UMIN試験ID | UMIN000055955 |
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受付番号 | R000063946 |
科学的試験名 | |
一般公開日(本登録希望日) | 2024/10/28 |
最終更新日 | 2024/10/27 10:52:51 |
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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
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英語
Antidepressant efficacy of piTBS, rTMS, and sham
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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
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英語
Antidepressant efficacy of piTBS, rTMS, and sham
アジア(日本以外)/Asia(except Japan) |
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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.
精神神経科学/Psychiatry |
悪性腫瘍以外/Others
いいえ/NO
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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.
有効性/Efficacy
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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).
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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)
介入/Interventional
並行群間比較/Parallel
ランダム化/Randomized
集団/Cluster
二重盲検/Double blind -all involved are blinded
プラセボ・シャム対照/Placebo
いいえ/NO
いいえ/NO
施設を考慮していない/Institution is not considered as adjustment factor.
3
治療・ケア/Treatment
医療器具・機器/Device,equipment |
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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)
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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)
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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)
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21 | 歳/years-old | 以上/<= |
70 | 歳/years-old | 以下/>= |
男女両方/Male and Female
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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.
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(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)
60
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名 | |
ミドルネーム | |
姓 |
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名 | Cheng-Ta |
ミドルネーム | |
姓 | Li |
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Taipei Veterans General Hospital, Taipei, Taiwan
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Department of Psychiatry
112
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No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan
+886-2-28757027
on5083@msn.com
日本語
名 | |
ミドルネーム | |
姓 |
英語
名 | Cheng-Ta |
ミドルネーム | |
姓 | Li |
日本語
英語
Taipei Veterans General Hospital, Taipei, Taiwan
日本語
英語
Department of Psychiatry
112
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英語
No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan
+886-2-28757027
on5083@msn.com
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その他
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Taipei Veterans General Hospital, Taipei, Taiwan
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その他
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Taipei Veterans General Hospital, Taipei, Taiwan
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海外/Outside Japan
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Institutional Review Board, Taipei Veterans General Hospital, Taipei, Taiwan
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NO.201, SEC. 2, SHIPAI RD, Taipei City, Taiwan
886-2-2875-7384
irbopinion@vghtpe.gov.tw
いいえ/NO
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2024 | 年 | 10 | 月 | 28 | 日 |
未公表/Unpublished
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限定募集中/Enrolling by invitation
2024 | 年 | 08 | 月 | 01 | 日 |
2024 | 年 | 09 | 月 | 13 | 日 |
2024 | 年 | 10 | 月 | 28 | 日 |
2026 | 年 | 10 | 月 | 28 | 日 |
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2024 | 年 | 10 | 月 | 27 | 日 |
2024 | 年 | 10 | 月 | 27 | 日 |
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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
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