospital, Taipei, Taiwan

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

組織の区分/Category of Funding Organization

海外/Outside Japan

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語

英語
Institutional Review Board, Taipei Veterans General Hospital, Taipei, Taiwan

住所/Address

日本語

英語
NO.201, SEC. 2, SHIPAI RD, Taipei City, Taiwan

電話/Tel

886-2-2875-7384

Email/Email

irbopinion@vghtpe.gov.tw

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2024

年

10

月

28

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

組み入れ参加者数/Number of participants that the trial has enrolled

主な結果/Results

日本語

英語

主な結果入力日/Results date posted

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語

英語

参加者の流れ/Participant flow

日本語

英語

有害事象/Adverse events

日本語

英語

評価項目/Outcome measures

日本語

英語

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

限定募集中/Enrolling by invitation

プロトコル確定日/Date of protocol fixation

2024

年

08

月

01

日

倫理委員会による承認日/Date of IRB

2024

年

09

月

13

日

登録・組入れ開始（予定）日/Anticipated trial start date

2024

年

10

月

28

日

フォロー終了(予定)日/Last follow-up date

2026

年

10

月

28

日

入力終了(予定)日/Date of closure to data entry

データ固定（予定）日/Date trial data considered complete

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語

英語

登録日時/Registered date

2024

年

10

月

27

日

最終更新日/Last modified on

2024

年

10

月

27

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000063946

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063946