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

NARecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

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.

Trial Locations (1)

310000

RECRUITING

The First Affiliated Hospital of Zhejiang University, Hangzhou

All Listed Sponsors
collaborator

Zhejiang University

OTHER

collaborator

Kangci Hospital of Jiaxing

UNKNOWN

collaborator

Wenzhou Seventh People's Hospital

OTHER_GOV

collaborator

Lishui Second People's Hospital

UNKNOWN

collaborator

Huzhou Third People's Hospital

OTHER

collaborator

Binjiang Institute of Zhejiang University

UNKNOWN

collaborator

Zhejiang Newways Medical Technology Co., Ltd

UNKNOWN

collaborator

Hangzhou Lingnao Technology Co., Ltd

UNKNOWN

lead

First Affiliated Hospital of Zhejiang University

OTHER