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Effektivitet og sikkerhed ved magnetisk resonansafbildning-styret gentagen transkranial magnetisk stimulering (RTMS) hos unge med depression: en randomiseret, dobbeltblind, kontrolleret pilotundersøgelse

20. maj 2026 opdateret af: Xinyu Zhou, First Affiliated Hospital of Chongqing Medical University
Denne undersøgelse sigter mod at vurdere gennemførligheden, sikkerhed, acceptabilitet og foreløbig effektivitetstendenser for en magnetisk resonansbillede-guidet gentagen transkranial magnetisk stimulering (RTMS) intervention til ungdomsdepression gennem et klinisk pilotforsøg. Resultaterne vil informere design og optimering af efterfølgende formelle randomiserede kontrollerede forsøg, hvilket giver vigtige beviser for deres udførelse.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Denne undersøgelse er en randomiseret, dobbeltblind, kontrolleret pilotforsøg med det formål at evaluere gennemførligheden, sikkerhed, acceptabilitet og foreløbig effektivitetstendenser for magnetisk resonansafbildning-guidet gentagen transkranial magnetisk stimulering (RTMS) til behandling af ungdomsdepression.

Ungdom, der er diagnosticeret med større depressiv lidelse (MDD), tildeles tilfældigt i et forhold på 1: 1: 1 til en af ​​tre grupper: den eksperimentelle mål RTMS -behandlingsgruppe, den konventionelle mål RTMS -behandlingsgruppe og Sham -stimuleringsgruppen. Alle tre grupper får 4 ugers RTMS-stimulering (10 Hz, 120% RMT) eller skamstimuleringsintervention ved hjælp af Blackdolphin TMS-robot (SLD-YXRJ) af Xi'an Solide Brain Modulation Ltd. Co., med 20 sessioner (administreret på hverdage) i alt. Interventionsfrekvensen og proceduren forbliver konsistent på tværs af alle grupper.

I den eksperimentelle mål RTMS-behandlingsgruppe vil deltagerne gennemgå MRI-styret identifikation af den venstre dorsolaterale præfrontale cortex (DLPFC) -region, hvor den Voxel mest negativt korreleret med den funktionelle forbindelse af den subgenuelle anterior cingulate cortex (SGACC) vil tjene som stimuleringsmålet. I den konventionelle mål RTMS -behandlingsgruppe vil deltagerne have standard F3 -målet i DLPFC identificeret via MRI -vejledning som stimuleringsstedet. Deltagere i skamstimuleringsgruppen vil modtage en placebo -behandling, der simulerer RTMS -proceduren uden at generere et effektivt magnetfeltudgang.

Det primære resultat af behandlingsfasen er effektivitetshastigheden eller remissionshastigheden for depressive symptomer. Sekundære resultater inkluderer symptomskalaer, angstsymptomer, selvmordsrisiko, livskvalitet, søvn, drøvtyggelse og kognition. Sikkerhed overvåges gennem bivirkninger, vitale tegn, laboratorieundersøgelser og tolerabilitetsvurderinger.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

45

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Chongqing, Kina
        • Rekruttering
        • The First Affiliated Hospital of Chongqing Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inkluderingskriterier:

  1. Alder 12 - 18
  2. Diagnose af større depressiv lidelse (MDD) ifølge Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), bekræftet gennem kiddie-skemaet for affektive lidelser og skizofreni-nuværende og livstidsversion (K-SADS-PL), der i øjeblikket er i en depressiv episode
  3. Score ≥40 på CDRS-R
  4. Stabil farmakologisk behandling: Mindst 4 ugers stabil brug af psykiatrisk medicin inden tilmelding med fortsættelse af det samme psykiatriske medicinregime gennem hele undersøgelsen.

Ekskluderingskriterier:

  1. Psykiatriske komorbiditeter bortset fra angstlidelser
  2. Depression med psykotiske symptomer
  3. Young Mania Rating Scale (YMRS) score> 13
  4. En historie med neurologiske lidelser (f.eks. Epilepsi, hjerneskade) eller alvorlige somatiske sygdomme (f.eks. Skjoldbruskkirtelforstyrrelser, lupus, diabetes, pulmonal, lever- eller nyrefunktion, større traumer)
  5. Patienter, der i øjeblikket bruger antikonvulsiva eller højdosis benzodiazepiner
  6. En historie med elektrokonvulsiv terapi (ECT), transkranial magnetisk stimulering (TMS), transkranial jævnstrømstimulering (TDC'er), transkranial vekslende strømstimulering (TACS) eller andre neuromodulationsbehandlinger
  7. En historie med alkohol eller stofmisbrug eller afhængighed
  8. Kvinder, der er gravide eller ammer
  9. Nuværende høj selvmordsrisiko
  10. Potentielle komplicerende faktorer relateret til transkranial magnetisk stimulering, såsom hovedbundsbetingelser eller perforeringer, der kan påvirke magnetfeltlevering
  11. Kontraindikationer til MR

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Eksperimentel mål RTMS -behandlingsgruppe
Deltagerne vil gennemgå MRI-styret identifikation af voxel i den venstre dorsolaterale præfrontale cortex (DLPFC), der er mest negativt korreleret med den funktionelle forbindelse af den subgeniske anterior cingulate cortex (SGACC) som stimuleringsstedet. Gentagende transkranial magnetisk stimulering (RTMS) (10 Hz, 120% RMT) administreres ved hjælp af Blackdolphin TMS-robotenheden (Model SLD-YXRJ) af Xi'an Solide Brain Modulation Ltd. Co., med 20 sessioner over 4 uger (behandling administreret på hverdage).
Enhed: Eksperimentel mål RTMS -behandling
Deltagerne vil gennemgå MRI-styret identifikation af voxel i den venstre dorsolaterale præfrontale cortex (DLPFC), der er mest negativt korreleret med den funktionelle forbindelse af den subgeniske anterior cingulate cortex (SGACC) som stimuleringsstedet.
Sham-komparator: Skamstimuleringsbehandlingsgruppe
Deltagerne vil modtage en skamstimuleringsbehandling designet til at simulere RTMS -proceduren uden at generere et effektivt magnetfeltudgang. Interventionen vil bruge en dedikeret skamstimuleringsspole, som er identisk i udseende, drift og stimuleringsprotokol til den eksperimentelle gruppe. Denne spole er designet til at opretholde de samme auditive og taktile fornemmelser som den aktive stimulering, men er udstyret med en elektromagnetisk afskærmningsstruktur eller en intern omvendt spolearrangement for effektivt at forhindre magnetisk flux i at trænge ind i kraniet, hvilket ikke sikrer nogen faktiske neuromodulerende effekter.
Enhed: Skamstimuleringsbehandling
Deltagerne vil modtage en skamstimuleringsbehandling designet til at simulere RTMS -proceduren uden at generere et effektivt magnetfeltudgang.
Eksperimentel: Konventionel målrettet rTMS-behandlingsgruppe
Deltagerne vil modtage MRI-vejledet stimulering ved den venstre DLPFC-lokalisering. Repetitiv transkraniel magnetisk stimulering (rTMS) (10 Hz, 120% RMT) vil blive administreret ved hjælp af Blackdolphin TMS Robot-enheden (model SLD-YXRJ) fra Xi'an Solide Brain Modulation Ltd. Co., med 20 sessioner over 4 uger (behandling administreret på hverdage).
Enhed: Konventionel målrettet rTMS-behandling
deltagerne vil modtage MRI-vejledt stimulering ved den venstre DLPFC-lokation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment Feasibility (Number of Participants Enrolled)
Tidsramme: 2 years
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.
2 years
Intervention adherence (number of participants who completed the full 20 treatment sessions)
Tidsramme: Throughout the entire course of treatment (up to 1 month)
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.
Throughout the entire course of treatment (up to 1 month)
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)
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.
Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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)
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.
Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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)
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.
Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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)
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.
Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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)
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.
Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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)
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.
Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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)
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.
Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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)
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.
Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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)
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.
Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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)
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.
Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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)
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.
Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)
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)
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.
Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. september 2025

Primær færdiggørelse (Anslået)

15. september 2027

Studieafslutning (Anslået)

30. december 2027

Datoer for studieregistrering

Først indsendt

15. september 2025

Først indsendt, der opfyldte QC-kriterier

15. september 2025

Først opslået (Faktiske)

22. september 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1stChongqingCQMU___ZXY

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