Treatment Resistant DepressionNCT06044324
Positron Emission Tomography in Transcranial Magnetic Stimulation Intervention for Treatment-resistant Depression
A study testing Repetitive Transcranial Magnetic Stimulation in people with Treatment Resistant Depression and Visual Perceptual Weakness, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment Resistant Depression, Visual Perceptual Weakness
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- Right-handedness.
- Han Chinese.
- Signed a written informed consent, willing to participate in the study and be evaluated.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
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
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.
Read more
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.
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation, PET/MRI
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Active comparator | Stimulation site: According to the localization of neural orientation navigation system, magnetic resonance data was read in Brainsight software, and three-dimensional brain reconstruction was carried out. The stimulation target was located in the coordinates of Montreal Neurological Institute (MNI), which was located in the left middle temporal (-43, -73, 10). Treatment intensity was 100% exercise threshold, continuous 10Hz stimulation, repeated 75 times, that is, 3000 pulses per treatment, 2 times a day, stimulation lasted for 4 seconds with a 26-second interval for 37.5 minutes, continuous stimulation for 5 days, 2 days rest interval, and 5 days of continuous stimulation. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| HC observation | No intervention | Collect data on healthy controls without stimulation. The subjects get clinical evaluation, blood sample collection, positron emission tomography-magnetic resonance scanning, and electrophysiological monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Suppression Index after treatment
Suppression Index (SI) defined as the difference of log10 thresholds for large versus small stimuli of gratings, is able to quantify the suppression strength. The higher the numerical value, the more severe the visual motor perception deficit.
Measured: Baseline
Change in Suppression Index after treatment
Suppression Index (SI) defined as the difference of log10 thresholds for large versus small stimuli of gratings, is able to quantify the suppression strength. The higher the numerical value, the more severe the visual motor perception deficit.
Measured: 2 weeks
Hamilton Depression Scale (24-items) Total Score Change
The Hamilton Depression Scale (24-items), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. It's considered the gold standard for rating depression severity and used frequently in clinical trials. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4. The higher scores representing more severe levels of depression. Remission is defined as HAM-D24 ≤8. A reduction of 50% or more in total score from Baseline indicates clinical response.
Measured: Baseline
Hamilton Depression Scale (24-items) Total Score Change
The Hamilton Depression Scale (24-items), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. It's considered the gold standard for rating depression severity and used frequently in clinical trials. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4. The higher scores representing more severe levels of depression. Remission is defined as HAM-D24 ≤8. A reduction of 50% or more in total score from Baseline indicates clinical response.
Measured: 2 weeks
Change in synaptic density using positron emission tomography/magnetic resonance imaging
Positron emission tomography/magnetic resonance imaging (PET/MRI) is a fusion of PET and MRI, which integrates pathophysiological changes with morphological structure. Research using PET/MRI in major depression has shown that there are alterations in the snyaptic density of certain brain regions in people with the condition and synaptic dysfunction in the dorsolateral prefrontal cortex may have implications for the downstream organization of functional networks. The SV2A radioligand [11C]UCB-H can examine snyaptic density in human brain. And brain structure, function connectivity and spectrum of metabolic substances can be measured by MRI. Overall, PET/MRI has advantages for the diagnosis of major depression and the evaluation of treatment effects.
Measured: Baseline
Change in synaptic density using positron emission tomography/magnetic resonance imaging
Positron emission tomography/magnetic resonance imaging (PET/MRI) is a fusion of PET and MRI, which integrates pathophysiological changes with morphological structure. Research using PET/MRI in major depression has shown that there are alterations in the snyaptic density of certain brain regions in people with the condition and synaptic dysfunction in the dorsolateral prefrontal cortex may have implications for the downstream organization of functional networks. The SV2A radioligand [11C]UCB-H can examine snyaptic density in human brain. And brain structure, function connectivity and spectrum of metabolic substances can be measured by MRI. Overall, PET/MRI has advantages for the diagnosis of major depression and the evaluation of treatment effects.
Measured: 2 weeks
Secondary outcomes (44)
Change in Suppression Index after treatment
Suppression Index (SI) defined as the difference of log10 thresholds for large versus small stimuli of gratings, is able to quantify the suppression strength. The higher the numerical value, the more severe the visual motor perception deficit.
Measured: 1 week
Change in Suppression Index after treatment
Suppression Index (SI) defined as the difference of log10 thresholds for large versus small stimuli of gratings, is able to quantify the suppression strength. The higher the numerical value, the more severe the visual motor perception deficit.
Measured: 6 weeks
Change in the score of Visual Analog Scale (VAS)
Subjective experience of time was measured by the VAS, which consists of a 100-mm vertical line representing the experience of time from slowest (i.e., -50 mm) to fastest (i.e., +50 mm). In this nonverbal dimensional task, subjects were asked to label how fast or slow they experienced the flow of time on the day of the survey.
Measured: Baseline
Change in the score of Visual Analog Scale (VAS)
Subjective experience of time was measured by the VAS, which consists of a 100-mm vertical line representing the experience of time from slowest (i.e., -50 mm) to fastest (i.e., +50 mm). In this nonverbal dimensional task, subjects were asked to label how fast or slow they experienced the flow of time on the day of the survey.
Measured: 1 week
Change in the score of Visual Analog Scale (VAS)
Subjective experience of time was measured by the VAS, which consists of a 100-mm vertical line representing the experience of time from slowest (i.e., -50 mm) to fastest (i.e., +50 mm). In this nonverbal dimensional task, subjects were asked to label how fast or slow they experienced the flow of time on the day of the survey.
Measured: 2 weeks
Change in the score of Visual Analog Scale (VAS)
Subjective experience of time was measured by the VAS, which consists of a 100-mm vertical line representing the experience of time from slowest (i.e., -50 mm) to fastest (i.e., +50 mm). In this nonverbal dimensional task, subjects were asked to label how fast or slow they experienced the flow of time on the day of the survey.
Measured: 6 weeks
Change in the score of Motor Agitation and Retardation Scale
The Motor Agitation and Retardation Scale (MARS) is designed to assess psychomotor deficits in depressed patients and consists of five major body categories including eyes, face, voice, limbs, and trunk. The severity of each item ranges from 1 to 4, with 4 being the most severe. It takes an estimated 10 to 15 minutes to complete the assessment. The descriptions and explanations of the items are intended to be simple and practical.
Measured: Baseline
Change in the score of Motor Agitation and Retardation Scale
The Motor Agitation and Retardation Scale (MARS) is designed to assess psychomotor deficits in depressed patients and consists of five major body categories including eyes, face, voice, limbs, and trunk. The severity of each item ranges from 1 to 4, with 4 being the most severe. It takes an estimated 10 to 15 minutes to complete the assessment. The descriptions and explanations of the items are intended to be simple and practical.
Measured: 1 week
Change in the score of Motor Agitation and Retardation Scale
The Motor Agitation and Retardation Scale (MARS) is designed to assess psychomotor deficits in depressed patients and consists of five major body categories including eyes, face, voice, limbs, and trunk. The severity of each item ranges from 1 to 4, with 4 being the most severe. It takes an estimated 10 to 15 minutes to complete the assessment. The descriptions and explanations of the items are intended to be simple and practical.
Measured: 2 weeks
Change in the score of Motor Agitation and Retardation Scale
The Motor Agitation and Retardation Scale (MARS) is designed to assess psychomotor deficits in depressed patients and consists of five major body categories including eyes, face, voice, limbs, and trunk. The severity of each item ranges from 1 to 4, with 4 being the most severe. It takes an estimated 10 to 15 minutes to complete the assessment. The descriptions and explanations of the items are intended to be simple and practical.
Measured: 6 weeks
Hamilton Depression Scale (24-items) Total Score Change
The Hamilton Depression Scale (24-items), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. It's considered the gold standard for rating depression severity and used frequently in clinical trials. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4. The higher scores representing more severe levels of depression. Remission is defined as HAM-D24 ≤8. A reduction of 50% or more in total score from Baseline indicates clinical response.
Measured: 1 weeks
Hamilton Depression Scale (24-items) Total Score Change
The Hamilton Depression Scale (24-items), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. It's considered the gold standard for rating depression severity and used frequently in clinical trials. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4. The higher scores representing more severe levels of depression. Remission is defined as HAM-D24 ≤8. A reduction of 50% or more in total score from Baseline indicates clinical response.
Measured: 6 weeks
Change in the rate of Hamilton Anxiety Scale score
Hamilton Anxiety Scale is a 17 item diagnostic questionnaire used to measure the severity of anxiety episodes in patients. Each item on the scale is rated on a 5-point scale from 0 (not present) to 4 (severe), with the total score ranging from 0 to 68. Higher scores indicate higher levels of anxiety. The HAMA-17 is often used in clinical and research settings to assess the severity of anxiety symptoms and to evaluate the effectiveness of treatments for anxiety. It is a more comprehensive version of the HAMA that includes additional items to capture a broader range of anxiety symptoms.
Measured: Baseline
Change in the rate of Hamilton Anxiety Scale score
Hamilton Anxiety Scale is a 17 item diagnostic questionnaire used to measure the severity of anxiety episodes in patients. Each item on the scale is rated on a 5-point scale from 0 (not present) to 4 (severe), with the total score ranging from 0 to 68. Higher scores indicate higher levels of anxiety. The HAMA-17 is often used in clinical and research settings to assess the severity of anxiety symptoms and to evaluate the effectiveness of treatments for anxiety. It is a more comprehensive version of the HAMA that includes additional items to capture a broader range of anxiety symptoms.
Measured: 1 week
Change in the rate of Hamilton Anxiety Scale score
Hamilton Anxiety Scale is a 17 item diagnostic questionnaire used to measure the severity of anxiety episodes in patients. Each item on the scale is rated on a 5-point scale from 0 (not present) to 4 (severe), with the total score ranging from 0 to 68. Higher scores indicate higher levels of anxiety. The HAMA-17 is often used in clinical and research settings to assess the severity of anxiety symptoms and to evaluate the effectiveness of treatments for anxiety. It is a more comprehensive version of the HAMA that includes additional items to capture a broader range of anxiety symptoms.
Measured: 2 weeks
Change in the rate of Hamilton Anxiety Scale score
Hamilton Anxiety Scale is a 17 item diagnostic questionnaire used to measure the severity of anxiety episodes in patients. Each item on the scale is rated on a 5-point scale from 0 (not present) to 4 (severe), with the total score ranging from 0 to 68. Higher scores indicate higher levels of anxiety. The HAMA-17 is often used in clinical and research settings to assess the severity of anxiety symptoms and to evaluate the effectiveness of treatments for anxiety. It is a more comprehensive version of the HAMA that includes additional items to capture a broader range of anxiety symptoms.
Measured: 6 weeks
the Chinese version of the Snaith-Hamilton Pleasure Scale
The Chinese version of the Snaith-Hamilton Pleasure Scale is a tool to assess pleasure deficit in depressed patients. A total of 14 items, each with a score of 1 to 4, will be used to calculate the total score from 14 to 56. The higher the score, the more severe the pleasure deficit.
Measured: Baseline
the Chinese version of the Snaith-Hamilton Pleasure Scale
The Chinese version of the Snaith-Hamilton Pleasure Scale is a tool to assess pleasure deficit in depressed patients. A total of 14 items, each with a score of 1 to 4, will be used to calculate the total score from 14 to 56. The higher the score, the more severe the pleasure deficit.
Measured: 1 week
the Chinese version of the Snaith-Hamilton Pleasure Scale
The Chinese version of the Snaith-Hamilton Pleasure Scale is a tool to assess pleasure deficit in depressed patients. A total of 14 items, each with a score of 1 to 4, will be used to calculate the total score from 14 to 56. The higher the score, the more severe the pleasure deficit.
Measured: 2 weeks
the Chinese version of the Snaith-Hamilton Pleasure Scale
The Chinese version of the Snaith-Hamilton Pleasure Scale is a tool to assess pleasure deficit in depressed patients. A total of 14 items, each with a score of 1 to 4, will be used to calculate the total score from 14 to 56. The higher the score, the more severe the pleasure deficit.
Measured: 6 weeks
Change in the rate of Beck Scale of Suicidal Ideation score
Beck Scale of Suicidal Ideation is a 21-item self-report instrument that detects and measures the intensity of a patient's specific attitudes, behaviors, and suicide plans during the past week. The BSI score ranges from 0 to 63, with higher scores indicating worse outcomes and lower scores indicating better outcomes.
Measured: Baseline
Change in the rate of Beck Scale of Suicidal Ideation score
Beck Scale of Suicidal Ideation is a 21-item self-report instrument that detects and measures the intensity of a patient's specific attitudes, behaviors, and suicide plans during the past week. The BSI score ranges from 0 to 63, with higher scores indicating worse outcomes and lower scores indicating better outcomes.
Measured: 1 week
Change in the rate of Beck Scale of Suicidal Ideation score
Beck Scale of Suicidal Ideation is a 21-item self-report instrument that detects and measures the intensity of a patient's specific attitudes, behaviors, and suicide plans during the past week. The BSI score ranges from 0 to 63, with higher scores indicating worse outcomes and lower scores indicating better outcomes.
Measured: 2 weeks
Change in the rate of Beck Scale of Suicidal Ideation score
Beck Scale of Suicidal Ideation is a 21-item self-report instrument that detects and measures the intensity of a patient's specific attitudes, behaviors, and suicide plans during the past week. The BSI score ranges from 0 to 63, with higher scores indicating worse outcomes and lower scores indicating better outcomes.
Measured: 6 weeks
Change in the Laukes Emotional Intensity Scale score
The Laukes Emotional Intensity Scale (LEIS) was one of the first instruments successfully used to assess emotional retardation due to SSRI. The scale is a self-report scale designed to evaluate a subject's emotional intensity rather than frequency. The assessment consists of 18 questions on a 5-point scale assessing the subject's emotional state compared to "usual". The total score ranges from -36 to 36, representing very low to very high emotional intensity.
Measured: Baseline
Change in the Laukes Emotional Intensity Scale score
The Laukes Emotional Intensity Scale (LEIS) was one of the first instruments successfully used to assess emotional retardation due to SSRI. The scale is a self-report scale designed to evaluate a subject's emotional intensity rather than frequency. The assessment consists of 18 questions on a 5-point scale assessing the subject's emotional state compared to "usual". The total score ranges from -36 to 36, representing very low to very high emotional intensity.
Measured: 1 week
Change in the Laukes Emotional Intensity Scale score
The Laukes Emotional Intensity Scale (LEIS) was one of the first instruments successfully used to assess emotional retardation due to SSRI. The scale is a self-report scale designed to evaluate a subject's emotional intensity rather than frequency. The assessment consists of 18 questions on a 5-point scale assessing the subject's emotional state compared to "usual". The total score ranges from -36 to 36, representing very low to very high emotional intensity.
Measured: 2 weeks
Change in the Laukes Emotional Intensity Scale score
The Laukes Emotional Intensity Scale (LEIS) was one of the first instruments successfully used to assess emotional retardation due to SSRI. The scale is a self-report scale designed to evaluate a subject's emotional intensity rather than frequency. The assessment consists of 18 questions on a 5-point scale assessing the subject's emotional state compared to "usual". The total score ranges from -36 to 36, representing very low to very high emotional intensity.
Measured: 6 weeks
Change in the Clinically Useful Depression Outcome Scale-Mixed Subscale score
The Useful Depression Outcome Scale-Mixed Subscale (CUDOS-M) is a revised scale based on the CUDOS with items added and subtracted, combining the criteria for evaluating typical manic/hypomanic episodes and depressive episodes; it is a self-assessment scale used for prognostic assessment of patients with depressive disorders with 13 rating items. Total score from 0 to 52, the higher the score the more serious the situation is.
Measured: Baseline
Change in the score of THINC-it
THINC-it is a computerized cognitive screening tool that is designed to assess cognitive function in adults. THINC-it stands for "THINking Clearly," and it consist of 1 subjective (5-item Cognitive Impairment in Depression Questionnaire) and 4 objective (Choice Reaction Time, 1-Back Memory Task, Digit Symbol Replacement Test, and the Connectivity Test). The tool is administered on a tablet or computer, and it takes approximately 20 minutes to complete.
Measured: Baseline
Change in the score of THINC-it
THINC-it is a computerized cognitive screening tool that is designed to assess cognitive function in adults. THINC-it stands for "THINking Clearly," and it consist of 1 subjective (5-item Cognitive Impairment in Depression Questionnaire) and 4 objective (Choice Reaction Time, 1-Back Memory Task, Digit Symbol Replacement Test, and the Connectivity Test). The tool is administered on a tablet or computer, and it takes approximately 20 minutes to complete.
Measured: 1 week
Change in the score of THINC-it
THINC-it is a computerized cognitive screening tool that is designed to assess cognitive function in adults. THINC-it stands for "THINking Clearly," and it consist of 1 subjective (5-item Cognitive Impairment in Depression Questionnaire) and 4 objective (Choice Reaction Time, 1-Back Memory Task, Digit Symbol Replacement Test, and the Connectivity Test). The tool is administered on a tablet or computer, and it takes approximately 20 minutes to complete.
Measured: 2 weeks
Change in the score of THINC-it
THINC-it is a computerized cognitive screening tool that is designed to assess cognitive function in adults. THINC-it stands for "THINking Clearly," and it consist of 1 subjective (5-item Cognitive Impairment in Depression Questionnaire) and 4 objective (Choice Reaction Time, 1-Back Memory Task, Digit Symbol Replacement Test, and the Connectivity Test). The tool is administered on a tablet or computer, and it takes approximately 20 minutes to complete.
Measured: 6 weeks
Change in electroencephalogram
Electroencephalogram is collected from 64 electrodes. EEG can be used to identify patterns of brain activity that are associated with the condition and to inform treatment decisions. EEG can be a useful tool for identifying patterns of brain activity that are associated with TRD and for guiding treatment decisions. Neurofeedback and TMS are two approaches that have shown promise in the treatment of TRD. several parameters are analyzed to identify patterns of brain activity that may be associated with the condition. These parameters include: Alpha power, Beta power, Theta power, Delta power, Coherence, and more.
Measured: Baseline
Change in electroencephalogram
Electroencephalogram is collected from 64 electrodes. EEG can be used to identify patterns of brain activity that are associated with the condition and to inform treatment decisions. EEG can be a useful tool for identifying patterns of brain activity that are associated with TRD and for guiding treatment decisions. Neurofeedback and TMS are two approaches that have shown promise in the treatment of TRD. several parameters are analyzed to identify patterns of brain activity that may be associated with the condition. These parameters include: Alpha power, Beta power, Theta power, Delta power, Coherence, and more.
Measured: 1 week
Change in electroencephalogram
Electroencephalogram is collected from 64 electrodes. EEG can be used to identify patterns of brain activity that are associated with the condition and to inform treatment decisions. EEG can be a useful tool for identifying patterns of brain activity that are associated with TRD and for guiding treatment decisions. Neurofeedback and TMS are two approaches that have shown promise in the treatment of TRD. several parameters are analyzed to identify patterns of brain activity that may be associated with the condition. These parameters include: Alpha power, Beta power, Theta power, Delta power, Coherence, and more.
Measured: 2 weeks
Change in electroencephalogram
Electroencephalogram is collected from 64 electrodes. EEG can be used to identify patterns of brain activity that are associated with the condition and to inform treatment decisions. EEG can be a useful tool for identifying patterns of brain activity that are associated with TRD and for guiding treatment decisions. Neurofeedback and TMS are two approaches that have shown promise in the treatment of TRD. several parameters are analyzed to identify patterns of brain activity that may be associated with the condition. These parameters include: Alpha power, Beta power, Theta power, Delta power, Coherence, and more.
Measured: 6 weeks
Change in the TMS-EEG data
Transcranial magnetic stimulation induces changes in cortical plasticity that can persist long after the end of stimulation. EEG is the sum of excitatory and inhibitory postsynaptic potentials, reflecting the rhythmic activity of neurons in the cerebral cortex.The stimulus response characteristics of TMS-EEG can be used to measure the cortical effects induced by TMS, to explore the functions of various brain regions, to correlate the causal relationship of inter-brain interactions, as well as to diagnose and treat depression based on abnormal response characteristics.
Measured: Baseline
Change in the TMS-EEG data
Transcranial magnetic stimulation induces changes in cortical plasticity that can persist long after the end of stimulation. EEG is the sum of excitatory and inhibitory postsynaptic potentials, reflecting the rhythmic activity of neurons in the cerebral cortex.The stimulus response characteristics of TMS-EEG can be used to measure the cortical effects induced by TMS, to explore the functions of various brain regions, to correlate the causal relationship of inter-brain interactions, as well as to diagnose and treat depression based on abnormal response characteristics.
Measured: 1 week
Change in the TMS-EEG data
Transcranial magnetic stimulation induces changes in cortical plasticity that can persist long after the end of stimulation. EEG is the sum of excitatory and inhibitory postsynaptic potentials, reflecting the rhythmic activity of neurons in the cerebral cortex.The stimulus response characteristics of TMS-EEG can be used to measure the cortical effects induced by TMS, to explore the functions of various brain regions, to correlate the causal relationship of inter-brain interactions, as well as to diagnose and treat depression based on abnormal response characteristics.
Measured: 2 weeks
IL-6 level
Detection of serum IL-6 levels using flow cytometry. The normal value is 0-5.30 pg/ml. There is a goodcorrelation between depression and elevated serum IL-6 levels.
Measured: Baseline
IL-6 level
Detection of serum IL-6 levels using flow cytometry. The normal value is 0-5.30 pg/ml. There is a goodcorrelation between depression and elevated serum IL-6 levels.
Measured: 1 week
IL-6 level
Detection of serum IL-6 levels using flow cytometry. The normal value is 0-5.30 pg/ml. There is a goodcorrelation between depression and elevated serum IL-6 levels.
Measured: 2 weeks
IL-6 level
Detection of serum IL-6 levels using flow cytometry. The normal value is 0-5.30 pg/ml. There is a goodcorrelation between depression and elevated serum IL-6 levels.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Nov 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044324
- Sponsor's protocol ID
- IIT20240155C-R1
- Status last verified
- Oct 2024
- First submitted
- 4 Sep 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06044324
- Acronym / sponsor ID
- IIT20240155C-R1
- Keywords
- Repetitive Transcranial Magnetic Stimulation, PET/MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Active comparator | Device: Repetitive Transcranial Magnetic StimulationStimulation site: According to the localization of neural orientation navigation system, magnetic resonance data was read in Brainsight software, and three-dimensional brain reconstruction was carried out. The stimulation target was located in the coordinates of Montreal Neurological Institute (MNI), which was located in the left middle temporal (-43, -73, 10). Treatment intensity was 100% exercise threshold, continuous 10Hz stimulation, repeated 75 times, that is, 3000 pulses per treatment, 2 times a day, stimulation lasted for 4 seconds with a 26-second interval for 37.5 minutes, continuous stimulation for 5 days, 2 days rest interval, and 5 days of continuous stimulation. |
| HC observation | No intervention | –Collect data on healthy controls without stimulation. The subjects get clinical evaluation, blood sample collection, positron emission tomography-magnetic resonance scanning, and electrophysiological monitoring. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationParticipants 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. | Device | Repetitive Transcranial Magnetic Stimulation |
Primary outcome
Change in Suppression Index after treatment
Time frame: Baseline
Suppression Index (SI) defined as the difference of log10 thresholds for large versus small stimuli of gratings, is able to quantify the suppression strength. The higher the numerical value, the more severe the visual motor perception deficit.
Change in Suppression Index after treatment
Time frame: 2 weeks
Suppression Index (SI) defined as the difference of log10 thresholds for large versus small stimuli of gratings, is able to quantify the suppression strength. The higher the numerical value, the more severe the visual motor perception deficit.
Hamilton Depression Scale (24-items) Total Score Change
Time frame: Baseline
The Hamilton Depression Scale (24-items), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. It's considered the gold standard for rating depression severity and used frequently in clinical trials. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4. The higher scores representing more severe levels of depression. Remission is defined as HAM-D24 ≤8. A reduction of 50% or more in total score from Baseline indicates clinical response.
Hamilton Depression Scale (24-items) Total Score Change
Time frame: 2 weeks
The Hamilton Depression Scale (24-items), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. It's considered the gold standard for rating depression severity and used frequently in clinical trials. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4. The higher scores representing more severe levels of depression. Remission is defined as HAM-D24 ≤8. A reduction of 50% or more in total score from Baseline indicates clinical response.
Change in synaptic density using positron emission tomography/magnetic resonance imaging
Time frame: Baseline
Positron emission tomography/magnetic resonance imaging (PET/MRI) is a fusion of PET and MRI, which integrates pathophysiological changes with morphological structure. Research using PET/MRI in major depression has shown that there are alterations in the snyaptic density of certain brain regions in people with the condition and synaptic dysfunction in the dorsolateral prefrontal cortex may have implications for the downstream organization of functional networks. The SV2A radioligand [11C]UCB-H can examine snyaptic density in human brain. And brain structure, function connectivity and spectrum of metabolic substances can be measured by MRI. Overall, PET/MRI has advantages for the diagnosis of major depression and the evaluation of treatment effects.
Change in synaptic density using positron emission tomography/magnetic resonance imaging
Time frame: 2 weeks
Positron emission tomography/magnetic resonance imaging (PET/MRI) is a fusion of PET and MRI, which integrates pathophysiological changes with morphological structure. Research using PET/MRI in major depression has shown that there are alterations in the snyaptic density of certain brain regions in people with the condition and synaptic dysfunction in the dorsolateral prefrontal cortex may have implications for the downstream organization of functional networks. The SV2A radioligand [11C]UCB-H can examine snyaptic density in human brain. And brain structure, function connectivity and spectrum of metabolic substances can be measured by MRI. Overall, PET/MRI has advantages for the diagnosis of major depression and the evaluation of treatment effects.
44 secondary outcomes
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
Change in the rate of Hamilton Anxiety Scale score
Time frame: Baseline
Change in the rate of Hamilton Anxiety Scale score
Time frame: 1 week
Change in the rate of Hamilton Anxiety Scale score
Time frame: 2 weeks
Change in the rate of Hamilton Anxiety Scale score
Time frame: 6 weeks
the Chinese version of the Snaith-Hamilton Pleasure Scale
Time frame: Baseline
the Chinese version of the Snaith-Hamilton Pleasure Scale
Time frame: 1 week
the Chinese version of the Snaith-Hamilton Pleasure Scale
Time frame: 2 weeks
the Chinese version of the Snaith-Hamilton Pleasure Scale
Time frame: 6 weeks
Change in the rate of Beck Scale of Suicidal Ideation score
Time frame: Baseline
Change in the rate of Beck Scale of Suicidal Ideation score
Time frame: 1 week
Change in the rate of Beck Scale of Suicidal Ideation score
Time frame: 2 weeks
Change in the rate of Beck Scale of Suicidal Ideation score
Time frame: 6 weeks
Change in the Laukes Emotional Intensity Scale score
Time frame: Baseline
Change in the Laukes Emotional Intensity Scale score
Time frame: 1 week
Change in the Laukes Emotional Intensity Scale score
Time frame: 2 weeks
Change in the Laukes Emotional Intensity Scale score
Time frame: 6 weeks
Change in the Clinically Useful Depression Outcome Scale-Mixed Subscale score
Time frame: Baseline
Change in the score of THINC-it
Time frame: Baseline
Change in the score of THINC-it
Time frame: 1 week
Change in the score of THINC-it
Time frame: 2 weeks
Change in the score of THINC-it
Time frame: 6 weeks
Change in electroencephalogram
Time frame: Baseline
Change in electroencephalogram
Time frame: 1 week
Change in electroencephalogram
Time frame: 2 weeks
Change in electroencephalogram
Time frame: 6 weeks
Change in the TMS-EEG data
Time frame: Baseline
Change in the TMS-EEG data
Time frame: 1 week
Change in the TMS-EEG data
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Treatment Resistant Depression and Visual Perceptual Weakness, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Suppression Index after treatment (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.