SchizophreniaNCT02863094
Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Schizophrenia Patients With Auditory Hallucinations
A study testing transcranial magnetic stimulation in people with Schizophrenia and Transcranial Magnetic Stimulation, run by Anhui Medical University at 1 site in China.
Trial summary
To investigate the treatment effect of continuous transcranial magnetic stimulation on schizophrenia patients with auditory hallucinations, and the underlying neural mechanism by functional MRI Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging
- 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
- May 2016to Aug 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 50 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 reported auditory hallucinations at least 5 times per day based on pre-enrollment assessments using a written log or hand-held counter.
- 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
Show all 11Show fewer
- 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 > 7
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the treatment effect of continuous transcranial magnetic stimulation on schizophrenia patients with auditory hallucinations, and the underlying neural mechanism by functional MRI
Read the detailed description
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS) treatment. Patients were randomly allocated to rTMS group and the sham group by random number. 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 rTMS administrators had access to the randomization list; they had minimal contact with the patients, and no role in assessing AVH and other measures. Each patient would be treated for continuous 15 days by rTMS
Before the rTMS treatment, the Auditory Hallucination Rating Scale, Psychotic Symptom Rating Scale, and the Positive and Negative Syndrome Scale were obtained by a trained investigator to assess baseline severity of auditory verbal hallucination (AVH) and other symptoms. 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.
After the last treatment, the Auditory Hallucination Rating Scale, Psychotic Symptom Rating Scale, and 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 15 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multimodalities, and EEG record.
A month after the last treatment, participants were interviewed to obtain the Auditory Hallucination Rating Scale, Psychotic Symptom Rating Scale, the Positive, and Negative Syndrome Scale. 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
- Keywords
- schizophrenia, auditory hallucinations, functional magnetic resonance imaging, transcranial magnetic stimulation
- Medical subject headings
- Schizophrenia, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Real Stimulation | Active comparator | The continuous theta burst stimulation (cTBS) protocol lasted 40 s and consisted of burst of 3 pulses delivered at 50 Hz, with bursts being repeated every 200 ms (at 5 Hz) for a total of 600 pulses. In the cTBS session, this 40s protocol was repeated for three times (1800 pulses in total) separated by two 15 min breaks (controlled by a stopwatch). MRI dataset should be acquired before the first cTBS session and after the last cTBS session. Receives: Device: transcranial magnetic stimulation |
| Placebo Stimulation | Sham comparator | The procedure of this protocol was performed by a placebo coil. Each session lasted 40 s and consisted of burst of 3 pulses delivered at 50 Hz, with bursts being repeated every 200 ms (at 5 Hz) for a total of 600 pulses. No actual magnetic stimulation was applied on the head of the volunteers. MRI dataset should be acquired before the first sham TBS session and after the last sham TBS session. Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom improvement assessed by Auditory Hallucination Rating Scale
Measured: up to 2 months
Secondary outcomes (4)
functional connectivity of the temporal parietal junction assessed by functional MRI
Functional MRI measures: the functional connectivity between stimulated target and the whole brain areas
Measured: up to 2 months
Global network properties assessed through Graph Theory
Measured: up to 2 months
Symptom improvement assessed by Positive and Negative Syndrome Scale
Measured: up to 2 months
Global structural connectivity assessed by diffusion weighted image
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2021
- Study completionAug 2021
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
- Investigators
- Kai Wang, MD, Principal investigator, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863094
- Sponsor's protocol ID
- NSFC-81171273-01
- Status last verified
- Oct 2021
- First submitted
- 7 Jul 2016
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hua Q, Wang L, He K, Sun J, Xu W, Zhang L, Tian Y, Wang K, Ji GJ. Repetitive Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations in Schizophrenia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2444215. doi: 10.1001/jamanetworkopen.2024.44215.
PubMed 39527055
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Schizophrenia Patients With Auditory Hallucinations
- ClinicalTrials.gov ID
- NCT02863094
- Acronym / sponsor ID
- NSFC-81171273-01
- Keywords
- schizophrenia, auditory hallucinations, functional magnetic resonance imaging, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Aug 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 11 Aug 2016 (estimated)
- 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 continuous transcranial magnetic stimulation on schizophrenia patients with auditory hallucinations, and the underlying neural mechanism by functional MRI
Detailed description
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS) treatment. Patients were randomly allocated to rTMS group and the sham group by random number. 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 rTMS administrators had access to the randomization list; they had minimal contact with the patients, and no role in assessing AVH and other measures. Each patient would be treated for continuous 15 days by rTMS
Before the rTMS treatment, the Auditory Hallucination Rating Scale, Psychotic Symptom Rating Scale, and the Positive and Negative Syndrome Scale were obtained by a trained investigator to assess baseline severity of auditory verbal hallucination (AVH) and other symptoms. 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.
After the last treatment, the Auditory Hallucination Rating Scale, Psychotic Symptom Rating Scale, and 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 15 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multimodalities, and EEG record.
A month after the last treatment, participants were interviewed to obtain the Auditory Hallucination Rating Scale, Psychotic Symptom Rating Scale, the Positive, and Negative Syndrome Scale. 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 stimulationThe continuous theta burst stimulation (cTBS) protocol lasted 40 s and consisted of burst of 3 pulses delivered at 50 Hz, with bursts being repeated every 200 ms (at 5 Hz) for a total of 600 pulses. In the cTBS session, this 40s protocol was repeated for three times (1800 pulses in total) separated by two 15 min breaks (controlled by a stopwatch). MRI dataset should be acquired before the first cTBS session and after the last cTBS session. |
| Placebo Stimulation | Sham comparator | Device: transcranial magnetic stimulationThe procedure of this protocol was performed by a placebo coil. Each session lasted 40 s and consisted of burst of 3 pulses delivered at 50 Hz, with bursts being repeated every 200 ms (at 5 Hz) for a total of 600 pulses. No actual magnetic stimulation was applied on the head of the volunteers. MRI dataset should be acquired before the first sham TBS session and after the last sham TBS session. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 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 reported auditory hallucinations at least 5 times per day based on pre-enrollment assessments using a written log or hand-held counter.
- 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 (11 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,
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 stimulation | Device | Placebo Stimulation, Real Stimulation |
Primary outcome
Symptom improvement assessed by Auditory Hallucination Rating Scale
Time frame: up to 2 months
4 secondary outcomes
functional connectivity of the temporal parietal junction assessed by functional MRI
Time frame: up to 2 months
Global network properties assessed through Graph Theory
Time frame: up to 2 months
Symptom improvement assessed by Positive and Negative Syndrome Scale
Time frame: up to 2 months
Global structural connectivity assessed by diffusion weighted image
Time frame: up to 2 months
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 12 Oct 2021.
- Derived from this study: PubMed 39527055Hua Q, Wang L, He K, Sun J, Xu W, Zhang L, Tian Y, Wang K, Ji GJ. Repetitive Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations in Schizophrenia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2444215. doi: 10.1001/jamanetworkopen.2024.44215.
- 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.
Kai Wang, MD principal investigator
Anhui Medical University
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 Transcranial Magnetic Stimulation, run by Anhui Medical 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 4 inclusion and 11 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 12 Oct 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?
Symptom improvement assessed by Auditory Hallucination Rating Scale (time frame: up to 2 months). 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 NCT02863094, 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 12 Oct 2021.