Effects of Concurrent and Consecutive Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Bias Modification (CBM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TMS, Cognitive Bias Modification, Sham TMS.
- Who it may be relevant to
- Registry conditions: Depression - Major Depressive Disorder. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Device TMS
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. - Behavioral Cognitive Bias Modification
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. - Device Sham TMS
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.
Primary outcome measures
- Cognitive Bias [Time frame: "From enrollment to the end of treatment at 4 weeks"]
- Depressive Symptoms [Time frame: "From enrollment to the end of treatment at 4 weeks"]
- Resting State functional MRI [Time frame: "From enrollment to the end of treatment at 4 weeks"]
Secondary outcome measures (8)
- Subjective Well Being [Time frame: "From enrollment to the end of treatment at 4 weeks"]
- Sleep Quality [Time frame: "From enrollment to the end of treatment at 4 weeks"]
- Anxiety Symptoms [Time frame: "From enrollment to the end of treatment at 4 weeks"]
- Structural MRI [Time frame: "From enrollment to the end of treatment at 4 weeks"]
- Rumination Symptoms [Time frame: "From enrollment to the end of treatment at 4 weeks"]
- Anhedonia Symptoms [Time frame: "From enrollment to the end of treatment at 4 weeks"]
- Cognitive Measures-Attention [Time frame: "From enrollment to the end of treatment at 4 weeks"]
- Cognitive Measures-Attention [Time frame: "From enrollment to the end of treatment at 4 weeks"]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- InnoCentre of Clinical Neuropsychology, The University of Hong Kong — Quarry Bay
Identifiers
NCT: NCT07636694 · EA230645