Treatment-resistant depression, chronic insomnia disorder
Conditions
Interventions
TRD active TI stimulation group:Participants receive active transcranial temporal interference stimulation targeting the bilateral subcallosal cingulate cortex. The intervention is delivered for 7 con
TRD control stimulation group:Participants receive control stimulation with the same appearance and procedure as the active stimulation condition but without real electrical stimulation output. The in
Chronic insomnia active TI stimulation group:Participants receive active transcranial temporal interference stimulation targeting the bilateral subcallosal cingulate cortex. The intervention is delive
Chronic insomnia control stimulation group:Participants receive control stimulation with the same appearance and procedure as the active stimulation condition but without real electrical stimulation o
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: This study includes two study cohorts: Cohort 1, the treatment-resistant depression (TRD) cohort, and Cohort 2, the chronic insomnia cohort. The inclusion criteria for each cohort are as follows: Cohort 1: TRD Cohort (Treatment-Resistant Depression) (1) Aged between 18 and 65 years. (2) Having a junior high school education or above, with basic comprehension and cooperation abilities, and able to understand the study purpose and complete the relevant assessments and intervention procedures. (3) Meeting the diagnostic criteria for major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and meeting the diagnostic criteria for TRD: poor response after at least two antidepressant treatments of adequate dose and duration, with a 17-item Hamilton Depression Rating Scale (HAMD-17) score >=17. (4) Having a stable medication regimen for >=4 weeks before the study (stable medication type and dosage), and agreeing not to initiate or adjust medication treatment during the study intervention period, except when medically necessary. (5) Disease course requirement: the current depressive episode has lasted for =8 weeks. (6) Providing signed informed consent. Cohort 2: Chronic Insomnia Cohort (1) Aged 18–65 years. (2) Meeting the diagnostic criteria for chronic insomnia disorder according to the International Classification of Sleep Disorders, Third Edition (ICSD-3): insomnia symptoms lasting for >=3 months, with any of the following symptoms occurring on =3 nights per week: difficulty initiating sleep, difficulty maintaining sleep, or early morning awakening, accompanied by daytime functional impairment. Sleep disturbance severity will be defined by a Pittsburgh Sleep Quality Index (PSQI) total score >7 as the enrollment threshold. (3) Having a stable regimen of sleep-aid or psychiatric-related medications for >=4 weeks before enrollment (unchanged medication type and dosage), and agreeing in principle not to adjust medication during the intervention period unless medically necessary. (4) Providing signed informed consent.
Exclusion criteria
Exclusion criteria: This study includes two study cohorts: Cohort 1, the treatment-resistant depression (TRD) cohort, and Cohort 2, the chronic insomnia cohort. The exclusion criteria for each cohort are as follows: Cohort 1: TRD Cohort (Treatment-Resistant Depression) (1) Participants with other major psychiatric disorders, such as psychoactive substance use disorder, schizophrenia, bipolar disorder, or those with obvious high suicide risk requiring emergency intervention, will not be included. Participants with non-primary clinical problems such as anxiety disorders or obsessive-compulsive disorder may be considered for inclusion if their condition is stable. (2) Participants with implanted devices or metallic objects that may interfere with the safety of neuromodulation, such as metallic implants in the head or head-and-neck region, including aneurysm clips, metal plates, metal nails, deep brain stimulation electrodes, or implanted cardiac pacemakers, defibrillators, or other active electronic medical devices. (3) Participants with a history of major neurological diseases that may affect electroencephalographic activity or neurological function, such as epilepsy, cerebrovascular accidents, including cerebral infarction or cerebral hemorrhage, severe traumatic brain injury, or craniocerebral surgery; or those with obvious skull defects or sequelae of traumatic brain injury. (4) Participants with severe physical diseases, such as coronary heart disease, severe arrhythmia, chronic obstructive pulmonary disease, or severe hepatic or renal dysfunction, that may interfere with the safety of the intervention or the interpretation of study results. (5) Women who are pregnant, breastfeeding, or planning to become pregnant in the near future, because the safety of TI stimulation has not yet been established in this population. (6) Participants who have received other forms of electrical stimulation therapy within the past 3 months. Cohort 2: Chronic Insomnia Cohort (1) Current major depressive episode or treatment-resistant depression (TRD): participants who meet the DSM-5 criteria for a current major depressive episode, or who meet the definition of treatment-resistant depression (TRD), will be excluded; participants with obvious depressive symptoms will also be excluded (HAMD-17 score >7). (2) Other primary sleep disorders: participants whose main condition is moderate-to-severe obstructive sleep apnea, restless legs syndrome/periodic limb movement disorder, narcolepsy, REM sleep behavior disorder, or circadian rhythm sleep-wake disorder. (3) Severe psychiatric disorders, psychotic states, or high-risk psychiatric conditions: participants with bipolar disorder, schizophrenia spectrum disorders, or current psychotic symptoms; those with current substance use disorder or alcohol use disorder; and those with obvious high suicide risk or who are assessed as requiring emergency intervention. Mild anxiety symptoms are allowed, but current primary anxiety disorders or severe anxiety states will be excluded. (4) Neurological disease or epilepsy risk: history of epilepsy or unexplained seizures; intracranial space-occupying lesions; severe sequelae of traumatic brain injury; and other similar conditions. (5) Contraindications related to implants or electronic devices: intracranial metallic implants, cardiac pacemakers, implantable cardioverter-defibrillators (ICDs), and other similar devices. (6) Pregnancy and breastfeeding: pregnancy, breastfeeding, or planning to beco
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HAMD-17 score (TRD cohort);Change in PSQI score (chronic insomnia cohort); | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery–?sberg Depression Rating Scale (MADRS) score;Hamilton Anxiety Rating Scale (HAMA) score;Insomnia Severity Index (ISI) score;Patient Health Questionnaire-15 (PHQ-15) score;Fatigue Scale-14 (FS-14) score;Snaith-Hamilton Pleasure Scale (SHAPS) score;Ruminative Responses Scale (RRS) score;State-Trait Anxiety Inventory (STAI) score;Perceived Stress Scale (PSS) score;Social Disability Screening Schedule (SDSS) score;Electroencephalographic indicators;Event-related potential indicators;Polysomnography indicators (chronic insomnia cohort); | — |
Countries
China
Contacts
Public ContactYuan Yang
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed