SchizophreniaNCT03273439
A Study of rTMS for Cognitive Deficits in Chronic Patients With Schizophrenia
A study testing repetitive TMS in people with Schizophrenia, run by Suzhou Psychiatric Hospital.
Trial summary
In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- repetitive TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2012to 30 Jun 2015
- 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
- Right-handed;
- meeting the diagnosis of schizophrenia for at least 2 years;
- had been on anti-psychotic medications for more than 12 weeks;
- with unresolved negative symptoms (SANS>20).
Who cannot join
- with substance use disorders ;
- with cerebral pathologies (e.g. seizure, aneurysm, stroke), intra-cranial metals, pacemakers, severe cardiovascular diseases;
- receiving electroconvulsive therapy in the past 3 months.
About this study
Official title: A Randomized, Double-blind Study of Repetitive Transcranial Magnetic Stimulation for Cognitive Deficits in Chronic Patients With Schizophrenia in a Chinese Han Population
In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.
Read the detailed description
This is a randomized, sham-controlled, double-blinded trial. 47 patients diagnosed with schizophrenia on stable antipsychotic treatment were randomly assigned to active rTMS treatment group (n=25) or a sham rTMS treatment group (n=22). 25 patients in the active rTMS group received 10 Hz 110% rTMS, while 22 patients were subjected to sham rTMS, both being given 4-week treatment (5 days per week). Efficacy of negative symptom was assessed with the Scale for the Assessment of Negative Symptoms (SANS), the Positive and Negative symptom scale (PANSS) at baseline, the end of 4 weeks and 8 weeks. The cognitive function was assessed with CANTAB at baseline, the end of 4 weeks and 8 weeks .The side effects were assessed with Treatment Emergent Symptoms Scale at baseline and the end of 4 weeks.
- Conditions
- Schizophrenia
- Being tested
- repetitive TMS, Sham rTMS
- Keywords
- Repetitive transcranial magnetic stimulation, Negative symptoms, randomized controlled trial, Schizophrenia, cognition
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive TMSDevice
Also called rTMS
Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of motor threshold (MT) for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000).
Sham rTMSDevice
Sham rTMS, without stimulation
| Study group | Role | What they receive |
|---|---|---|
| repetitive TMS | Experimental | Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000). Receives: Device: repetitive TMS |
| Sham rTMS | Sham comparator | all procedures were identical except they were the unmagnetized steel cylinders, instead of cylindrical magnets, that were rotated. Participants were, therefore, unable to distinguish between active and sham rTMS. Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for the Assessment of Negative Symptoms (SANS)
clinical negative symptoms
Measured: 4 weeks
Secondary outcomes (2)
Positive and Negative symptom scale (PANSS)
Clinical symptoms
Measured: 4 weeks
CANTAB
cognition
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 posted6 Sep 2017
- Study start1 Jul 2012
- Primary completion1 Feb 2014
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Psychiatric Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhe Li, Suzhou Psychiatric Hospital
- Investigators
- Guangzhong Yin, MD, Study chair, Suzhou Guangji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273439
- Sponsor's protocol ID
- 46694276-1
- Other IDs
- Szzx201509
- Status last verified
- Sep 2017
- First submitted
- 15 Mar 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Lu X, Du S, Hu W, Xiao D, He B, Su C, Lin S, Zhan Q, Wu H, Li Z. Effects of varied rTMS frequencies on cognitive function in individuals with chronic schizophrenia: A double-blind randomized controlled trial. J Psychiatr Res. 2025 Sep;189:33-41. doi: 10.1016/j.jpsychires.2025.05.052. Epub 2025 May 23.
PubMed 40479952
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study of Repetitive Transcranial Magnetic Stimulation for Cognitive Deficits in Chronic Patients With Schizophrenia in a Chinese Han Population
- ClinicalTrials.gov ID
- NCT03273439
- Acronym / sponsor ID
- 46694276-1
- Conditions
- Schizophrenia
- Keywords
- Repetitive transcranial magnetic stimulation, Negative symptoms, randomized controlled trial, Schizophrenia, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Suzhou Psychiatric HospitalUniversity, hospital or other
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 1 Feb 2014 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 6 Sep 2017 (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.
In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.
Detailed description
This is a randomized, sham-controlled, double-blinded trial. 47 patients diagnosed with schizophrenia on stable antipsychotic treatment were randomly assigned to active rTMS treatment group (n=25) or a sham rTMS treatment group (n=22). 25 patients in the active rTMS group received 10 Hz 110% rTMS, while 22 patients were subjected to sham rTMS, both being given 4-week treatment (5 days per week). Efficacy of negative symptom was assessed with the Scale for the Assessment of Negative Symptoms (SANS), the Positive and Negative symptom scale (PANSS) at baseline, the end of 4 weeks and 8 weeks. The cognitive function was assessed with CANTAB at baseline, the end of 4 weeks and 8 weeks .The side effects were assessed with Treatment Emergent Symptoms Scale at baseline and the end of 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.
| Arm | Type | Receives |
|---|---|---|
| repetitive TMS | Experimental | Device: repetitive TMSPrior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000). |
| Sham rTMS | Sham comparator | Device: Sham rTMSall procedures were identical except they were the unmagnetized steel cylinders, instead of cylindrical magnets, that were rotated. Participants were, therefore, unable to distinguish between active and sham rTMS. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Right-handed;
- meeting the diagnosis of schizophrenia for at least 2 years;
- had been on anti-psychotic medications for more than 12 weeks;
- with unresolved negative symptoms (SANS>20).
Key exclusion criteria (3 listed)
- with substance use disorders ;
- with cerebral pathologies (e.g. seizure, aneurysm, stroke), intra-cranial metals, pacemakers, severe cardiovascular diseases;
- receiving electroconvulsive therapy in the past 3 months.
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 TMSAlso: rTMSPrior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of motor threshold (MT) for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000). | Device | repetitive TMS |
| Sham rTMSSham rTMS, without stimulation | Device | Sham rTMS |
Primary outcome
Scale for the Assessment of Negative Symptoms (SANS)
Time frame: 4 weeks
clinical negative symptoms
2 secondary outcomes
Positive and Negative symptom scale (PANSS)
Time frame: 4 weeks
CANTAB
Time frame: 4 weeks
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 6 Sep 2017.
- Derived from this study: PubMed 40479952Li J, Lu X, Du S, Hu W, Xiao D, He B, Su C, Lin S, Zhan Q, Wu H, Li Z. Effects of varied rTMS frequencies on cognitive function in individuals with chronic schizophrenia: A double-blind randomized controlled trial. J Psychiatr Res. 2025 Sep;189:33-41. doi: 10.1016/j.jpsychires.2025.05.052. Epub 2025 May 23.
- 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.
Guangzhong Yin, MD study chair
Suzhou Guangji Hospital
Questions about this trial
What is this clinical trial studying?
A study testing repetitive TMS in people with Schizophrenia, run by Suzhou Psychiatric Hospital.
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 3 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 6 Sep 2017. 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 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?
Scale for the Assessment of Negative Symptoms (SANS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03273439, which also lists 1 linked publication.
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 6 Sep 2017.