Early Identification of TRD and Construction and Clinical Validation of NTBS Precision Technology
NCT ID: NCT05777876
Last Updated: 2023-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2023-01-01
2025-12-31
Brief Summary
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it aims to answer are: • Construct a multimodal TRD early identification model based on clinical characteristics, blood factors, functional magnetic resonance and brain electrophysiological indicators; • Develop non-invasive transcranial deep brain stimulation technology based on focused electric field; • In TRD patients, an individualized non-invasive transcranial deep electrical stimulation technology based on precise magnetic resonance targets and EEG phase guidance was constructed.
Participants will:• be collected data multiple times including clinical symptoms, peripheral biology, functional magnetic resonance, electrophysiology and other clinical data before and after the intervention; • receive non-invasive transcranial deep brain stimulation or sham stimulation of different deep brain target points; • be collected EEG data while receiving stimulation.
Researchers will • compare the biological characteristics of TRD, n-TRD patients and health controls to build early identification models and find potential spatial and temporal intervention targets dependent on TRD status; • verify the safety of non-invasive transcranial deep brain stimulation device in health controls; • compare TRD with different modes of stimulation to find the best treatment plan for non-invasive transcranial deep brain stimulation and verify safety.
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Detailed Description
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Based on the previous research work, this project plans to establish a prospective cohort study of clinical cases, and to discover the clinical characteristics of TRD, factors carried by peripheral blood and exosomes (Hypocretin, Brain-derived neurotrophic fact, Reelin, N-methyl-D- Aspartic acid receptor), functional magnetic resonance and brain electrophysiological indicators and other objective biological markers, using multi-modal fusion to establish an early identification model for TRD. At the same time, we plan to analyze the abnormal brain network characteristics and abnormal EEG phase characteristics of TRD, in order to search for abnormalities through multi-dimensional data Potential spatial and temporal intervention targets dependent on TRD status.
Recently, a new non-invasive transcranial electrical stimulation method, namely Temporal Interference Stimulation (TIS), can non-invasively stimulate area-specific Focus on the deep brain area without affecting the upper brain area of the target area. This project will carry out the research and development of the principle prototype of the non-invasive transcranial deep electric Clinical curative effect comparison and safety evaluation, so as to verify the best TIS intervention target, on this basis, according to the above-explored TRD state-dependent EEG signals, through spontaneous synchronous oscillation signals between different channels on the neural loop , to achieve individualized neuromodulation. Finally, a diagnosis and treatment model for early identification of refractory depression and non-invasive transcranial deep electrical stimulation technology will be established to provide new guidance for TRD treatment.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
QUADRUPLE
Study Groups
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non-TRD
Patients with first episode or relapse of untreated depression group are treated with escitalopram for 8 weeks, and if effective, they are included in the n-TRD group. If ineffective, Venlafaxine is used for full treatment for 8 weeks; if effective, the patients are included in the non-TRD group. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring.
No interventions assigned to this group
TRD Target stimulation A
Patients do not respond favorably to two antidepressants. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. Regimen: Receiving TIS intervention with target A (Characteristic abnormal brain region targets based on data-driven exploration) for 10 times, once a day (except weekends and holidays) for 2 weeks. Stimulation（130Hz, 2mA total current intensity, each stimulation lasts for 30 minutes, 15 seconds respectively for import and exit).
non-invasive transcranial deep brain stimulation
A new non-invasive transcranial deep brain stimulation, Temporal Interference Stimulation (TIS), can focus the stimulation region specifically on the deep brain region without affecting the upper level of the target region. At present, the safety of this method has been preliminarily verified in animals and healthy people, but the brain target of TRD treatment is not clear.
TRD Target stimulation B
Patients do not respond favorably to two antidepressants. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. Regimen: Receiving TIS intervention with target B (Characteristic abnormal brain region targets based on data-driven exploration) for 10 times, once a day (except weekends and holidays) for 2 weeks. Stimulation（130Hz, 2mA total current intensity, each stimulation lasts for 30 minutes, 15 seconds respectively for import and exit).
non-invasive transcranial deep brain stimulation
A new non-invasive transcranial deep brain stimulation, Temporal Interference Stimulation (TIS), can focus the stimulation region specifically on the deep brain region without affecting the upper level of the target region. At present, the safety of this method has been preliminarily verified in animals and healthy people, but the brain target of TRD treatment is not clear.
TRD Target stimulation C
Patients do not respond favorably to two antidepressants. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. Regimen: Receiving TIS intervention with target C (Characteristic abnormal brain region targets based on data-driven exploration) for 10 times, once a day (except weekends and holidays) for 2 weeks. Stimulation（130Hz, 2mA total current intensity, each stimulation lasts for 30 minutes, 15 seconds respectively for import and exit).
non-invasive transcranial deep brain stimulation
A new non-invasive transcranial deep brain stimulation, Temporal Interference Stimulation (TIS), can focus the stimulation region specifically on the deep brain region without affecting the upper level of the target region. At present, the safety of this method has been preliminarily verified in animals and healthy people, but the brain target of TRD treatment is not clear.
TRD sham stimulation
Patients do not respond favorably to two antidepressants. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. Regimen: sham stimulation for 10 times, once a day (except weekends and holidays) for 2 weeks. Stimulation（130Hz, 2mA total current intensity, each stimulation lasts for 30 seconds, total wearing the instrument for 30 minutes)
Sham stimulation
Electrodes will be placed in the same location on the head as that for the TI intervention; 30 seconds of electrical current will be delivered to the brain (compared to 30 minutes in the experimental intervention arm), therefore it is expected to elicit no changes in neural activity.
TRD closed-loop stimulation
Patients do not respond favorably to two antidepressants. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. Patients receive closed-loop stimulation guided by EEG phase, and the stimulation target is the effective deep brain region target verified in this study. Regimen: stimulation for 10 times, once a day (except weekends and holidays) for 2 weeks. Stimulation（130Hz, 2mA total current intensity, each stimulation lasts for 30 minutes, 15 seconds respectively for import and exit)
non-invasive transcranial deep brain stimulation with closed-loop
Non-invasive transcranial deep brain stimulation devices based on closed-loop regulation of EEG can improve the accuracy of treatment.
HC experimental stimulation
The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. HC will receive TIS intervention in the exercise area for one time, the stimulation scheme adopted 20 Hz and 2mA total current intensity, and each stimulation lasted for 30 minutes (15 seconds respectively for lead-in and withdrawal)
Motor cortex stimulation
Receive stimulation in the motor cortex stimulation instead of deep brain.
HC sham stimulation
The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. Electrode placement, current intensity and intervention times are consistent with those of TIS regimen. 20 Hz, 2mA total current intensityis used, but only lasted for 30 seconds, and then the current is 0 for a total of 30 minutes.
Sham stimulation
Electrodes will be placed in the same location on the head as that for the TI intervention; 30 seconds of electrical current will be delivered to the brain (compared to 30 minutes in the experimental intervention arm), therefore it is expected to elicit no changes in neural activity.
HC observation
Collect data on healthy controls without stimulation. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring.
No interventions assigned to this group
Interventions
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non-invasive transcranial deep brain stimulation
A new non-invasive transcranial deep brain stimulation, Temporal Interference Stimulation (TIS), can focus the stimulation region specifically on the deep brain region without affecting the upper level of the target region. At present, the safety of this method has been preliminarily verified in animals and healthy people, but the brain target of TRD treatment is not clear.
Sham stimulation
Electrodes will be placed in the same location on the head as that for the TI intervention; 30 seconds of electrical current will be delivered to the brain (compared to 30 minutes in the experimental intervention arm), therefore it is expected to elicit no changes in neural activity.
Motor cortex stimulation
Receive stimulation in the motor cortex stimulation instead of deep brain.
non-invasive transcranial deep brain stimulation with closed-loop
Non-invasive transcranial deep brain stimulation devices based on closed-loop regulation of EEG can improve the accuracy of treatment.
Eligibility Criteria
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Inclusion Criteria
* 24 item Hamilton Depression Scale (HAMD-24)≥20;
* Age 18-60, gender unlimited;
* right hand;
* Han Chinese;
* Sign a written informed consent and be willing to participate in the study and be evaluated.
Exclusion Criteria
* Patients with metal objects in the body or other contraindications for MRI scanning;
* Suffering from a serious or unstable physical disease;
* Positive urine HCG test results of pregnant and lactating women and women of childbearing age during screening;
* Other conditions deemed unsuitable for participation in the clinical trial by the investigator.
18 Years
60 Years
ALL
Yes
Sponsors
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Zhejiang University
OTHER
Kangci Hospital of Jiaxing
UNKNOWN
Wenzhou Seventh People's Hospital
OTHER_GOV
Lishui Second People's Hospital
UNKNOWN
Huzhou Third People's Hospital
OTHER
Binjiang Institute of Zhejiang University
UNKNOWN
Zhejiang Newways Medical Technology Co., Ltd
UNKNOWN
Hangzhou Lingnao Technology Co., Ltd
UNKNOWN
First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Manli Huang, Professor
Role: PRINCIPAL_INVESTIGATOR
Zhejiang University
Locations
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The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023C03077
Identifier Type: -
Identifier Source: org_study_id
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