Effects of Concurrent and Consecutive Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Bias Modification (CBM) (TMS CBM)
4 juni 2026 bijgewerkt door: 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
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
180
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Richard Liu Mr. Liu
- Telefoonnummer: +85290971398
- E-mail: richliu18@connect.hku.hk
Studie Locaties
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Hong Kong Island
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Quarry Bay, Hong Kong Island, Hongkong
- Werving
- InnoCentre of Clinical Neuropsychology, The University of Hong Kong
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Contact:
- Richard Mr. Liu
- Telefoonnummer: +85290971398
- E-mail: richliu18@connect.hku.hk
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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.
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Sham-vergelijker: 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.
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Actieve vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cognitive Bias
Tijdsspanne: "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
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"From enrollment to the end of treatment at 4 weeks"
|
|
Depressive Symptoms
Tijdsspanne: "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"
|
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Resting State functional MRI
Tijdsspanne: "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
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"From enrollment to the end of treatment at 4 weeks"
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Subjective Well Being
Tijdsspanne: "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"
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Sleep Quality
Tijdsspanne: "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
Tijdsspanne: "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
Tijdsspanne: "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"
|
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Rumination Symptoms
Tijdsspanne: "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"
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Anhedonia Symptoms
Tijdsspanne: "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"
|
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Cognitive Measures-Attention
Tijdsspanne: "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"
|
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Cognitive Measures-Attention
Tijdsspanne: "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"
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
24 februari 2025
Primaire voltooiing (Geschat)
1 december 2028
Studie voltooiing (Geschat)
1 december 2028
Studieregistratiedata
Eerst ingediend
28 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
4 juni 2026
Eerst geplaatst (Werkelijk)
9 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
4 juni 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- EA230645
Plan Individuele Deelnemersgegevens (IPD)
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ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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