Menu
Enrolling by invitation NCT06044324

Positron Emission Tomography in Transcranial Magnetic Stimulation Intervention for Treatment-resistant Depression

No phase Interventional Treatment Resistant Depression Visual Perceptual Weakness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repetitive Transcranial Magnetic Stimulation.
Who it may be relevant to
Registry conditions: Treatment Resistant Depression, Visual Perceptual Weakness. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Study on the Efficacy and Safety of Transcranial Magnetic Stimulation Intervention for Treatment-Resistant Depression Guided by Positron Emission Tomography Imaging

Overview

Major depressive disorder (MDD) exhibit reduced visual motor perception, which affects prognosis. Metabolic substance changes and abnormal neural activity in the middle temporal visual area (MT) mediate this perceptual dysfunction. The main questions are: •there is no conclusive evidence of impairment of visual motion suppression in treatment-resistant depression (TRD); •it is unknown that functional abnormalities in the MT of TRD patients mediate possible changes in visual perception •lack of treatment for deficit in visual motor perception; •mechanisms behind the intervention process need to be explored. The goal of this clinical trial is to understand the function of visual motor perception in TRD, to validate the effect of the MT on visual motion perception and to explore the effectiveness of the intervention as well as the neurophysiological mechanisms. This study was planned to •explore any differences in visual motor perception and function of MT between TRD and healthy controls; •analyze the influence of neurobiological changes in MT and related brain regions on visual motion perception; •investigate the effects of rTMS intervention in MT for treatment of impaired visual perception function in TRD; •studying potential therapeutic mechanisms by PET/MRI imaging. Participants will divide into TRD group and HC group. Clinical symptoms, scales, visual perception suppression index, PET/MRI, electrophysiology and other clinical data were collected at baseline for both two groups. TRD group received high-frequency rTMS stimulation targeting the MT. Besides, psychological scales, visual suppression index, PET/MRI, electrophysiology and other clinical data were collected during the intervention and after treatment. The researchers will •compare the differences in visual perceptual function and neurobiological characteristics between the TRD group and the HC group in baseline; •analyze the impact of MT and related brain regions in visual motion perception; •compare the suppression index before and after intervention in TRD to discuss the feasibility of rTMS stimulation targeting the MT to improve visual motion perception abnormalities；•utilize the changes in clinical data of PET/MRI and electrophysiology before and after the treatment of TRD group to explore the possible underlying mechanisms during the treatment process.

Interventions

  • Device Repetitive Transcranial Magnetic Stimulation
    Participants in the active stimulation group will receive the high frequency rTMS to left middle temporal visual area. The left middle temporal visual area will be targeted utilizing the neuronavigation system. Stimulation intensity will be standardized at 100% of RMT. Stimulation will be delivered to the left middle temporal visual area using an NTK-TMS-II100 TMS device,is compatible with the Brainsight TMS navigation system.

Primary outcome measures

  • Change in Suppression Index after treatment [Time frame: Baseline]
  • Change in Suppression Index after treatment [Time frame: 2 weeks]
  • Hamilton Depression Scale (24-items) Total Score Change [Time frame: Baseline]
  • Hamilton Depression Scale (24-items) Total Score Change [Time frame: 2 weeks]
  • Change in synaptic density using positron emission tomography/magnetic resonance imaging [Time frame: Baseline]
  • Change in synaptic density using positron emission tomography/magnetic resonance imaging [Time frame: 2 weeks]
Secondary outcome measures (12)
  • Change in Suppression Index after treatment [Time frame: 1 week]
  • Change in Suppression Index after treatment [Time frame: 6 weeks]
  • Change in the score of Visual Analog Scale (VAS) [Time frame: Baseline]
  • Change in the score of Visual Analog Scale (VAS) [Time frame: 1 week]
  • Change in the score of Visual Analog Scale (VAS) [Time frame: 2 weeks]
  • Change in the score of Visual Analog Scale (VAS) [Time frame: 6 weeks]
  • Change in the score of Motor Agitation and Retardation Scale [Time frame: Baseline]
  • Change in the score of Motor Agitation and Retardation Scale [Time frame: 1 week]
  • Change in the score of Motor Agitation and Retardation Scale [Time frame: 2 weeks]
  • Change in the score of Motor Agitation and Retardation Scale [Time frame: 6 weeks]
  • Hamilton Depression Scale (24-items) Total Score Change [Time frame: 1 weeks]
  • Hamilton Depression Scale (24-items) Total Score Change [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

  • Receive two or more adequate doses and courses of antidepressant drugs in different mechanisms that were not effective and had been stable for more than 6 weeks on antidepressant medication prior to enrollment, with non-responsiveness defined as a decrease in HAMD-24 score of <50%.
  • 24-item Hamilton Depression Scale (HAMD-24) ≥ 20.
  • Normal or corrected to normal vision.
  • Ability to complete spatial suppression psychophysical experiment.
  • education background above the college degree.
  • Age 18-45 years, regardless of gender.
  • Right-handedness.
  • Han Chinese.
  • Signed a written informed consent, willing to participate in the study and be evaluated.

Exclusion criteria

  • Co-morbid other mental disorders, including: schizophrenia, mental retardation, substance dependence, etc.
  • Patients with metal objects in the body or with other contraindications to PET-MRI scanning
  • Patients with severe or unstable somatic diseases
  • Women during pregnancy or lactation, and women of childbearing age with positive urine HCG test results during the screening period
  • Benzodiazepines were taken during the experimental period
  • Other conditions that, in the opinion of the investigator, exist that make participation in this clinical trial inappropriate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Zhejiang University — Hangzhou

Identifiers

NCT: NCT06044324 · IIT20240155C-R1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗