Precision Closed-loop Brain-Computer Interface Neuromodulation for Treatment-Resistant Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Mental Health Center
About this trial
The goal of this clinical trial is to evaluate whether precision closed-loop neuromodulation treatments can improve depressive symptoms and daily functioning in people with treatment-resistant major depressive disorder (TRD). The study will assess the effectiveness and safety of two neuromodulation approaches: closed-loop deep brain stimulation (DBS) and transcutaneous auricular vagus nerve stimulation (taVNS).
Treatment-resistant major depressive disorder refers to depression that does not improve sufficiently after adequate treatment with standard antidepressant therapies. This study focuses on people with TRD, including individuals with early-onset depression, a history of self-harm or suicidal thoughts, or depression associated with traumatic experiences.
This study aims to answer whether closed-loop DBS and taVNS can reduce depressive symptoms compared with sham stimulation, whether these treatments are safe and well tolerated, and whether changes in brain activity are associated with clinical improvement.
This is a multicenter, prospective clinical study conducted at Shanghai Mental Health Center, Beijing Anding Hospital, and Xuanwu Hospital. Eligible participants with TRD will receive either DBS or taVNS according to patient preference. Within each intervention group, participants will be randomly assigned to active stimulation or sham stimulation groups to assess treatment effects.
During the study, participants will receive neuromodulation treatment and complete regular follow-up assessments. These assessments will include evaluation of depressive symptoms, anxiety symptoms, cognitive function, social functioning, brain electrical activity using electroencephalography (EEG), brain imaging using magnetic resonance imaging (MRI), and monitoring of adverse events.
The study will compare changes in clinical symptoms, brain-related measures, and safety outcomes between active and sham stimulation groups. The findings may help determine whether precision neuromodulation approaches can provide a new treatment option for people with treatment-resistant major depressive disorder.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 70 years, regardless of sex.
At least primary school education and able to understand the content of the assessment scales.
Meet the diagnostic criteria for depressive disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Have a history of depression lasting at least 24 months and have received adequate-dose and adequate-duration treatment with at least 2 antidepressants for 8 weeks or longer, including electroconvulsive therapy without anesthesia, with a reduction rate in the HAMD-17 score of 20% or less after treatment.
Disqualifiers
Previous diagnosis of: schizophrenia; schizoaffective disorder; substance dependence or drug addiction; mental disorders secondary to other medical conditions; or presence of significant psychotic symptoms, including delusions and hallucinations.
Presence of severe or unstable disorders involving the: central nervous system; cardiovascular system; respiratory system; liver; kidney; endocrine system; hematological system; or other major organ systems, which, in the investigator's judgment, make the participant unsuitable for enrollment.
Female participants who are: pregnant; breastfeeding; planning pregnancy during the study period or within 8 weeks after the last medication administration; or male participants with plans for reproduction during the study period.
Participation in another clinical trial within the previous 3 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Closed-loop Deep Brain Stimulation (DBS)
DeviceClosed-loop deep brain stimulation (DBS) is an implanted neuromodulation intervention that delivers electrical stimulation based on real-time neural signals. Participants assigned to the DBS pathway will undergo implantation of a DBS system and receive either active or delayed stimulation according to the randomized study assignment. Clinical outcomes, cognitive function, brain activity, and safety outcomes will be assessed during follow-up.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
DeviceTranscutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation intervention that delivers electrical stimulation through electrodes placed on auricular sites associated with the vagus nerve. Participants assigned to the taVNS pathway will receive either active or sham stimulation according to the randomized study assignment. Clinical outcomes, cognitive function, brain activity, and safety outcomes will be assessed during follow-up.
Treatment groups
70 Participants
are divided into 4 treatment groupsGroup A: Active DBSExperimental treatment 1 intervention
Group B: Sham DBSham comparator 1 intervention
Group C: Active taVNSExperimental treatment 1 intervention
Group D: Sham taVNSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in 17-item Hamilton Rating Scale for Depression (HAMD-17) score
The primary efficacy outcome is the change in the 17-item Hamilton Depression Rating Scale (HAMD-17) score from baseline to week 8 after intervention. The HAMD-17 is used to assess the severity of depressive symptoms, with higher scores indicating greater severity of depressive symptoms. A decrease in HAMD-17 score indicates improvement in depressive symptoms.
Time frame
Baseline to Week 8Secondary outcomes
1
Change in Hamilton Anxiety Rating Scale (HAMA) score
The change in Hamilton Anxiety Rating Scale (HAMA) score from baseline to Week 8 will be evaluated to assess changes in anxiety symptom severity. The HAMA total score ranges from 0 to 56, with higher scores indicating greater severity of anxiety symptoms. A decrease in HAMA score indicates improvement in anxiety symptoms.
Time frame
Baseline to Week 82
Change in Montreal Cognitive Assessment scale (MoCA) score
The change in Montreal Cognitive Assessment (MoCA) score from baseline to Week 8 will be evaluated to assess changes in cognitive function. The MoCA total score ranges from 0 to 30, with higher scores indicating better cognitive function. An increase in MoCA score indicates improvement in cognitive function.
Time frame
Baseline to Week 83
Change in Montgomery-Asberg Depression Rating Scale (MADRS) score
The change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to Week 8 will be evaluated to assess changes in depressive symptom severity. The MADRS total score ranges from 0 to 60, with higher scores indicating greater severity of depressive symptoms. A decrease in MADRS score indicates improvement in depressive symptoms.
Time frame
Baseline to Week 84
Change in Patient Health Questionnaire-9 (PHQ-9) score
The change in Patient Health Questionnaire-9 (PHQ-9) score from baseline to Week 8 will be evaluated to assess changes in depressive symptoms. The PHQ-9 total score ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms. A decrease in PHQ-9 score indicates improvement in depressive symptoms.
Time frame
Baseline to Week 8Locations
Sponsors and contacts
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Shanghai Mental Health Center
Lead sponsor
Xuanwu Hospital, Beijing
Collaborator
Anding Hospital, Beijing
Collaborator
Source ClinicalTrials.gov
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