Effects of Concurrent and Consecutive Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Bias Modification (CBM) (TMS CBM)
4. juni 2026 oppdatert av: Richard Liu, The University of Hong Kong
The goal of this study is to learn whether combining repetitive transcranial magnetic stimulation (rTMS) with a computerized behavioral intervention (imagery cognitive bias modification, CBM-I) reduces negative interpretation bias and mild-to-moderate depressive symptoms. The study will also examine neural changes in the dorsolateral prefrontal cortex (DLPFC) and whether timing of interventions affects outcomes.
The main questions it aims to answer are:
Does active TMS reduce negative interpretation bias and depressive symptoms more than sham TMS? Is delivering CBM-I concurrently with TMS more effective than delivering it consecutively (separate sessions) at reducing negative bias and depressive symptoms? Do combined rTMS + CBM-I approaches produce greater neural changes and improved cognitive control over self-referential interpretation than controls? Researchers will compare active TMS versus sham TMS, and concurrent versus consecutive delivery of CBM-I, to test effects on negative bias and depressive symptoms.
Participants will:
Receive either active rTMS or sham TMS targeting the DLPFC Complete imagery CBM-I sessions either concurrently with TMS or in separate (consecutive) sessions Undergo assessments of negative interpretation bias, depressive symptoms, and neural measures before and after the intervention
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
180
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: Richard Liu Mr. Liu
- Telefonnummer: +85290971398
- E-post: richliu18@connect.hku.hk
Studiesteder
-
-
Hong Kong Island
-
Quarry Bay, Hong Kong Island, Hong Kong
- Rekruttering
- InnoCentre of Clinical Neuropsychology, The University of Hong Kong
-
Ta kontakt med:
- Richard Mr. Liu
- Telefonnummer: +85290971398
- E-post: richliu18@connect.hku.hk
-
-
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
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Aged 18 years or above
- Right-handed
- Normal or corrected hearing and vision
- Obtained primary education or above
- Able to fluently read and understand Chinese
- Beck's Depression Inventory-II (BDI-II) score ranging from 14-28
Exclusion Criteria:
- History of severe physical disease, brain organic diseases, and neurological disorders (e.g., dementia, brain injury, stroke, epilepsy, Parkinson's disease)
- History of substance use/ dependence/ withdrawal
- Participants with intellectual disability based on IQ scores
- Participants with contraindications for rTMS such as foreign metal bodies, implant devices (cochlear implants) or history (personal or family) of seizure
- Participants who are not suitable to be scanned by magnetic resonance imaging (MRI) machine (e.g., claustrophobic, pregnant, metal in the body, hearing aids)
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: Faktoriell oppgave
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: CC-R-CBM
Concurrent, Real TMS, CBM
|
The rTMS group will receive 10 Hz stimulation to the left DLPFC at an intensity of 120% of the resting motor threshold of the right abductor pollicis brevis (APB) muscle with 4 sec trains and 11 sec intertrain intervals for 3000 pulses.Specifically in our study, we combine both intervention, but applying them concurrently and consecutively between groups.
Imagery CBM-I focuses on 2 cognitive aspects, mental imagery and interpretation.
Participants will be presented with scenarios in which they have to imagine themselves to be in and practice constructing positive endings or interpretations for them.
|
|
Sham-komparator: CC-S-CBM
Concurrent, Sham TMS, CBM
|
Imagery CBM-I focuses on 2 cognitive aspects, mental imagery and interpretation.
Participants will be presented with scenarios in which they have to imagine themselves to be in and practice constructing positive endings or interpretations for them.
The TMS coil will be rotated 90 degrees, and will not be delivering active stimulation to the participant.
The intensity will be set to 30 and the TMS device will be active, generating enough sound effect but no real stimulation for sham control.
|
|
Aktiv komparator: CS-R-CBM
Consecutive, Real TMS, CBM
|
The rTMS group will receive 10 Hz stimulation to the left DLPFC at an intensity of 120% of the resting motor threshold of the right abductor pollicis brevis (APB) muscle with 4 sec trains and 11 sec intertrain intervals for 3000 pulses.Specifically in our study, we combine both intervention, but applying them concurrently and consecutively between groups.
Imagery CBM-I focuses on 2 cognitive aspects, mental imagery and interpretation.
Participants will be presented with scenarios in which they have to imagine themselves to be in and practice constructing positive endings or interpretations for them.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cognitive Bias
Tidsramme: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Self-Referent Encoding Task Tool: PsychoPy Unit:Self-Referential Bias Index measured by positive and negative self-description affirmation
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Depressive Symptoms
Tidsramme: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Beck's Depressive Inventory-II Tool: Qualtrics Questionnaire Unit:Beck's Depressive Inventory-II Index
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Resting State functional MRI
Tidsramme: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: resting-state functional MRI Image Tool: SIGNA Premier 3T wide-bore MRI scanner Unit: functional dicom images
|
"From enrollment to the end of treatment at 4 weeks"
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective Well Being
Tidsramme: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Subjective Well-Being Scale Tool: Qualtrics Questionnaire Unit: Subjective Well-Being Index
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Sleep Quality
Tidsramme: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Pittsburgh Sleep Quality Index (PSQI) Tool: Qualtrics Questionnaire Unit: Sleep Quality Index
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Anxiety Symptoms
Tidsramme: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Beck Anxiety Inventory Task Tool: Qualtrics Questionnaire Unit: Anxiety Index
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Structural MRI
Tidsramme: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: T1 Structural MRI Brain Image Tool: SIGNA Premier 3T wide-bore MRI scanner Unit: structural dicom images
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Rumination Symptoms
Tidsramme: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Rumination Response Scale (RRS) Task Tool: Qualtrics Questionnaire Unit: Rumination Index
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Anhedonia Symptoms
Tidsramme: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Dimensional Anhedonia Rating Scale Tool: Qualtrics Questionnaire Unit: Anhedonia Index
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Cognitive Measures-Attention
Tidsramme: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Conners Continuous Performance Tests - III Tool: CPT-III (Computer Task) Unit: Reaction Time
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Cognitive Measures-Attention
Tidsramme: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Conners Continuous Performance Tests - III Tool: CPT-III (Computer Task) Unit: Correct Responses and Error responses will be used to calculate a performance index of sustained attention
|
"From enrollment to the end of treatment at 4 weeks"
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
24. februar 2025
Primær fullføring (Antatt)
1. desember 2028
Studiet fullført (Antatt)
1. desember 2028
Datoer for studieregistrering
Først innsendt
28. april 2026
Først innsendt som oppfylte QC-kriteriene
4. juni 2026
Først lagt ut (Faktiske)
9. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- EA230645
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .