SchizophreniaNCT03736291
The Effect of Repetitive Transcranial Magnetic Stimulation in Schizophrenia
A study testing Repetitive transcranial magnetic stimulation in people with Schizophrenia, run by Shanghai Mental Health Center.
Trial summary
Repetitive Transcranial Magnetic Stimulation (rTMS) can modulate neuronal activity and has been shown to improve symptoms in patients with schizophrenia, but the underlying neural mechanism is unknown.This study hypothesized that repetitive transcranial magnetic stimulation of the cerebellar vermis can alter the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patient met the diagnostic criteria for schizophrenia in DSM-IV;
- 18-55 years old;
- Right handed;
- On stable doses of psychotropic medications.
Who cannot join
- DSM-IV diagnosis of other Axis I disorders；
- Contraindications to TMS or MRI；
- Patients receiving ECT (electro-convulsive therapy) in last 6months；
- Left-handedness。
About this study
Official title: The Effect of Repetitive Transcranial Magnetic Stimulation in Schizophrenia--A Randomized , Double-blind fMRI Study
Repetitive Transcranial Magnetic Stimulation (rTMS) can modulate neuronal activity and has been shown to improve symptoms in patients with schizophrenia, but the underlying neural mechanism is unknown.This study hypothesized that repetitive transcranial magnetic stimulation of the cerebellar vermis can alter the ciliary-related functional connections in schizophrenia, thereby improving negative symptoms, cognitive function, and emotional symptoms. Therefore, this study will firstly explore the difference in cerebellar functional connectivity between patients and healthy controls, and on this basis, patients undergo a resting state functional magnetic resonance scan before and after rTMS intervention in the cerebellar vermis, and observe the cerebellar function connection in the treatment. Before and after changes, analyze the relationship between these changes and clinical efficacy to explore the neural mechanisms of efficacy.
Read the detailed description
Repetitive Transcranial Magnetic Stimulation (rTMS) can modulate neuronal activity and has been shown to improve symptoms in patients with schizophrenia, but the underlying neural mechanism is unknown.This study hypothesized that repetitive transcranial magnetic stimulation of the cerebellar vermis can alter the ciliary-related functional connections in schizophrenia, thereby improving negative symptoms, cognitive function, and emotional symptoms. Therefore, this study will firstly explore the difference in cerebellar functional connectivity between patients and healthy controls, and on this basis, patients undergo a resting state functional magnetic resonance scan before and after rTMS intervention in the cerebellar vermis, and observe the cerebellar function connection in the treatment. Before and after changes, analyze the relationship between these changes and clinical efficacy to explore the neural mechanisms of efficacy.
- Aim of the study 1.1 Using resting state functional magnetic resonance imaging to observe the differences in cerebellar functional connections between schizophrenia patients and healthy controls, and to further understand the role of cerebellar abnormalities in the clinical symptoms of schizophrenia; 1.2 Provide evidence-based evidence and imaging evidence for the clinical efficacy of rTMS intervention in cerebellar palsy for patients with schizophrenia, and further understand the neural mechanism of efficacy.
- Content of the study 2.1 Based on previous studies, this study will use resting-state functional magnetic resonance imaging to observe abnormalities in behavioral and cerebellar neural networks in patients with schizophrenia compared with healthy controls, and to explore these abnormalities and schizophrenia. The relationship between clinical symptoms. 2.2 According to the research hypothesis, this study will perform a resting-state functional magnetic resonance scan of the patient before and after rTMS intervention in the cerebellar vermis. The functional connection analysis method is used to observe the changes of the cerebellar nerve network before and after treatment, and the imaging data and clinical evaluation. The data of the scale is combined to explore the neural mechanisms of treatment.
- Study design This study used resting-state functional magnetic resonance imaging to investigate the differences in cerebrospinal function connections between schizophrenia and healthy controls. Based on this, a randomized double-blind control design was used to study the repetitive transcranial magnetic stimulation of the cerebellar vermis for patients with schizophrenia. The clinical efficacy of the treatment and the neural mechanisms of the therapeutic effect. Inpatients with schizophrenia were admitted to the Shanghai Mental Health Center, and patients who met the criteria and successfully enrolled were randomly grouped (by random number table method), corresponding to the rTMS true stimulation group or the rTMS pseudo-stimulation group. Except for the rTMS operator, neither the patient nor the evaluator of the scale knew the patient's grouping.
- Conditions
- Schizophrenia
- Being tested
- Repetitive 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.
Repetitive transcranial magnetic stimulationDevice
Repetitive Transcranial Magnetic Stimulation (rTMS) is a widely used non-invasive neuromodulation technique that induces excitatory changes in the cerebral cortex stimulated by repeated pulsed magnetic fields on the scalp.
| Study group | Role | What they receive |
|---|---|---|
| active rTMS | Active comparator | The Active rTMS: The magnetic head uses the Magro X100's "8"-shaped coil, and the intervention site is the cerebellar vermis (1 cm below the occipital carina). The stimulation intensity is gradually increased by the 80%-100% exercise threshold according to the patient's tolerance. The total number of stimulation pulses per day is 600, the basic frequency is 5 Hz, and one short burst stimulus is given every 200 milliseconds. In each short array, three single pulses with a frequency of 50 Hz are buried, and every 10 short bursts are stimulated for 8 s. A total of 200 short bursts of stimulation. Intervention once a day, 5 times a week, intervention for 2 weeks, a total of 10 times. Receives: Device: Repetitive transcranial magnetic stimulation |
| sham rTMS | Sham comparator | The sham rTMS: The sham stimulation method was to invert the "8" shaped coil, which was 180° to the scalp, and other intervention parameters were consistent with the study group. Receives: Device: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
FCS
FCS (functional connectivity strength) value. The Pearson's correlation analysis was used to analyze the time series signals of the brain voxels, and the functional connection matrix model of each subject was established. The gray matter template is used to calculate the mean value of the functional connection between each brain voxel and other voxels, which is the FCS value of the voxel.
Measured: 4 weeks
Secondary outcomes (1)
PANSS
The clinical efficacy was determined according to the PANSS reduction rate. The PANSS reduction rate was calculated as the difference between the PANSS total score before and after treatment divided by the pre-treatment PANSS total score. The PANSS reduction rate was judged to be significant progress, progress, and ineffective by 50% to 100%, 20% to 49%, and 0 to 19%, respectively.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study startDec 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: There are two reasons why the study was stopped. One is that the machine to opreate MRI was damaged and we could not fix it. The second reason is the main reasearch fellow has graduated and there is no one else to conitune this project.
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.
- More trials run by Shanghai Mental Health CenterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Cai, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736291
- Sponsor's protocol ID
- JunCai
- Status last verified
- Sep 2021
- First submitted
- 6 Nov 2018
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Repetitive Transcranial Magnetic Stimulation in Schizophrenia--A Randomized , Double-blind fMRI Study
- ClinicalTrials.gov ID
- NCT03736291
- Acronym / sponsor ID
- JunCai
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There are two reasons why the study was stopped. One is that the machine to opreate MRI was damaged and we could not fix it. The second reason is the main reasearch fellow has graduated and there is no one else to conitune this project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 9 Nov 2018 (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.
Repetitive Transcranial Magnetic Stimulation (rTMS) can modulate neuronal activity and has been shown to improve symptoms in patients with schizophrenia, but the underlying neural mechanism is unknown.This study hypothesized that repetitive transcranial magnetic stimulation of the cerebellar vermis can alter the ciliary-related functional connections in schizophrenia, thereby improving negative symptoms, cognitive function, and emotional symptoms. Therefore, this study will firstly explore the difference in cerebellar functional connectivity between patients and healthy controls, and on this basis, patients undergo a resting state functional magnetic resonance scan before and after rTMS intervention in the cerebellar vermis, and observe the cerebellar function connection in the treatment. Before and after changes, analyze the relationship between these changes and clinical efficacy to explore the neural mechanisms of efficacy.
Detailed description
Repetitive Transcranial Magnetic Stimulation (rTMS) can modulate neuronal activity and has been shown to improve symptoms in patients with schizophrenia, but the underlying neural mechanism is unknown.This study hypothesized that repetitive transcranial magnetic stimulation of the cerebellar vermis can alter the ciliary-related functional connections in schizophrenia, thereby improving negative symptoms, cognitive function, and emotional symptoms. Therefore, this study will firstly explore the difference in cerebellar functional connectivity between patients and healthy controls, and on this basis, patients undergo a resting state functional magnetic resonance scan before and after rTMS intervention in the cerebellar vermis, and observe the cerebellar function connection in the treatment. Before and after changes, analyze the relationship between these changes and clinical efficacy to explore the neural mechanisms of efficacy.
- Aim of the study 1.1 Using resting state functional magnetic resonance imaging to observe the differences in cerebellar functional connections between schizophrenia patients and healthy controls, and to further understand the role of cerebellar abnormalities in the clinical symptoms of schizophrenia; 1.2 Provide evidence-based evidence and imaging evidence for the clinical efficacy of rTMS intervention in cerebellar palsy for patients with schizophrenia, and further understand the neural mechanism of efficacy.
- Content of the study 2.1 Based on previous studies, this study will use resting-state functional magnetic resonance imaging to observe abnormalities in behavioral and cerebellar neural networks in patients with schizophrenia compared with healthy controls, and to explore these abnormalities and schizophrenia. The relationship between clinical symptoms. 2.2 According to the research hypothesis, this study will perform a resting-state functional magnetic resonance scan of the patient before and after rTMS intervention in the cerebellar vermis. The functional connection analysis method is used to observe the changes of the cerebellar nerve network before and after treatment, and the imaging data and clinical evaluation. The data of the scale is combined to explore the neural mechanisms of treatment.
- Study design This study used resting-state functional magnetic resonance imaging to investigate the differences in cerebrospinal function connections between schizophrenia and healthy controls. Based on this, a randomized double-blind control design was used to study the repetitive transcranial magnetic stimulation of the cerebellar vermis for patients with schizophrenia. The clinical efficacy of the treatment and the neural mechanisms of the therapeutic effect. Inpatients with schizophrenia were admitted to the Shanghai Mental Health Center, and patients who met the criteria and successfully enrolled were randomly grouped (by random number table method), corresponding to the rTMS true stimulation group or the rTMS pseudo-stimulation group. Except for the rTMS operator, neither the patient nor the evaluator of the scale knew the patient's grouping.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active rTMS | Active comparator | Device: Repetitive transcranial magnetic stimulationThe Active rTMS: The magnetic head uses the Magro X100's "8"-shaped coil, and the intervention site is the cerebellar vermis (1 cm below the occipital carina). The stimulation intensity is gradually increased by the 80%-100% exercise threshold according to the patient's tolerance. The total number of stimulation pulses per day is 600, the basic frequency is 5 Hz, and one short burst stimulus is given every 200 milliseconds. In each short array, three single pulses with a frequency of 50 Hz are buried, and every 10 short bursts are stimulated for 8 s. A total of 200 short bursts of stimulation. Intervention once a day, 5 times a week, intervention for 2 weeks, a total of 10 times. |
| sham rTMS | Sham comparator | Device: Repetitive transcranial magnetic stimulationThe sham rTMS: The sham stimulation method was to invert the "8" shaped coil, which was 180° to the scalp, and other intervention parameters were consistent with the study group. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The patient met the diagnostic criteria for schizophrenia in DSM-IV;
- 18-55 years old;
- Right handed;
- On stable doses of psychotropic medications.
Key exclusion criteria (4 listed)
- DSM-IV diagnosis of other Axis I disorders；
- Contraindications to TMS or MRI；
- Patients receiving ECT (electro-convulsive therapy) in last 6months；
- Left-handedness。
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 stimulationRepetitive Transcranial Magnetic Stimulation (rTMS) is a widely used non-invasive neuromodulation technique that induces excitatory changes in the cerebral cortex stimulated by repeated pulsed magnetic fields on the scalp. | Device | active rTMS, sham rTMS |
Primary outcome
FCS
Time frame: 4 weeks
FCS (functional connectivity strength) value. The Pearson's correlation analysis was used to analyze the time series signals of the brain voxels, and the functional connection matrix model of each subject was established. The gray matter template is used to calculate the mean value of the functional connection between each brain voxel and other voxels, which is the FCS value of the voxel.
1 secondary outcome
PANSS
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- 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.
Jun Cai study director
Shanghai Mental Health Center
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Schizophrenia, run by Shanghai Mental Health Center.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
FCS (time frame: 4 weeks). 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 27 Sep 2021.