Neuromodulation and Attention Deficits in MDD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of Electronic Science and Technology of China
About this trial
Multimodal study (Behavior, TMS, EEG) combining a sham-controlled intermittent theta burst stimulation (iTBS) intervention with an additional-singleton task and EEG to evaluate whether left dorsolateral prefrontal cortex (DLPFC) stimulation enhances cognitive control and modulates maladaptive attention processes in MDD and whether the effects are influenced by neuronavigated versus manual (Beam F3 method) localization of the stimulation site.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-55 years
Right-handed
Normal or corrected normal visual acuity
MDD: meet the proposed DSM-5 MDD criteria, unmedicated or stable medicated within the last one month. Healthy subjects without any past or present psychiatric or neurological disorders.
Disqualifiers
Diagnosis of other severe mental disorders, such as schizophrenia, bipolar disorder, neurodevelopmental disorder, etc.
high suicidal risk
Unnormal intellectual functioning, auditory impairments,
Have received neuromodulation, such as Modified Electroconvulsive Therapy (MECT), or any psychotherapy within the past 6 months.
Trial design
Design model
Parallel
Treatments tested in this trial
intermittent theta burst stimulation (iTBS) intervention
DeviceiTBS protocol: Intervention with an 80-120% resting threshold was used. In the active group, the left dlPFC was selected as the stimulation site and a stimulation protocol with iTBS parameters was given. This was a neuro-modulation protocol of excitatory sequences, with theta burst stimulation at 50 Hz, repeated at 5 Hz, stimulation for 2 s with an interval of 8 s, for a total of 1,800 pulses, with a treatment time of about 20 min/session, two sessions per day, with a15-30 min rest between sessions, and five consecutive days of treatment per week, with a rest of 2 days, and two weeks of treatment.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: MDD subjects in the active group undergo 10 days of MRI-guided iTBS interventionExperimental treatment 1 intervention
Group B: MDD controls in the sham-iTBS group receive the same intervention but Beam F3 site.Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Depression severity following two weeks of iTBS treatment.
Depression severity will be assessed, using 24-item Hamilton Depression Scale (HAMD-24) before and after the iTBS intervention. Changes will be computed as (pre-treatment score - post-treatment score)/pre-treatment score × 100%). We hypothesize that the neuronaviogated group has a better treatment effect indexed by the mean HAMD subtraction rate than the sham-control group.
Time frame
60-90 minutes before the first iTBS treatment and 60-90 minutes after last iTBS treatment.Secondary outcomes
1
Intervention-related ERPs changes in the additional singleton task after 2 weeks of active/sham iTBS treatment.
Neuromodulation-induced iTBS changes will be measured by the probability cueing effects in the additional singleton task with ERP effects. N2pc and Pd components will be used to quantify attentional selection and distractor suppression. These ERP components reflect the neural mechanisms of spatial attention in MDD.
Time frame
30-60 minutes before the first iTBS treatment and 30-60 minutes after last iTBS treatment.2
Intervention-related brain connectivity after 2 weeks of active/sham iTBS treatment.
During the additional singleton task, we will measure network-level connectivity patterns between attention-related brain regions (e.g., fronto-parietal and sensory integration systems). Directed or undirected EEG connectivity methods (e.g., phase synchronization, Granger causality, or sPDC) will be applied to assess iTBS-induced changes in intrinsic attentional network architecture in MDD.
Time frame
30-60 minutes before the first iTBS treatment and 30-60 minutes after last iTBS treatment.3
Intervention-related behavior changes in the additional singleton task after 2 weeks of active/sham iTBS treatment.
Neuromodulation-induced iTBS changes will also be measured in RTs. We aim to examine whether the different RT effects in both groups occur between the pre-iTBS and post-iTBS conditions. For the between-group effect, compared to the sham-iTBS group, the active-iTBS group has faster RTs and statistical learning effects (e.g., subtraction RTs from the low-minus-high-probability distractor locations).
Time frame
30-60 minutes before the first iTBS treatment and 30-60 minutes after the last iTBS treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov