Early Identification of TRD and Construction and Clinical Validation of NTBS Precision Technology

Summary

The goal of this clinical trial is to learn about the characteristics, identify early and intervene effectively in time in Treatment-Resistant Depression. The main questions are: • TRD is difficult to identify early and lacks objective detection indicators; • Existing treatment strategies for TRD are associated with side effects and high treatment resistance; • Current non-invasive brain stimulation therapy lacks precision.

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.

Conditions

• Treatment-Resistant Depression

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

Motor cortex stimulation

Receive stimulation in the motor cortex stimulation instead of deep brain.

DEVICE

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.

Sponsors & Collaborators

• Zhejiang University

  collaborator OTHER

• Kangci Hospital of Jiaxing

  collaborator UNKNOWN

• Wenzhou Seventh People's Hospital

  collaborator OTHER_GOV

• Lishui Second People's Hospital

  collaborator UNKNOWN

• Huzhou Third People's Hospital

  collaborator OTHER

• Binjiang Institute of Zhejiang University

  collaborator UNKNOWN

• Zhejiang Newways Medical Technology Co., Ltd

  collaborator UNKNOWN

• Hangzhou Lingnao Technology Co., Ltd

  collaborator UNKNOWN

• First Affiliated Hospital of Zhejiang University

  lead OTHER

Principal Investigators

• Manli Huang, Professor · Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• China

Study Locations