Deep Brain Stimulation (DBS): The DBS lead is stereotactically introduced into the target in the brain (SCC, VC/VS, ALIC, ITP, NAc, LHb, MFB, or other unreported nuclei targets) and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.
Study summary
The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) implantation in patients with Treatment-resistant Depression (TRD) targeting the ventral capsule/ventral striatum (VC/VS), Brodmann area 25/subcallosal cingulate (SCC), Anterior Limb of Internal Capsule (ALIC), inferior thalamic peduncle (ITP), nucleus accumbens (NAc), lateral habenula (LHb), medial forebrain bundle (MFB), or other unreported nuclei targets.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. male or female, 18-65 years old;
2. able to provide written informed consent voluntarily;
3. had a diagnosis of major depression disorder (MDD) (recurrent episodes) without psychotic features in compliance with the Diagnostic and Statistical Manual of Mental Disorders -Fourth Edition -Text Revised (DSM-IV-TR) and confirmed by the Mini-International Neuropsychiatric Interview Chinese version 5.0;
4. failure of response to at least two antidepressant medication trials based on the Massachusetts General Hospital antidepressant treatment response questionnaire (MGH-ATRQ);
5. ongoing antidepressant(s) at a fixed dose for at least four weeks before baseline assessment;
6. had a score of ≥201 on the Hamilton Depression Scale- item 17 (HAMD-17) at baseline.
Exclusion Criteria:
1. presence of other psychotic disorders;
2. have a treatment history that includes electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), DBS, and transcranial magnetic stimulation (TMS);
3. presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items);
4. experience difficulty in effectively communicating with investigators;
5. with a history of traumatic brain injury (TBI);
6. with intracranial or cardiovascular stents;
7. substance abuse within the past six months;
8. unstable neurological or coagulation disorders;
9. women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study;
10. have been involved in other clinical studies within three months before enrollment in this study;
11. any conditions considered by the study group.
Primary outcome measure(s)
The change from baseline to 12 months in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. — Baseline to 12 months post-surgery MADRS is an established instrument to rate symptoms of depression. The range of the total score is thus 0 to 60; higher total scores indicate more severe depressive symptoms.
Usual cutoff points are: 0 to 6: normal/symptom absent; 7 to 19: mild depression; 20 to 34: moderate depression; \>34: severe depression.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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