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Multimål transkraniel jævnstrømsstimulering for komorbid depression og kronisk smerte: Et multicenter randomiseret kontrolleret forsøg

1. september 2026 opdateret af: Shanghai Mental Health Center

Transkraniel Elektrisk Stimulering for Komorbid Depression og Smerte: Fra Teknologisk Udvikling til Klinisk Oversættelse i et Multicenter Studie

Dette kliniske forsøg har til formål at undersøge en ny ikke-farmakologisk intervention, transkraniel jævnstrømsstimulering (tDCS), til behandling af komorbid depression og smerte. De primære mål er at optimere neurostimulationsparametre gennem et multicenter, randomiseret kontrolleret design og at belyse de underliggende neurale kredsløb-immun interaktionsmekanismer for denne komorbiditet. Deltagere med komorbid depression og kroniske smerter vil blive tilfældigt tildelt til at modtage aktiv multi-target tES eller placebo-stimulering. Interventionsperioden vil vare i 2 uger, efterfulgt af en række efterbehandlingsopfølgende vurderinger. Forskerne vil sammenligne ændringerne i depressionssværhedsgrad (f.eks. vurderet ved HAMD-24) og smerteintensitet (f.eks. NRS, BPI) på tværs af grupperne for at evaluere effektiviteten. Sekundære resultater inkluderer smerteopfattelse, kvantitativ sensorisk test, fMRI, MEG, metaboliske markører, neurotransmitter- og inflammationsbiomarkører. Dette studie har til formål at give en præcis, individuel terapeutisk strategi, reducere afhængigheden af farmakoterapi og fremme udviklingen af indenlandske højteknologiske medicinske apparater.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

160

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
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200072
        • Rekruttering
        • Shanghai Tenth People's Hospital
        • Kontakt:
      • Shanghai, Shanghai Municipality, Kina, 200030
        • Rekruttering
        • Shanghai Mental Health Center
        • Kontakt:
        • 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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Alder 18-65 år;
  2. Opfyld diagnostiske kriterier for en depressiv episode i henhold til ICD-11 med aktuelle lette til moderate depressive symptomer (HAMD-24 score ≥8 og ≤34);
  3. Rapporter vedvarende smerter, der har varet ≥3 måneder, og score ≥4 på punkt 5 i Brief Pain Inventory (BPI);
  4. Oprethold en stabil antidepressiv medicin- og psykologisk behandlingsplan (inklusive dosis, lægemiddeltype eller terapeutisk tilgang) i mindst fire uger før inddelingen;
  5. Højrehåndet med normalt hørelse, syn eller korrigeret syn;
  6. I stand til frivilligt at give skriftligt informeret samtykke til at deltage i studiet og villig og i stand til at overholde alle studiemetoder.

Eksklusionskriterier:

  1. Diagnosticeret med andre psykiatriske lidelser, inklusive skizofrenispektrumforstyrrelser, bipolar I-forstyrrelse (grundet potentiel risiko for maniske episoder og kontraindikation for lithium eller antikonvulsiva), primære angstforstyrrelser, depression forbundet med alvorlig somatisk sygdom osv.
  2. Aktivt selvmordstanker, defineret som en score på 4 på punkt 3 i HAMD-24.
  3. Alvorlig eller behandlingsresistent depression (HAMD-24 score ≥35, med nuværende depressiv episode, der har varet mindst 2 år eller manglende respons på to eller flere antidepressive behandlinger under den aktuelle episode).
  4. Stofmisbrugsforstyrrelse inden for de sidste 3 måneder.
  5. Oplevelse af ondartet smerte på grund af kræftsmerte syndrom, viscerale smerter (f.eks. mavesmerter) eller henviste smerter (f.eks. rygpine fra bugspytkirtelbetændelse).
  6. Neurologiske lidelser forbundet med strukturelle hjernændringer (f.eks. traumatisk hjerneskade, nyligt slagtilfælde, hjernetumor).
  7. Har gennemgået neuromodulationsbehandlinger inden for de sidste 3 måneder, inklusive elektrokonvulsiv terapi (MECT), repetitiv transkraniel magnetisk stimulation (rTMS) eller transkraniel elektrisk stimulation (tES).
  8. Kontraindikationer for transkraniel elektrisk stimulation (f.eks. intrakranielle metalimplantater, hjertestimulator, cochleaimplantat, hudlæsioner på stimulationssteder, personlig eller familiær historie med epilepsi).
  9. Nuværende eller inden for de sidste 1 måneds brug af medicin, der påvirker centralnervesystemets excitabilitet eller smerte, såsom antikonvulsiva, lithium, opioider, ikke-steroide antiinflammatoriske stoffer og antipsykotika. Lejlighedsvis brug efter behov af acetaminophen som redningsmedicin er tilladt, men skal dokumenteres i detaljer i studiedagbogen.
  10. Tegn på demens eller anden alvorlig kognitiv svækkelse (MoCA score <17).
  11. Alvorlige eller ustabile somatiske sygdomme, herunder men ikke begrænset til: neurologiske lidelser (f.eks. epilepsi, slagtilfælde, migræne, historie med kranieoperation); kardiovaskulære sygdomme (f.eks. ukontrolleret hypertension, hjertesvigt, arytmi, myocardieinfarkt); respiratoriske forstyrrelser (f.eks. alvorlig søvnapnø syndrom); malignitet eller immun kompromitteret status; ukontrolleret diabetes (fastende blodsukker >12 mmol/L).
  12. Graviditet eller amning.
  13. Samtidig deltagelse i et andet klinisk forsøg, deltagelse i et hvilket som helst klinisk forsøg inden for de sidste 90 dage eller planlagt deltagelse i et andet forsøg under studieperioden.
  14. Eventuelle kontraindikationer for magnetisk resonans scanning (f.eks. metalimplantater, klaustrofobi, respiratoriske eller motoriske handicaps).
  15. Manglende evne til at samarbejde med studieundersøgelserne.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: tDCS
Participants receive active tDCS. The anodal electrode is placed over the left dorsolateral prefrontal cortex (F3), and the cathodal electrode is placed over the right dorsolateral prefrontal cortex (F4). A constant current of 2 mA is applied for 40 minutes per session, with a 30-second ramp-up and ramp-down period. The intervention is administered once daily for 2 weeks (total of 10 sessions).
Enhed: tDCS
Participants receive active tDCS. The anodal electrode (5 × 5 cm) is placed over the left dorsolateral prefrontal cortex (F3), and the cathodal electrode (5 × 7 cm) is placed over the right dorsolateral prefrontal cortex (F4). A constant current of 2 mA is applied for 40 minutes per session, with a 30-second ramp-up and ramp-down period. The intervention is administered once daily for 2 weeks (total of 10 sessions).
Eksperimentel: alpha-tACS
Participants receive active alpha-tACS. Two electrodes are placed over F3 and F4. A sinusoidal alternating current at 10 Hz frequency (alpha band) is applied 1 mA (zero-to-peak) at the F3 and F4 electrodes. Stimulation duration is 40 minutes per session, including 30-second ramp-up and ramp-down periods. The intervention is administered once daily, 5 days per week, for 2 weeks (total of 10 sessions).
Enhed: alpha-tACS
Participants receive active alpha-tACS. Two electrodes are placed over F3 and F4. A sinusoidal alternating current at 10 Hz frequency (alpha band) is applied 1 mA (zero-to-peak) at the F3 and F4 electrodes. Stimulation duration is 40 minutes per session, including 30-second ramp-up and ramp-down periods. The intervention is administered once daily, 5 days per week, for 2 weeks (total of 10 sessions).
Sham-komparator: Sham
Sham group using the same electrode montage at F3/F4. To maintain blinding, the stimulator delivers current only during the initial 30-second ramp-up period, followed by an immediate ramp-down, and a final 30-second ramp-up at the end of the stimulation session. This mimics the initial sensation of active stimulation without delivering sufficient current to induce neural modulation.
Enhed: Sham
Sham group using the same electrode montage at F3/F4. To maintain blinding, the stimulator delivers current only during the initial 30-second ramp-up period, followed by an immediate ramp-down, and a final 30-second ramp-up at the end of the stimulation session. This mimics the initial sensation of active stimulation without delivering sufficient current to induce neural modulation.
Eksperimentel: Exploratory Open-Label tACS Group
Participants in this exploratory arm receive the same active tACS intervention as Arm alpha-tACS, with identical stimulation parameters (e.g., 1 mA, 40 minutes, 10 Hz, targeting the bilateral dorsolateral prefrontal cortex (DLPFC)). This arm is open-label (unblinded): participants and study personnel are aware of the treatment assignment. It serves as a supplementary exploratory cohort to explore preliminary neural oscillation entrainment effects of tACS. Unlike Arms 1-3, this arm is neither randomized nor blinded. Data from this arm will be analyzed separately and are not included in the primary confirmatory hypothesis testing of the randomized controlled trial. The overall study remains double-blind for the three-arm RCT component, with this exploratory arm conducted as an ancillary cohort.
Enhed: alpha-tACS
Participants receive active alpha-tACS. Two electrodes are placed over F3 and F4. A sinusoidal alternating current at 10 Hz frequency (alpha band) is applied 1 mA (zero-to-peak) at the F3 and F4 electrodes. Stimulation duration is 40 minutes per session, including 30-second ramp-up and ramp-down periods. The intervention is administered once daily, 5 days per week, for 2 weeks (total of 10 sessions).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants Achieving MCID on BPI Pain Intensity Subscale
Tidsramme: At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline

Description:

The BPI is a validated self-administered questionnaire that assesses the severity of pain and its impact on daily functioning. The pain intensity subscale consists of four items rating pain at its "worst," "least," "average," and "current" (right now). Each item is rated on a 0 to 10 numeric rating scale. Higher scores mean a worse outcome.

The Minimal Clinically Important Difference (MCID) is defined as a reduction of ≥ 1 point from baseline in the BPI pain intensity score. The outcome is the proportion of participants in each group who achieve this MCID threshold at each follow-up time point.
At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage Reduction from Baseline in HAMD-17 Total Score
Tidsramme: At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline

The HAMD-17 is a 17-item clinician-rated scale assessing depression severity. Items are rated on 3- or 5-point scales, with total scores ranging from 0 to 52. Higher scores mean a worse outcome (greater depression severity).

The outcome is the percentage reduction in HAMD-17 total score from baseline at each follow-up time point, calculated using the formula:

[(Baseline score - Follow-up score) / Baseline score] × 100%

A positive percentage indicates improvement (reduction in depressive symptoms).
At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Change from Baseline in HAMD-17 Total Score
Tidsramme: At 1 week (mid-intervention), 2 weeks (post-intervention), and 6 weeks (follow-up)
The Hamilton Depression Rating Scale (HAMD-17) is a 17-item clinician-rated scale assessing depression severity. Items are rated on 3- or 5-point scales, with total scores ranging from 0 to 52. Higher scores indicate greater depression severity (worse outcome). The outcome is the absolute change in the total score from baseline at each follow-up time point, calculated as: [(Baseline score) - (Follow-up score)]. A positive change value indicates improvement (reduction in depressive symptoms). No pre-defined clinically meaningful threshold is applied to this continuous outcome; it is reported as the mean absolute change per group.
At 1 week (mid-intervention), 2 weeks (post-intervention), and 6 weeks (follow-up)
Change from Baseline in Pain Catastrophizing Scale (PCS) Total Score
Tidsramme: At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
The Pain Catastrophizing Scale (PCS) is a 13-item self-reported questionnaire. Each item is rated on a 5-point Likert scale from 0 (not at all) to 4 (all the time), with total scores ranging from 0 to 52. Higher scores indicate higher levels of pain catastrophizing (worse outcome). The outcome is the absolute change in the total score from baseline at each follow-up time point, calculated as: [(Baseline score) - (Follow-up score)]. A positive change value indicates improvement (reduction in pain catastrophizing).
At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Change from Baseline in Generalized Anxiety Disorder Scale-7 (GAD-7) Total Score
Tidsramme: At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
The GAD-7 is a 7-item self-report scale (0-21, higher scores = worse outcome) assessing anxiety symptoms over the past two weeks. The outcome is the absolute change in the total score from baseline at each follow-up time point, calculated as: [(Baseline score) - (Follow-up score)].
At 1 week (mid-intervention), 2 weeks (end of intervention), and 6 weeks (follow-up) post-baseline
Change from Baseline in Clinical Global Impression (CGI) Total Score
Tidsramme: At 1 week (mid-intervention), 2 weeks (post-intervention), and 6 weeks (follow-up)

The Clinical Global Impression (CGI) scale consists of two clinician-rated subscales assessing overall treatment response:

CGI-Severity (CGI-S): Rates the severity of the patient's illness on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores mean a worse outcome.

CGI-Improvement (CGI-I): Rates the patient's improvement compared to baseline on a 7-point scale from 1 (very much improved) to 7 (very much worse). This subscale is only assessed at post-baseline time points. Lower scores mean a better outcome (greater improvement).

The outcome is the change from baseline in CGI-S score at each follow-up time point, and the CGI-I score at each post-baseline time point.
At 1 week (mid-intervention), 2 weeks (post-intervention), and 6 weeks (follow-up)
Change from Baseline in Resting-State Functional Connectivity of the DLPFC at 2 Weeks
Tidsramme: Baseline and immediately after the 2-week intervention period
Resting-state functional connectivity (rs-FC) of the dorsolateral prefrontal cortex (DLPFC) is assessed using resting-state functional magnetic resonance imaging (rs-fMRI). The primary measurement is the change in seed-based functional connectivity strength between the DLPFC and its target network regions (e.g., parietal cortex, default mode network nodes), quantified as Fisher-transformed correlation coefficients (z-values) from a priori defined regions of interest. Higher z-values indicate stronger positive functional connectivity; lower or negative values indicate weaker or anticorrelated connectivity. Structural MRI (sMRI) is acquired for co-registration and normalization purposes.
Baseline and immediately after the 2-week intervention period

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Brain-Derived Exosome Metabolite Levels
Tidsramme: From baseline to post-intervention at 2 weeks
Metabolite profiles are measured using untargeted liquid chromatography-mass spectrometry (LC-MS) in plasma-derived brain-enriched exosomes. Changes in metabolite profiles from baseline to post-intervention are assessed using multivariate partial least squares discriminant analysis (PLS-DA). The primary comparison is the separation distance (e.g., Q² or R² values) between baseline and post-intervention clusters, with positive values indicating greater separation between the two time points. This is an exploratory outcome to identify potential metabolic biomarkers and generate hypotheses related to the mechanisms of tACS/tDCS action. Results will be reported descriptively and are not part of the primary confirmatory analysis.
From baseline to post-intervention at 2 weeks
Change from Baseline in BPI Pain Intensity Score in the Exploratory Open-Label Cohort
Tidsramme: From baseline to post-intervention at 2 weeks
This exploratory outcome measures the change from baseline in the BPI Pain Intensity score after 10 sessions of active tACS in the open-label arm. Data are reported descriptively as individual change values, mean change, standard deviation, and within-group effect size (Cohen's d) . No formal hypothesis testing is planned; the results will inform effect size estimation for future trial planning.
From baseline to post-intervention at 2 weeks
Change from Baseline in HAMD-17 Total Score in the Exploratory Open-Label Cohort
Tidsramme: From baseline to post-intervention at 2 weeks
This exploratory outcome measures the change from baseline in HAMD-17 total score after 10 sessions of active tACS in the open-label arm. Data are reported descriptively as individual change values, mean change, standard deviation, and within-group effect size (Cohen's d). No formal hypothesis testing is planned; the results will inform effect size estimation for future trial planning.
From baseline to post-intervention at 2 weeks
Change from Baseline in GAD-7 Total Score in the Exploratory Open-Label Cohort
Tidsramme: From baseline to post-intervention at 2 weeks
This exploratory outcome measures the change from baseline in GAD-7 total score after 10 sessions of active tACS in the open-label arm. Data are reported descriptively as individual change values, mean change, standard deviation, and within-group effect size (Cohen's d). No formal hypothesis testing is planned. GAD-7 scores will also be explored as a covariate in pain outcome analyses.
From baseline to post-intervention at 2 weeks
Change from Baseline in Resting-State EEG Power Spectra in the Exploratory Open-Label Cohort
Tidsramme: Baseline, Day 1 (immediately before and after the 1st tACS session), Day 10 (immediately before and after the 10th tACS session), and Day 11 (on the day after completion of all 10 sessions)
Resting-state EEG is recorded for 5 minutes with eyes open and 5 minutes with eyes closed using a 64-channel EEG system. The primary measure is the change from baseline in spectral power (absolute and relative) across frequency bands (delta: 1-4 Hz, theta: 4-8 Hz, alpha: 8-12 Hz, beta: 12-30 Hz, gamma: 30-50 Hz), with a focus on the alpha band (8-12 Hz) due to the 10 Hz tACS intervention. Data are analyzed descriptively without formal hypothesis testing.
Baseline, Day 1 (immediately before and after the 1st tACS session), Day 10 (immediately before and after the 10th tACS session), and Day 11 (on the day after completion of all 10 sessions)
Change from Baseline in Task-State EEG (Event-Related Potentials) in the Exploratory Open-Label Cohort
Tidsramme: Baseline and Day 11 (on the day after completion of all 10 tACS sessions)
Task-state EEG is recorded while participants perform a cognitive task (e.g., working memory or attention task). The primary measure is the change from baseline in event-related potential (ERP) components and task-related spectral power changes (event-related desynchronization/synchronization). Data are analyzed descriptively without formal hypothesis testing.
Baseline and Day 11 (on the day after completion of all 10 tACS sessions)
Change from Baseline in Resting-State EEG Functional Connectivity in the Exploratory Open-Label Cohort
Tidsramme: Baseline and Day 11 (on the day after completion of all 10 sessions)
Resting-state EEG functional connectivity is assessed using coherence and phase-locking value (PLV) between electrode pairs, with a focus on the alpha band and the DLPFC region. Data are analyzed descriptively without formal hypothesis testing.
Baseline and Day 11 (on the day after completion of all 10 sessions)

Samarbejdspartnere og efterforskere

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

Sponsor

Shanghai Mental Health Center

Samarbejdspartnere

Shanghai 10th People's Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine

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 (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. februar 2028

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

3. januar 2026

Først indsendt, der opfyldte QC-kriterier

3. januar 2026

Først opslået (Faktiske)

12. januar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2026

Sidst verificeret

1. december 2025

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-80

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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