SchizophreniaNCT03868358
Effect of Intermittent Theta Burst Stimulation (iTBS) for Alleviating Symptoms of Schizophrenia Patients
A study testing transcranial magnetic stimulation in people with Schizophrenia and Functional Magnetic Resonance Imaging, run by WANG KAI at 1 site in China.
Trial summary
To investigate the treatment effect of intermittent theta-burst transcranial magnetic stimulation on symptomatic relief of schizophrenia patients, and the underlying neural mechanism by functional MRI and the resting electroencephalogram Read more about this study
- Who is it for?
- Ages 18 to 52 years
- Conditions the study is for
- Schizophrenia, Functional Magnetic Resonance Imaging, Transcranial Magnetic Stimulation
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2017to 30 Mar 2021
- 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 52 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients met diagnostic criteria for schizophrenia or schizoaffective disorder using the Structural Clinical Interview for Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-IV (SCID, Version 2.0).
- Patients remain their psychotropic medication at steady dosages for at least 4 weeks prior to study entry and for the duration of the trial.
- Verbal intelligence quotient > 85 as measured by using a Chinese version of the National Adult Reading Test.
Who cannot join
- History of significant head trauma or neurological disorders
- Alcohol or drug abuse Focal brain lesions on T1- or T2-weighted fluid-attenuated inversion-recovery magnetic resonance images
- a prior history of a seizure not induced by drug withdrawal,first degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease, such as thyroid disease, significant unstable medical condition, recent aggression or other forms of behavioral dyscontrol
- left-handedness, pregnancy
- estimated intelligence quotient<80
- current alcohol or drug abuse
- inability to provide informed consent.
- Hamilton Anxiety Rating Scale or the Hamilton Depression Rating Scale score > 14
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the treatment effect of intermittent theta-burst transcranial magnetic stimulation on symptomatic relief of schizophrenia patients, and the underlying neural mechanism by functional MRI and the resting electroencephalogram
Read the detailed description
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after intermittent theta-burst transcranial magnetic stimulation (iTBS) treatment. Patients were randomly allocated to iTBS group and the sham group by coin toss. There are about 30 patients in each group.The decision to enroll a patient was always made prior to randomization. Patients were studied using a double-blind design. Study participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only iTBS administrators had access to the randomization list; they had minimal contact with the patients, and no role in assessing the Positive and Negative Syndrome Scale (PANSS). Each patient would be treated for continuous 14 days by iTBS.Before the iTBS treatment, PANSS and Clinical Global Impression-severity of illness (CGI-SI) at baseline were obtained by a trained investigator to assess baseline severity of their symptoms. Scale for the Assessment of Negative Symptoms (SANS) and Scale for Assessment of Positive Symptoms (SAPS) were respectively supplemented to evaluate the severity of symptoms in different dimensions,.The patients had receiving a battery measure of neuropsychological tests (standardized tests to investigate their cognitive problems, anxiety and depressive symptoms in daily life), magnetic resonance imaging scan in multimodalities, electroencephalography (EEG), event-related potentials during stop signal test and Iowa-gambling test record. Other behavioral tests including intertemporal decision,spatial n-back test record.
After the last treatment, the Positive and Negative Syndrome Scale were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multimodalities, and EEG record.Clinical Global Impression-global improvement (CGI-GI), Clinical Global Impression-efficacy index (CGI-EI) were evaluated at the end of treatment.
40-60 days after the last treatment, participants were interviewed to obtain the Positive and Negative Syndrome Scale,SAPS,SANS and HAMA,HAMD. They were instructed to focus their answers on the past week. Additionally, they were also asked to assess the battery of neuropsychological tests, and have magnetic resonance imaging scan in multimodalities, and EEG record. Afterwards, they were unblinded by the study coordinator.
- Being tested
- transcranial magnetic stimulation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
The stimulations were performed by MagStim Rapid2. Participants in active comparator will receive active transcranial magnetic stimulation(Real Stimulation) daily for two weeks.
Participants in sham comparator will receive no stimulation(Sham Stimulation) daily for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Real Stimulation | Active comparator | Real Stimulation: active transcranial magnetic stimulation(Intermittent Theta Burst Stimulation).Participants will receive active TMS once daily for two weeks Receives: Device: transcranial magnetic stimulation |
| Sham Stimulation | Placebo comparator | Sham Stimulation:no stimulation.Participants will receive sham TMS once daily for two weeks Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive And Negative Syndrome Scale(PANSS)
The improvment in PANSS scores will constitute the major research outcome measure used to assess response to rTMS,reflecting the symptom improvment in patients
Measured: Baseline and 2 weeks post-treatment,and follow-up
Secondary outcomes (7)
Scale for the Assessment of Positive Symptoms (SAPS)
The improvment in SAPS scores will constitute the major research outcome, and specifically reflect the degree of improvement in patients' positive symptoms
Measured: Baseline and 2 weeks post-treatment and follow-up
Scale for the Assessment of Negative Symptoms (SANS)
The improvment in SANS scores will constitute the major research outcome, and specifically reflect the degree of improvement in patients' negative symptoms
Measured: Baseline and 2 weeks post-treatment and follow-up
Functional connectivity change of transcranial magnetic stimulation(iTBS and sham)
Functional MRI measures: the functional connectivity between stimulated target and the whole brain areas
Measured: Baseline and 2 weeks post-treatment
EEG change of transcranial magnetic stimulation(iTBS and sham)
EEG measures: brain areas wave change of stimulation(iTBS and sham)
Measured: Baseline and 2 weeks post-treatment
Intertemporal decision test
Intertemporal decision test is associated with the function of left dorsolateral prefrontal cortex
Measured: Baseline and 2 weeks post-treatment
Spatial n-back test
Spatial n-back test will reflect the prefrontal function
Measured: Baseline and 2 weeks post-treatment
Multidimensional Empathy Test
Multidimensional empathy Test is associated with the function of left dorsolateral prefrontal cortex
Measured: Baseline and 2 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start21 May 2017
- Primary completion9 Jul 2020
- Study completion30 Mar 2021
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- WANG KAI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868358
- Sponsor's protocol ID
- ahmu-sjnk-scz
- Status last verified
- Apr 2021
- First submitted
- 3 Mar 2019
- Last updated
- 15 Apr 2021
- 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 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Theta Burst Stimulation (iTBS) for Alleviating Symptoms of Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT03868358
- Acronym / sponsor ID
- ahmu-sjnk-scz
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- WANG KAIUniversity, hospital or other
- Study start
- 21 May 2017 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 11 Mar 2019 (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.
To investigate the treatment effect of intermittent theta-burst transcranial magnetic stimulation on symptomatic relief of schizophrenia patients, and the underlying neural mechanism by functional MRI and the resting electroencephalogram
Detailed description
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after intermittent theta-burst transcranial magnetic stimulation (iTBS) treatment. Patients were randomly allocated to iTBS group and the sham group by coin toss. There are about 30 patients in each group.The decision to enroll a patient was always made prior to randomization. Patients were studied using a double-blind design. Study participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only iTBS administrators had access to the randomization list; they had minimal contact with the patients, and no role in assessing the Positive and Negative Syndrome Scale (PANSS). Each patient would be treated for continuous 14 days by iTBS.Before the iTBS treatment, PANSS and Clinical Global Impression-severity of illness (CGI-SI) at baseline were obtained by a trained investigator to assess baseline severity of their symptoms. Scale for the Assessment of Negative Symptoms (SANS) and Scale for Assessment of Positive Symptoms (SAPS) were respectively supplemented to evaluate the severity of symptoms in different dimensions,.The patients had receiving a battery measure of neuropsychological tests (standardized tests to investigate their cognitive problems, anxiety and depressive symptoms in daily life), magnetic resonance imaging scan in multimodalities, electroencephalography (EEG), event-related potentials during stop signal test and Iowa-gambling test record. Other behavioral tests including intertemporal decision,spatial n-back test record.
After the last treatment, the Positive and Negative Syndrome Scale were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multimodalities, and EEG record.Clinical Global Impression-global improvement (CGI-GI), Clinical Global Impression-efficacy index (CGI-EI) were evaluated at the end of treatment.
40-60 days after the last treatment, participants were interviewed to obtain the Positive and Negative Syndrome Scale,SAPS,SANS and HAMA,HAMD. They were instructed to focus their answers on the past week. Additionally, they were also asked to assess the battery of neuropsychological tests, and have magnetic resonance imaging scan in multimodalities, and EEG record. Afterwards, they were unblinded by the study coordinator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Stimulation | Active comparator | Device: transcranial magnetic stimulationReal Stimulation: active transcranial magnetic stimulation(Intermittent Theta Burst Stimulation).Participants will receive active TMS once daily for two weeks |
| Sham Stimulation | Placebo comparator | Device: transcranial magnetic stimulationSham Stimulation:no stimulation.Participants will receive sham TMS once daily for two weeks |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients met diagnostic criteria for schizophrenia or schizoaffective disorder using the Structural Clinical Interview for Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-IV (SCID, Version 2.0).
- Patients remain their psychotropic medication at steady dosages for at least 4 weeks prior to study entry and for the duration of the trial.
- Verbal intelligence quotient > 85 as measured by using a Chinese version of the National Adult Reading Test.
Key exclusion criteria (8 listed)
- History of significant head trauma or neurological disorders
- Alcohol or drug abuse Focal brain lesions on T1- or T2-weighted fluid-attenuated inversion-recovery magnetic resonance images
- a prior history of a seizure not induced by drug withdrawal,first degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease, such as thyroid disease, significant unstable medical condition, recent aggression or other forms of behavioral dyscontrol
- left-handedness, pregnancy
- estimated intelligence quotient<80
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 |
|---|---|---|
| transcranial magnetic stimulationThe stimulations were performed by MagStim Rapid2. Participants in active comparator will receive active transcranial magnetic stimulation(Real Stimulation) daily for two weeks. Participants in sham comparator will receive no stimulation(Sham Stimulation) daily for two weeks | Device | Real Stimulation, Sham Stimulation |
Primary outcome
Positive And Negative Syndrome Scale(PANSS)
Time frame: Baseline and 2 weeks post-treatment,and follow-up
The improvment in PANSS scores will constitute the major research outcome measure used to assess response to rTMS,reflecting the symptom improvment in patients
7 secondary outcomes
Scale for the Assessment of Positive Symptoms (SAPS)
Time frame: Baseline and 2 weeks post-treatment and follow-up
Scale for the Assessment of Negative Symptoms (SANS)
Time frame: Baseline and 2 weeks post-treatment and follow-up
Functional connectivity change of transcranial magnetic stimulation(iTBS and sham)
Time frame: Baseline and 2 weeks post-treatment
EEG change of transcranial magnetic stimulation(iTBS and sham)
Time frame: Baseline and 2 weeks post-treatment
Intertemporal decision test
Time frame: Baseline and 2 weeks post-treatment
Spatial n-back test
Time frame: Baseline and 2 weeks post-treatment
Multidimensional Empathy Test
Time frame: Baseline and 2 weeks post-treatment
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 15 Apr 2021.
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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 transcranial magnetic stimulation in people with Schizophrenia and Functional Magnetic Resonance Imaging, run by WANG KAI 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 3 inclusion and 8 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 15 Apr 2021. 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?
Positive And Negative Syndrome Scale(PANSS) (time frame: Baseline and 2 weeks post-treatment,and follow-up). 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 15 Apr 2021.