SchizophreniaNCT05137158
iTBS on Negative Symptoms and Cognitive Function in Schizophrenia
A study testing Intermittent theta burst stimulation in people with Schizophrenia, run by Central South University at 1 site in China.
Trial summary
The negative symptoms and cognitive deficits are common in patients with schizophrenia, and do not respond well to antipsychotics. The effective treatments for negative symptoms and cognitive impairment are still to be explored. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2022to 14 Jun 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with schizophrenia in accordance with DSM-5
- The disease duration ≤8 years
- Received a steady dose of antipsychotic medication for least 4 weeks
- The Global Deficit Score of MCCB ≥0.5 or the PANSS negative subscore ≥20
- No obvious extrapyramidal side effects caused by antipsychotic drugs
- Informed Consent
Who cannot join
- Diagnosed with other mental disease in accordance with DSM-5
- Combined with other severe physiological disease
- Used antidepressants, mood stabilizer, or other psychoactive substances before
- Drug or alcohol abuse
- Pregnant or lactating
- Contraindication to rTMS
- Received rTMS or electroconvulsive therapy in the past 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intermittent Theta Burst Stimulation on Negative Symptoms And Cognitive Function in Schizophrenia
The negative symptoms and cognitive deficits are common in patients with schizophrenia, and do not respond well to antipsychotics. The effective treatments for negative symptoms and cognitive impairment are still to be explored. rTMS is a safe and non-invasive physical treatment, some studies has been indicated that the high frequency rTMS could increase the excitability of cortex, and has potentials to improve negative symptoms and cognitive function in schizophrenia. In this study, we explore the effects of iTBS on negative symptoms and cognitive function based on identifying the brain network connection of schizophrenia symptoms.
Read the detailed description
The negative symptoms and cognitive deficits are two core symptoms in patients with schizophrenia, and do not respond well to antipsychotics. There are many researches on the biological mechanism of these two symptoms, and some studies indicated that these two symptoms maybe related to the dysfunction of prefrontal cortex and deficiency of dopamine. rTMS is a safe and non-invasive physical treatment, some studies has been indicated that the high frequency rTMS could increase the excitability of cortex, and has potentials to improve negative symptoms and cognitive function in schizophrenia.Therefore, this study explore the efficacy of iTBS on negative symptoms and cognitive deficits in schizophrenia based on identifying the brain network connection of schizophrenia symptoms.
Firstly, we have used neuroimaging to find the left prefrontal cortex that is responsible for negative symptoms and cognitive function in schizophrenia. Then,we design this randomized double-blind sham-controlled clinical trial. Patients with schizophrenia will be randomly treated with iTBS or sham condition to the left dorsolateral prefrontal cortex(L-DLPFC) for continuous 10 days, theL-DLPFC will be targeted utilizing the localite neuronavigation system. The follow-ups are set at baseline, the 11th day and the 30th day after the end of treatment. The main outcome measures include the change in MCCB score, PANSS score, SANS score, SAPS score and the resting-state functional magnetic resonance imaging data.
- Conditions
- Schizophrenia
- Being tested
- Intermittent theta burst stimulation, Sham stimulation
- Keywords
- Schizophrenia, iTBS, Negative Symptom, Cognitive function
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta burst stimulationDevice
Intermittent theta burst stimulation(iTBS) on the left DLPFC, the left DLPFC will be targeted utilizing the localite neuronavigation system. The stimulation intensity is set at 80% of resting motor threshold(RMT), and the other parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 600 pulses per session, total duration of 3 minutes and 20 seconds.
Sham stimulationDevice
The same procedure will be performed in sham group including the RMT assessment and the neuronavigation system for target localization, but the sham coil will vertical to the brain surface and deliver a very slight magnetic field, which have the same appearance and sound, and provide the same tactile sensations as the active coils.
| Study group | Role | What they receive |
|---|---|---|
| iTBS stimulation | Experimental | The patients in iTBS stimulation group will receive iTBS stimulation on the target of the left dorsolateral prefrontal cortex for 10 consecutive days and 3 times per day.There will have at least 30 minutes interval between each intervention. Receives: Device: Intermittent theta burst stimulation |
| Sham stimulation | Sham comparator | The participants in sham stimulation will receive sham stimulation, as the coil vertical to the brain surface, for 10 consecutive days and 3 times per day.There will have at least 30 minutes interval between each intervention. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MCCB
The MATRICS Consensus Cognitive Battery,It can be used for cognitive assessment of schizophrenia, bipolar disorder and other neuropsychiatric diseases,The MCCB covers nine cognitive domains including attention, information processing speed, verbal learning and memory, visual learning and memory, spatial working memory, reasoning, problem solving, social cognition, executive function and fine motor. The working memory domain does not include verbal working memory because the Chinese language would not make feasible the inclusion of the LNS test.
Measured: From baseline to 11days and the 30th day after the end of stimulation
Change in Positive and Negative Symptm Scale(PANSS) score
The scale to assess the severity of symptoms in schizophrenia.It is an evaluation scale of 30 disparate items scored from 1 to 7 for psychopathological symptoms observed in patients presenting psychotic syndromes, especially schizophrenic states.Three scores obtained with this scale are generally calculated for evaluating three dimensions of the syndrome: positive, negative and general psychopathology, as part of a categorial or dimensional perspective.The minimum value is 30 points, and the maximum value is 210 points.The higher the score, the more severe the relevant symptom is.
Measured: From baseline to 11days and the 30th day after the end of stimulation
Change in Scale for Assessment of Positive Symptoms(SAPS) score
This scale is used to assess the severity of positive symptoms in schizophrenia. Evaluating four dimensions of the positive symptoms including hallucination, delusion, strange behavior and disorders of the positive thinking form.There are 34 items in the scale, which are divided into four subscales and graded on a six-point scale. The total score of the scale is the sum of 34 individual items, reflecting the severity of positive symptoms. The score range is 0-170, the higher the score, the more severe the symptoms are. The total score of the comprehensive evaluation is the sum of the individual score of the overall evaluation item of the four subscales, which also reflects the severity of positive symptoms, the score range is 0-20. The comprehensive evaluation score of the subscale is the single score of the overall evaluation item of the four subscales, specifically reflecting the severity of the four dimensions of the positive symptoms, the score range is 0-5.
Measured: From baseline to 11days and the 30th day after the end of stimulation
Change in Scale for Assessment of Negative Symptoms(SANS) score
This scale is used to assess the severity of negative symptoms in schizophrenia. Evaluating five dimensions of the negative symptoms including apathy, poverty of thought, abulia, social withdrawal and disorders of attention.There are 24 items in the scale, which are divided into five subscales and graded on a six-point scale. The total score of the scale is the sum of 24 individual items, reflecting the severity of positive symptoms. The score range is 0-120, the higher the score, the more severe the negative symptoms are. The total score of the comprehensive evaluation is the sum of the individual score of the overall evaluation item of the five subscales, which also reflects the severity of negative symptoms, the score range is 0-25. The comprehensive evaluation score of the subscale is the single score of the overall evaluation item of the five subscales, specifically reflecting the severity of the five dimensions of the negative symptoms, the score range is 0-5.
Measured: From baseline to 11days and the 30th day after the end of stimulation
The data of resting-state functional magnetic resonance imaging
All patients undergo head MRI scans in Philips Achieva 3.0 T scanner and SIEMENS Prisma 3.0 T scanner.
Measured: From baseline to 11days and the 30th day after the end of stimulation
Secondary outcomes (2)
Change in Treatment Emergent Symptom Scale(TESS) score
The scale is used to assess the side effects of various psychotropic drugs in adult patients. Evaluation is based on patient statements, physical examination and laboratory results.The 34 symptoms were summarized into 6 groups of symptoms, including behavioral adverse reactions, laboratory tests, nervous system reactions, autonomic nervous system symptoms, cardiovascular system reactions and others.The scale evaluation requires a three-pronged assessment of each symptom: severity, the relationship between the symptom and the medication, and the treatment.
Measured: From baseline to 11days and the 30th day after the end of stimulation
The blood sample
About 20ml blood samples were collected intravenously to test blood routine, liver and kidney function, electrolytes and other routine tests.
Measured: From baseline to 11days and the 30th day after the end of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start15 Oct 2022
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Model description
- Sixty participants are randomly and equally divided into intervention group or sham stimulation group according to the predetermined random number list.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
- Investigators
- Renrong Wu, Prof, Principal investigator, The Second Xiangya Hospital of Central South University Psychiatry Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137158
- Sponsor's protocol ID
- WU202110TBS
- Status last verified
- Aug 2024
- First submitted
- 9 Nov 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intermittent Theta Burst Stimulation on Negative Symptoms And Cognitive Function in Schizophrenia
- ClinicalTrials.gov ID
- NCT05137158
- Acronym / sponsor ID
- WU202110TBS
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, iTBS, Negative Symptom, Cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 30 Nov 2021 (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.
The negative symptoms and cognitive deficits are common in patients with schizophrenia, and do not respond well to antipsychotics. The effective treatments for negative symptoms and cognitive impairment are still to be explored. rTMS is a safe and non-invasive physical treatment, some studies has been indicated that the high frequency rTMS could increase the excitability of cortex, and has potentials to improve negative symptoms and cognitive function in schizophrenia. In this study, we explore the effects of iTBS on negative symptoms and cognitive function based on identifying the brain network connection of schizophrenia symptoms.
Detailed description
The negative symptoms and cognitive deficits are two core symptoms in patients with schizophrenia, and do not respond well to antipsychotics. There are many researches on the biological mechanism of these two symptoms, and some studies indicated that these two symptoms maybe related to the dysfunction of prefrontal cortex and deficiency of dopamine. rTMS is a safe and non-invasive physical treatment, some studies has been indicated that the high frequency rTMS could increase the excitability of cortex, and has potentials to improve negative symptoms and cognitive function in schizophrenia.Therefore, this study explore the efficacy of iTBS on negative symptoms and cognitive deficits in schizophrenia based on identifying the brain network connection of schizophrenia symptoms.
Firstly, we have used neuroimaging to find the left prefrontal cortex that is responsible for negative symptoms and cognitive function in schizophrenia. Then,we design this randomized double-blind sham-controlled clinical trial. Patients with schizophrenia will be randomly treated with iTBS or sham condition to the left dorsolateral prefrontal cortex(L-DLPFC) for continuous 10 days, theL-DLPFC will be targeted utilizing the localite neuronavigation system. The follow-ups are set at baseline, the 11th day and the 30th day after the end of treatment. The main outcome measures include the change in MCCB score, PANSS score, SANS score, SAPS score and the resting-state functional magnetic resonance imaging data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sixty participants are randomly and equally divided into intervention group or sham stimulation group according to the predetermined random number list.
| Arm | Type | Receives |
|---|---|---|
| iTBS stimulation | Experimental | Device: Intermittent theta burst stimulationThe patients in iTBS stimulation group will receive iTBS stimulation on the target of the left dorsolateral prefrontal cortex for 10 consecutive days and 3 times per day.There will have at least 30 minutes interval between each intervention. |
| Sham stimulation | Sham comparator | Device: Sham stimulationThe participants in sham stimulation will receive sham stimulation, as the coil vertical to the brain surface, for 10 consecutive days and 3 times per day.There will have at least 30 minutes interval between each intervention. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with schizophrenia in accordance with DSM-5
- The disease duration ≤8 years
- Received a steady dose of antipsychotic medication for least 4 weeks
- The Global Deficit Score of MCCB ≥0.5 or the PANSS negative subscore ≥20
- No obvious extrapyramidal side effects caused by antipsychotic drugs
Key exclusion criteria (7 listed)
- Diagnosed with other mental disease in accordance with DSM-5
- Combined with other severe physiological disease
- Used antidepressants, mood stabilizer, or other psychoactive substances before
- Drug or alcohol abuse
- Pregnant or lactating
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 |
|---|---|---|
| Intermittent theta burst stimulationIntermittent theta burst stimulation(iTBS) on the left DLPFC, the left DLPFC will be targeted utilizing the localite neuronavigation system. The stimulation intensity is set at 80% of resting motor threshold(RMT), and the other parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 600 pulses per session, total duration of 3 minutes and 20 seconds. | Device | iTBS stimulation |
| Sham stimulationThe same procedure will be performed in sham group including the RMT assessment and the neuronavigation system for target localization, but the sham coil will vertical to the brain surface and deliver a very slight magnetic field, which have the same appearance and sound, and provide the same tactile sensations as the active coils. | Device | Sham stimulation |
Primary outcome
Change in MCCB
Time frame: From baseline to 11days and the 30th day after the end of stimulation
The MATRICS Consensus Cognitive Battery,It can be used for cognitive assessment of schizophrenia, bipolar disorder and other neuropsychiatric diseases,The MCCB covers nine cognitive domains including attention, information processing speed, verbal learning and memory, visual learning and memory, spatial working memory, reasoning, problem solving, social cognition, executive function and fine motor. The working memory domain does not include verbal working memory because the Chinese language would not make feasible the inclusion of the LNS test.
Change in Positive and Negative Symptm Scale(PANSS) score
Time frame: From baseline to 11days and the 30th day after the end of stimulation
The scale to assess the severity of symptoms in schizophrenia.It is an evaluation scale of 30 disparate items scored from 1 to 7 for psychopathological symptoms observed in patients presenting psychotic syndromes, especially schizophrenic states.Three scores obtained with this scale are generally calculated for evaluating three dimensions of the syndrome: positive, negative and general psychopathology, as part of a categorial or dimensional perspective.The minimum value is 30 points, and the maximum value is 210 points.The higher the score, the more severe the relevant symptom is.
Change in Scale for Assessment of Positive Symptoms(SAPS) score
Time frame: From baseline to 11days and the 30th day after the end of stimulation
This scale is used to assess the severity of positive symptoms in schizophrenia. Evaluating four dimensions of the positive symptoms including hallucination, delusion, strange behavior and disorders of the positive thinking form.There are 34 items in the scale, which are divided into four subscales and graded on a six-point scale. The total score of the scale is the sum of 34 individual items, reflecting the severity of positive symptoms. The score range is 0-170, the higher the score, the more severe the symptoms are. The total score of the comprehensive evaluation is the sum of the individual score of the overall evaluation item of the four subscales, which also reflects the severity of positive symptoms, the score range is 0-20. The comprehensive evaluation score of the subscale is the single score of the overall evaluation item of the four subscales, specifically reflecting the severity of the four dimensions of the positive symptoms, the score range is 0-5.
Change in Scale for Assessment of Negative Symptoms(SANS) score
Time frame: From baseline to 11days and the 30th day after the end of stimulation
This scale is used to assess the severity of negative symptoms in schizophrenia. Evaluating five dimensions of the negative symptoms including apathy, poverty of thought, abulia, social withdrawal and disorders of attention.There are 24 items in the scale, which are divided into five subscales and graded on a six-point scale. The total score of the scale is the sum of 24 individual items, reflecting the severity of positive symptoms. The score range is 0-120, the higher the score, the more severe the negative symptoms are. The total score of the comprehensive evaluation is the sum of the individual score of the overall evaluation item of the five subscales, which also reflects the severity of negative symptoms, the score range is 0-25. The comprehensive evaluation score of the subscale is the single score of the overall evaluation item of the five subscales, specifically reflecting the severity of the five dimensions of the negative symptoms, the score range is 0-5.
The data of resting-state functional magnetic resonance imaging
Time frame: From baseline to 11days and the 30th day after the end of stimulation
All patients undergo head MRI scans in Philips Achieva 3.0 T scanner and SIEMENS Prisma 3.0 T scanner.
2 secondary outcomes
Change in Treatment Emergent Symptom Scale(TESS) score
Time frame: From baseline to 11days and the 30th day after the end of stimulation
The blood sample
Time frame: From baseline to 11days and the 30th day after the end of stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Renrong Wu, Prof principal investigator
The Second Xiangya Hospital of Central South University Psychiatry Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent theta burst stimulation in people with Schizophrenia, run by Central South 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 20 Aug 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 MCCB (time frame: From baseline to 11days and the 30th day after the end of stimulation). The study lists 5 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 20 Aug 2024.