Effektivitet og sikkerhet for magnetisk resonansavbildningsstyrt repeterende transkraniell magnetisk stimulering (RTMS) hos ungdom med depresjon: en randomisert, dobbeltblind, kontrollert pilotstudie
20. mai 2026 oppdatert av: Xinyu Zhou, First Affiliated Hospital of Chongqing Medical University
Denne studien tar sikte på å vurdere gjennomførbarhet, sikkerhet, akseptabilitet og foreløpige effektivitetstrender for en magnetisk resonansavbildningsstyrt repeterende transkraniell magnetisk stimulering (RTMS) intervensjon for ungdomsdepresjon gjennom en pilot klinisk studie.
Funnene vil informere om utforming og optimalisering av påfølgende formelle randomiserte kontrollerte studier, og gi viktig bevis for utførelsen.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
Denne studien er en randomisert, dobbeltblind, kontrollert pilotforsøk som tar sikte på å evaluere gjennomførbarhet, sikkerhet, akseptabilitet og foreløpige effekttrender for magnetisk resonansavbildningsstyrt repetitiv transkraniell magnetisk stimulering (RTMS) for behandling av ungdoms depresjon.
Ungdom som er diagnostisert med Major Depressive Disorder (MDD) vil bli tilfeldig tildelt i et forhold på 1: 1: 1 og en av tre grupper: den eksperimentelle mål -RTMS -behandlingsgruppen, den konvensjonelle målet RTMS -behandlingsgruppen og SHAM -stimuleringsgruppen. Alle tre gruppene vil motta 4 uker med RTMS-stimulering (10 Hz, 120% RMT) eller Sham-stimuleringsintervensjon, ved bruk av Blackdolphin TMS-robot (SLD-Yxrj) av Xi'an Solide Brain Modulation Ltd. Co., med 20 økter (administrert på hverdager) totalt. Intervensjonsfrekvensen og prosedyren vil forbli konsistent i alle grupper.
I den eksperimentelle målet RTMS-behandlingsgruppen vil deltakerne gjennomgå MR-guidet identifisering av det venstre dorsolaterale prefrontale cortex (DLPFC) -regionen, der voxel som er mest negativt korrelert med den funksjonelle tilkoblingen til den subgenale fremre cingulate cortex (SGACC) vil tjene som stimuleringsmålet. I den konvensjonelle Target RTMS -behandlingsgruppen vil deltakerne ha standard F3 -mål i DLPFC identifisert via MR -veiledning som stimuleringssted. Deltakere i SHAM -stimuleringsgruppen vil motta en placebo -behandling, og simulere RTMS -prosedyren uten å generere en effektiv magnetfeltutgang.
Det primære utfallet av behandlingsfasen er effektivitetsraten eller remisjonen for depressive symptomer. Sekundære utfall inkluderer symptomskalaer, angstsymptomer, selvmordsrisiko, livskvalitet, søvn, drøvtygging og kognisjon. Sikkerhet vil bli overvåket gjennom bivirkninger, vitale tegn, laboratorietester og tolerabilitetsvurderinger.
Studietype
Intervensjonell
Registrering (Antatt)
45
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Xinyu Zhou
- Telefonnummer: 15823996993
- E-post: zhouxinyu@cqmu.edu.cn
Studiesteder
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Chongqing, Kina
- Rekruttering
- The First Affiliated Hospital of Chongqing Medical University
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Ta kontakt med:
- Xinyu Zhou
- Telefonnummer: 15823996993
- E-post: zhouxinyu@cqmu.edu.cn
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inkluderingskriterier:
- Alder 12 - 18
- Diagnostisering av Major Depressive Disorder (MDD) i henhold til diagnostisk og statistisk manual for psykiske lidelser, Fifth Edition (DSM-5), bekreftet gjennom Kiddie-planen for affektive lidelser og schizofreni-nåtid og livstidsversjon (K-SADS-PL), for tiden i en depressiv episode
- Score ≥40 på CDRS-R
- Stabil farmakologisk behandling: Minst 4 ukers stabil psykiatrisk medisinering før påmelding, med fortsettelse av det samme psykiatriske medisineringsregimet gjennom hele studien.
Eksklusjonskriterier:
- Psykiatriske komorbiditeter enn angstlidelser
- Depresjon med psykotiske symptomer
- Young Mania Rating Scale (YMRS) Score> 13
- En historie med nevrologiske lidelser (f.eks. Epilepsi, hjerneskade) eller alvorlige somatiske sykdommer (f.eks. Skjoldbruskkjertelforstyrrelser, lupus, diabetes, lunge, lever eller nyrefunksjon, større traumer)
- Pasienter som for tiden bruker krampestillende midler eller høydose benzodiazepiner
- En historie med elektrokonvulsiv terapi (ECT), transkraniell magnetisk stimulering (TMS), transkraniell likestrømstimulering (TDC), transkraniell vekselstrømstimulering (TACS) eller andre neuromodulasjonsbehandlinger
- En historie med alkohol eller rus eller avhengighet
- Kvinner som er gravide eller ammes
- Nåværende høy selvmordsrisiko
- Potensielle kompliserende faktorer relatert til transkraniell magnetisk stimulering, for eksempel hodebunnsbetingelser eller perforeringer som kan påvirke levering av magnetfelt
- Kontraindikasjoner for MR
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Eksperimentelt mål RTMS behandlingsgruppe
Deltakerne vil gjennomgå MR-guidet identifisering av voxel i venstre dorsolateral prefrontal cortex (DLPFC) som er mest negativt korrelert med den funksjonelle tilkoblingen til den subgenuelle fremre cingulate cortex (SGACC) som stimuleringsstedet.
Repeterende transkraniell magnetisk stimulering (RTMS) (10 Hz, 120% RMT) vil bli administrert ved bruk av BlackDolphin TMS Robot Device (Model SLD-Yxrj) av Xi'an Solide Brain Modulation Ltd.
Co., med 20 økter over 4 uker (behandling administrert på hverdager).
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Deltakerne vil gjennomgå MR-guidet identifisering av voxel i venstre dorsolateral prefrontal cortex (DLPFC) som er mest negativt korrelert med den funksjonelle tilkoblingen til den subgenuelle fremre cingulate cortex (SGACC) som stimuleringsstedet.
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Sham-komparator: Skamstimulering av behandlingsgruppe
Deltakerne vil motta en skamstimuleringsbehandling designet for å simulere RTMS -prosedyren uten å generere en effektiv magnetfeltutgang.
Intervensjonen vil bruke en dedikert skamstimuleringsspole, som er identisk i utseende, drift og stimuleringsprotokoll til den eksperimentelle gruppen.
Denne spolen er designet for å opprettholde de samme auditive og taktile sensasjonene som den aktive stimuleringen, men er utstyrt med en elektromagnetisk skjermingstruktur eller et internt omvendt spolearrangement for effektivt å forhindre magnetisk fluks fra å trenge gjennom skallen, noe som ikke sikrer noen faktiske nevromodulerende effekter.
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Deltakerne vil motta en skamstimuleringsbehandling designet for å simulere RTMS -prosedyren uten å generere en effektiv magnetfeltutgang.
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Eksperimentell: Konvensjonell målrettet rTMS-behandlingsgruppe
Deltakerne vil motta MR-veiledet stimulering ved den venstre DLPFC-lokasjonen.
Repetitiv transkraniell magnetisk stimulering (rTMS) (10 Hz, 120% RMT) vil bli administrert ved hjelp av Blackdolphin TMS Robot-enheten (modell SLD-YXRJ) fra Xi'an Solide Brain Modulation Ltd.
Co., med 20 økter over 4 uker (behandling administrert på hverdager).
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deltakerne vil motta MRI-veiledet stimulering på venstre DLPFC-plassering.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Recruitment Feasibility (Number of Participants Enrolled)
Tidsramme: 2 years
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The total number of participants successfully enrolled in this study will be recorded to assess recruitment feasibility.
The goal is to recruit 45 participants (15 in each of the three groups) over a 2-year period.
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2 years
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Intervention adherence (number of participants who completed the full 20 treatment sessions)
Tidsramme: Throughout the entire course of treatment (up to 1 month)
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This outcome measure will assess participants' adherence to the 20 sessions of transcranial magnetic stimulation.
Adherence is defined as completing all 20 sessions.
Adherence is calculated by dividing the number of participants who met this criterion by the total number of participants.
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Throughout the entire course of treatment (up to 1 month)
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Retention Rate (Number of Participants Remaining at 6-Month Follow-up)
Tidsramme: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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This outcome measure will assess the proportion of participants still enrolled in the study at the 6-month follow-up assessment.
Retention rate is calculated as the number of participants who completed the 6-month assessment divided by the number of participants enrolled at baseline.
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Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Response rate and remission rate of depressive symptoms
Tidsramme: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Preliminary clinical efficacy will be assessed by change in the Children's Depression Rating Scale-Revised (CDRS-R) total score from baseline.
CDRS-R is a clinician-rated scale used to assess the severity of depressive symptoms in children and adolescents.
It consists of 17 items, and the total score ranges from 17 to 113.
Higher scores indicate more severe depressive symptoms.
Changes in CDRS-R total score from baseline will be assessed at the end of treatment and at follow-up visits.
Response rate of depressive symptoms will be defined as a ≥50% reduction in CDRS-R total score from baseline, and remission rate of depressive symptoms will be defined as a CDRS-R total score ≤28.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Incidence of Adverse Events and Serious Adverse Events
Tidsramme: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Adverse events, abbreviated as AEs, and serious adverse events, abbreviated as SAEs, will be assessed to evaluate the safety and tolerability of the intervention.
An AE is defined as any unfavorable medical occurrence in a participant during the study period, regardless of whether it is considered related to the intervention.
An SAE is defined as any adverse event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is otherwise considered medically significant.
The number and proportion of participants experiencing at least one AE or SAE will be recorded throughout the study period.
The severity, outcome, and relationship to the intervention will also be documented.
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Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in BDI-II (Beck Depression Inventory-II) scores from baseline
Tidsramme: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Beck Depression Inventory-II, abbreviated as BDI-II, is a 21-item self-report scale used to measure the severity of depressive symptoms.
Each item is scored from 0 to 3, and the total score ranges from 0 to 63.
Higher scores indicate more severe depressive symptoms.
Changes in BDI-II total score from baseline will be assessed at the end of treatment and at follow-up visits.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in HAMA score from baseline
Tidsramme: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Hamilton Anxiety Rating Scale, abbreviated as HAMA, is a clinician-rated scale used to assess the severity of anxiety symptoms.
It consists of 14 items covering both psychic anxiety and somatic anxiety symptoms.
Each item is scored from 0 to 4, and the total score ranges from 0 to 56.
Higher scores indicate more severe anxiety symptoms.
Changes in HAMA total score from baseline will be assessed at the end of treatment and at follow-up visits.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline
Tidsramme: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Screen for Child Anxiety Related Emotional Disorders, abbreviated as SCARED, is a self-report scale used to assess anxiety symptoms in children and adolescents.
The total score ranges from 0 to 82, with higher scores indicating more severe anxiety symptoms.
The change in SCARED total score from baseline will be calculated at each post-baseline assessment time point.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)
Tidsramme: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Columbia-Suicide Severity Rating Scale, abbreviated as C-SSRS, is a clinician-administered scale used to assess suicidal ideation and suicidal behavior.
The C-SSRS Suicidal Ideation Severity Score ranges from 0 to 5, where 0 indicates no suicidal ideation and higher scores indicate more severe suicidal ideation.
The change in C-SSRS Suicidal Ideation Severity Score from baseline will be calculated at each post-baseline assessment time point.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline
Tidsramme: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Pittsburgh Sleep Quality Index, abbreviated as PSQI, is a self-report questionnaire used to assess sleep quality and sleep disturbances over the past month.
The 19 self-rated items are used to generate seven component scores, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Each component score ranges from 0 to 3, and the global PSQI score ranges from 0 to 21.
Higher scores indicate poorer sleep quality.
Changes in the global PSQI score from baseline will be assessed at the end of treatment and at follow-up visits.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline
Tidsramme: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Clinical Global Impression-Severity scale, abbreviated as CGI-S, is a clinician-rated scale used to assess the overall severity of illness at the time of evaluation.
It is rated on a 7-point scale, ranging from 1 = normal, not at all ill to 7 = among the most extremely ill patients.
Higher scores indicate greater illness severity.
Changes in CGI-S score from baseline will be assessed at the end of treatment and at follow-up visits.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline
Tidsramme: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Clinical Global Impression-Improvement scale, abbreviated as CGI-I, is a clinician-rated scale used to assess the overall change in a participant's clinical condition compared with baseline.
It is rated on a 7-point scale, ranging from 1 = very much improved to 7 = very much worse.
Lower scores indicate greater clinical improvement.
CGI-I scores will be assessed at the end of treatment and at follow-up visits.
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Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in RRS (Ruminative Responses Scale)
Tidsramme: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Ruminative Responses Scale, abbreviated as RRS, is a self-report scale used to assess the tendency to engage in ruminative thinking in response to depressed mood.
The full version consists of 22 items, and each item is rated on a 4-point scale, ranging from 1 to 4. The total score ranges from 22 to 88.
Higher scores indicate greater levels of rumination.
Changes in RRS total score from baseline will be assessed at the end of treatment and at follow-up visits.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Change in PedsQL 4.0 score from baseline
Tidsramme: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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The Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, abbreviated as PedsQL 4.0, is a standardized questionnaire used to assess health-related quality of life in children and adolescents.
It consists of 23 items covering four domains: physical functioning, emotional functioning, social functioning, and school functioning.
Raw item scores are reverse-scored and linearly transformed to a 0 to 100 scale, with 0=100, 1=75, 2=50, 3=25, and 4=0.
The total scale score is calculated as the mean of all answered items, with higher scores indicating better health-related quality of life.
Changes in PedsQL 4.0 total score from baseline will be assessed at the end of treatment and at follow-up visits.
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Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
- March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J; Treatment for Adolescents With Depression Study (TADS) Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA. 2004 Aug 18;292(7):807-20. doi: 10.1001/jama.292.7.807.
- O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
- Allen CH, Kluger BM, Buard I. Safety of Transcranial Magnetic Stimulation in Children: A Systematic Review of the Literature. Pediatr Neurol. 2017 Mar;68:3-17. doi: 10.1016/j.pediatrneurol.2016.12.009. Epub 2017 Jan 4.
- Hetrick SE, McKenzie JE, Bailey AP, Sharma V, Moller CI, Badcock PB, Cox GR, Merry SN, Meader N. New generation antidepressants for depression in children and adolescents: a network meta-analysis. Cochrane Database Syst Rev. 2021 May 24;5(5):CD013674. doi: 10.1002/14651858.CD013674.pub2.
- Brent D, Emslie G, Clarke G, Wagner KD, Asarnow JR, Keller M, Vitiello B, Ritz L, Iyengar S, Abebe K, Birmaher B, Ryan N, Kennard B, Hughes C, DeBar L, McCracken J, Strober M, Suddath R, Spirito A, Leonard H, Melhem N, Porta G, Onorato M, Zelazny J. Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial. JAMA. 2008 Feb 27;299(8):901-913. doi: 10.1001/jama.299.8.901.
- Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
- Croarkin PE, Elmaadawi AZ, Aaronson ST, Schrodt GR Jr, Holbert RC, Verdoliva S, Heart KL, Demitrack MA, Strawn JR. Left prefrontal transcranial magnetic stimulation for treatment-resistant depression in adolescents: a double-blind, randomized, sham-controlled trial. Neuropsychopharmacology. 2021 Jan;46(2):462-469. doi: 10.1038/s41386-020-00829-y. Epub 2020 Sep 12.
- Sigrist C, Vockel J, MacMaster FP, Farzan F, Croarkin PE, Galletly C, Kaess M, Bender S, Koenig J. Transcranial magnetic stimulation in the treatment of adolescent depression: a systematic review and meta-analysis of aggregated and individual-patient data from uncontrolled studies. Eur Child Adolesc Psychiatry. 2022 Oct;31(10):1501-1525. doi: 10.1007/s00787-022-02021-7. Epub 2022 Jun 24.
- Berlim MT, Van den Eynde F, Daskalakis ZJ. Efficacy and acceptability of high frequency repetitive transcranial magnetic stimulation (rTMS) versus electroconvulsive therapy (ECT) for major depression: a systematic review and meta-analysis of randomized trials. Depress Anxiety. 2013 Jul;30(7):614-23. doi: 10.1002/da.22060. Epub 2013 Jan 24.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. september 2025
Primær fullføring (Antatt)
15. september 2027
Studiet fullført (Antatt)
30. desember 2027
Datoer for studieregistrering
Først innsendt
15. september 2025
Først innsendt som oppfylte QC-kriteriene
15. september 2025
Først lagt ut (Faktiske)
22. september 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1stChongqingCQMU___ZXY
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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Nei
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