Clinical trial NCT06044324: Positron Emission Tomography in Transcranial Magnetic Stimulation Intervention for Treatment-resistant Depression
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Treatment Resistant Depression
Visual Perceptual Weakness
Keywords: Repetitive Transcranial Magnetic Stimulation
PET/MRI
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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%.
2. 24-item Hamilton Depression Scale (HAMD-24) ≥ 20.
3. Normal or corrected to normal vision.
4. Ability to complete spatial suppression psychophysical experiment.
5. education background above the college degree.
6. Age 18-45 years, regardless of gender.
7. Right-handedness.
8. Han Chinese.
9. Signed a written informed consent, willing to participate in the study and be evaluated.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Suppression Index after treatment
timeFrame: Baseline
measure: Change in Suppression Index after treatment
timeFrame: 2 weeks
measure: Hamilton Depression Scale (24-items) Total Score Change
timeFrame: Baseline
measure: Hamilton Depression Scale (24-items) Total Score Change
timeFrame: 2 weeks
measure: Change in synaptic density using positron emission tomography/magnetic resonance imaging
timeFrame: Baseline
measure: Change in synaptic density using positron emission tomography/magnetic resonance imaging
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in Suppression Index after treatment
timeFrame: 1 week
measure: Change in Suppression Index after treatment
timeFrame: 6 weeks
measure: Change in the score of Visual Analog Scale (VAS)
timeFrame: Baseline
measure: Change in the score of Visual Analog Scale (VAS)
timeFrame: 1 week
measure: Change in the score of Visual Analog Scale (VAS)
timeFrame: 2 weeks
measure: Change in the score of Visual Analog Scale (VAS)
timeFrame: 6 weeks
measure: Change in the score of Motor Agitation and Retardation Scale
timeFrame: Baseline
measure: Change in the score of Motor Agitation and Retardation Scale
timeFrame: 1 week
measure: Change in the score of Motor Agitation and Retardation Scale
timeFrame: 2 weeks
measure: Change in the score of Motor Agitation and Retardation Scale
timeFrame: 6 weeks
measure: Hamilton Depression Scale (24-items) Total Score Change
timeFrame: 1 weeks
measure: Hamilton Depression Scale (24-items) Total Score Change
timeFrame: 6 weeks
measure: Change in the rate of Hamilton Anxiety Scale score
timeFrame: Baseline
measure: Change in the rate of Hamilton Anxiety Scale score
timeFrame: 1 week
measure: Change in the rate of Hamilton Anxiety Scale score
timeFrame: 2 weeks
measure: Change in the rate of Hamilton Anxiety Scale score
timeFrame: 6 weeks
measure: the Chinese version of the Snaith-Hamilton Pleasure Scale
timeFrame: Baseline
measure: the Chinese version of the Snaith-Hamilton Pleasure Scale
timeFrame: 1 week
measure: the Chinese version of the Snaith-Hamilton Pleasure Scale
timeFrame: 2 weeks
measure: the Chinese version of the Snaith-Hamilton Pleasure Scale
timeFrame: 6 weeks
measure: Change in the rate of Beck Scale of Suicidal Ideation score
timeFrame: Baseline
measure: Change in the rate of Beck Scale of Suicidal Ideation score
timeFrame: 1 week
measure: Change in the rate of Beck Scale of Suicidal Ideation score
timeFrame: 2 weeks
measure: Change in the rate of Beck Scale of Suicidal Ideation score
timeFrame: 6 weeks
measure: Change in the Laukes Emotional Intensity Scale score
timeFrame: Baseline
measure: Change in the Laukes Emotional Intensity Scale score
timeFrame: 1 week
measure: Change in the Laukes Emotional Intensity Scale score
timeFrame: 2 weeks
measure: Change in the Laukes Emotional Intensity Scale score
timeFrame: 6 weeks
measure: Change in the Clinically Useful Depression Outcome Scale-Mixed Subscale score
timeFrame: Baseline
measure: Change in the score of THINC-it
timeFrame: Baseline
measure: Change in the score of THINC-it
timeFrame: 1 week
measure: Change in the score of THINC-it
timeFrame: 2 weeks
measure: Change in the score of THINC-it
timeFrame: 6 weeks
measure: Change in electroencephalogram
timeFrame: Baseline
measure: Change in electroencephalogram
timeFrame: 1 week
measure: Change in electroencephalogram
timeFrame: 2 weeks
measure: Change in electroencephalogram
timeFrame: 6 weeks
measure: Change in the TMS-EEG data
timeFrame: Baseline
measure: Change in the TMS-EEG data
timeFrame: 1 week
measure: Change in the TMS-EEG data
timeFrame: 2 weeks
measure: IL-6 level
timeFrame: Baseline
measure: IL-6 level
timeFrame: 1 week
measure: IL-6 level
timeFrame: 2 weeks
measure: IL-6 level
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References: