Schizophrenia; PsychosisNCT04853485

Repetitive Transcranial Magnetic Stimulation in Early Psychosis and The Functional Connectivity Biotypes

A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Schizophrenia; Psychosis and First Episode Psychosis, run by Shanghai Jiao Tong University School of Medicine at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The present study plans to explore different cortical targets of repetitive transcranial magnetic stimulation (rTMS) for populations at the early phase of psychosis, including those at clinical high risk of psychosis and in the first episode of psychosis. Read more about this study

Who is it for?: Ages 14 to 45 years
Conditions the study is for: Schizophrenia; Psychosis, First Episode Psychosis, Clinical High Risk
What is being tested?: repetitive transcranial magnetic stimulation (rTMS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: 6 sitesChina
Study dates: 1 Aug 2020to 31 Dec 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 14 to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Meeting the syndrome of clinical high risk of psychosis, identified by a face-to-face interview using the Chinese version of Structured Interview for Prodromal Syndromes / Scale of Prodromal Symptoms (SIPS/SOPS);
Given the written consent for participation.
Age between 14-45 years old;
IQ>69;
PANSS total scores >= 55 or BVMT-R score <= 26;
Meeting the DSM-V diagnostic criteria for schizophrenia spectrum disorders;

Show all 12Show fewer

Given the written consent for participation.
Age between 14-45 years old;
IQ>69;
during the first episode without a full remission;
PANSS total scores >= 55 or BVMT-R score <= 26;
within receiving rTMS, patients can receive second-generation antipsychotics except clozapine with stable dosages

Who cannot join

any contraindication to TMS treatment or magnetic resonance imaging (MRI)
substance or alcohol abuse within recent three months
any sensorimotor disorder (e.g., hearing disorder, lose one's sight), or any neurological disease (brain injury, epilepsy ) or any other physical disease which may lead to psychotic symptoms.
For subjects with first-episode schizophrenia
any contraindication to TMS treatment or magnetic resonance imaging (MRI)
substance or alcohol abuse within recent three months
any sensorimotor disorder (e.g., hearing disorder, lose one's sight), or any neurological disease (brain injury, epilepsy) or any other physical disease which may lead to psychotic symptoms.

Trial locations and contacts

6 sites in 1 country.

Jijun Wang, M.D, Ph.D contact

86-21-34773065

jijunwang27@163.com

City, postcode or hospital

Sites recruiting now only

6 sites in 1 country

China6 sites, 6 recruiting

The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Liping Cao
Not yet recruiting
Nantong Fourth People's Hospital & Nantong Brain Hospital
Nantong, Jiangsu, 226000
Xing Chen
Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Jijun Wang, MD, PhD, jijunwang27@163.com
Recruiting
Shenzhen Kangning Hospital
Shenzhen
Lingyun Zeng
Recruiting
Suzhou Guangji Hospital
Suzhou, Jiangsu
Li Hui, PhD
Recruiting
Tianjin Anding Hospital
Tianjin
Bin Zhang
Recruiting

Other trials in China

About this study

Official title: Repetitive Transcranial Magnetic Stimulation in Subjects With Early Psychosis and The Functional Connectivity Biotypes

Read the detailed description

Schizophrenia is a life long illness, the management of its early stage is the key in its long term outcomes. The early stage of schizophrenia includes the prodromal and first episode, during which the patients present psychotic symptoms (positive symptoms, negative symptoms) and cognition deficits. Antipsychotics are often prescribed to treat these symptoms, but more than one third patients do not respond well. Regarding cognition deficits, for example, while the visual spatial learning evaluated using Brief Visuospatial Memory Test-Revised (BVMT-R) of The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) may play an important role in the conversion of psychosis in the prodromal phase, there is still no corresponding intervention.

Repetitive transcranial magnetic stimulation (rTMS) is a new non-invasive brain stimulation. In previous studies, its applications mainly focus on negative symptoms and demonstrate promising findings. However, its efficacy has much needing improvement, urgently needing target optimizing and precision, especially according to the prominent complaints of patients. To solve this issue, the present project proposed to make efforts in 3 aspects: to recruit patients in early phase of illness, to administer rTMS of different protocols according to the symptoms and cognition, and to associate the biotypes of functional connectivity with rTMS's efficacy. All subjects will receive MRI scan before rTMS intervention in the present study. The clinical efficacy of rTMS of the present protocol will be applied to validate the biotypes of functional connectivity in early psychosis. The biotypes will be determined using an existing independent dataset, which include 650 available cases of resting MRI (including 400 patients in prodromal phase, 100 patients with first episode and 150 controls).

Individual rTMS target will be optimized basing individual neuroimaging navigation. In the present protocol, we will recruit 300 new cases and perform a multicenter and randomized clinical trial to test the efficacy of our optimized rTMS protocols. All patients will be stratified according to their negative symptoms, positive symptom and cognition, and this will be determined by a panel of psychiatrists and rTMS therapists. It is estimated that about 100 cases in each of three subgroups. Subgroup 1 is characterized by prominent negative symptoms and will receives rTMS over cerebellum and right dorsolateral prefrontal cortex. Subgroup 2 is characterized by prominent cognition deficits and will receive rTMS over left inferior parietal lobule, navigated by individual MRI and functional connectivity map with left hippocampus. Subgroup 3 is characterized by positive symptoms and will receive deep rTMS over ACC using H7 coil. The present project, if being performed successfully, will promote the non-invasive physical therapy in psychiatry to a significantly higher level.

Conditions: Schizophrenia; Psychosis, First Episode Psychosis, Clinical High Risk
Being tested: repetitive transcranial magnetic stimulation (rTMS)
Keywords: schizophrenia, prodromal phase, biotypes, target optimizing, precision calculation
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

repetitive transcranial magnetic stimulation (rTMS)Device
All subjects with early psychosis will be divided into three subgroups determined by their psychotic symptoms and cognition. There are three rTMS strategies: (1) For subgroup 1, characterized by negative symptoms, iTBS over cerebellum and 1 Hz over right DLPFC; (2) For subgroup 2, characterized by cognition deficits, 20 Hz over the left inferior parietal cortex; (3) For subgroup 3, characterized by positive symptoms: 10 Hz over ACC. Ten to twenty sessions of rTMS will be delivered to each patients during the intervention period.

Study groups in NCT04853485
Study group	Role	What they receive
Active TMS targeting both cerebellum and right dorsolateral prefrontal cortex.	Active comparator	Subjects identified as with prominent negative symptoms will be randomized into active group, who will receive active rTMS over cerebellum and right dorsolateral prefrontal cortex navigated by individual MRI. Receives: Device: repetitive transcranial magnetic stimulation (rTMS)
Sham TMS targeting both cerebellum and right dorsolateral prefrontal cortex	Sham comparator	Subjects identified as with prominent negative symptoms will be randomized into sham group, who will receive sham rTMS over cerebellum and right dorsolateral prefrontal cortex navigated by individual MRI. Receives: Device: repetitive transcranial magnetic stimulation (rTMS)
Active TMS targeting left inferior parietal lobule	Active comparator	Subjects identified with prominent cognition deficits wil be randomized into active group, who will receive active rTMS over left inferior parietal lobule, navigated by individual MRI and functional connectivity map with left hippocampus. Receives: Device: repetitive transcranial magnetic stimulation (rTMS)
Sham TMS targeting left inferior parietal lobule	Placebo comparator	Subjects identified with prominent cognition deficits wil be randomized into sham group, who will receive sham rTMS over left inferior parietal lobule, navigated by individual MRI and functional connectivity map with left hippocampus. Receives: Device: repetitive transcranial magnetic stimulation (rTMS)
Active deep TMS using Brainways H7 coil targeting ACC	Active comparator	Subjects identified as with positive symptoms will be randomized into active group, who will receive active deep rTMS over ACC using H7 coil. Receives: Device: repetitive transcranial magnetic stimulation (rTMS)
Sham deep TMS using Brainways H7 coil targeting ACC	Placebo comparator	Subjects identified with positive symptoms will be randomized into sham group, who will receive sham deep rTMS over ACC using H7 coil. Receives: Device: repetitive transcranial magnetic stimulation (rTMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Response rate (the number of non-responders) for subgroup 1 and subgroup 3
Response or responder will be determined by the reduction of PANSS total scores >= 25%
Measured: Within 24 hours after the rTMS intervention
Improvement on cognition for subgroup 2
Change in BVMT-R score as measured by MCCB
Measured: Within 24 hours after the rTMS intervention

Secondary outcomes (9)

Improvement of psychotic symptoms
The changes of PANSS scores and sub-scale scores
Measured: Within 24 hours after the rTMS intervention
Improvement of prodromal symptoms
The changes of SOPS scores and sub-scale scores
Measured: Within 24 hours after the rTMS intervention
Improvement of cognitive function
The changes of all cognitive domains assessed by MCCB
Measured: Within 24 hours after the rTMS intervention
Improvement of global functioning
The GAF changes
Measured: Within 24 hours after the rTMS intervention
Functional connectivity
changes of whole-brain functional connectivity patterns
Measured: Within 1week after the rTMS intervention
side effect and safety
the frequency and severity of side effects
Measured: during and after rTMS intervention
clinical outcome
remission, non-remission or relapse
Measured: 1 year
The accuracy of prediction with functional connectivity biotypes at baseline
The association of clinical outcomes after rTMS intervention with functional connectivity biotypes at baseline
Measured: 1 year
change in individualized psychosis risk score
For subjects at clinical high risk of psychosis, individualized psychosis risk score will be calculated using clinical symptoms and cognition, which indicate the psychosis risk in the future.
Measured: Within 24 hours after the rTMS intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202031 Dec 2024

First posted21 Apr 2021
Study start1 Aug 2020
Primary completion31 Dec 2023 (estimated)
Study completion31 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
More trials run by Shanghai Jiao Tong University School of MedicineThe 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: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04853485
Sponsor's protocol ID: CRC2018ZD01
Status last verified: Dec 2023
First submitted: 31 Mar 2021
Last updated: 29 Dec 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cui H, Giuliano AJ, Zhang T, Xu L, Wei Y, Tang Y, Qian Z, Stone LM, Li H, Whitfield-Gabrieli S, Niznikiewicz M, Keshavan MS, Shenton ME, Wang J, Stone WS. Cognitive dysfunction in a psychotropic medication-naive, clinical high-risk sample from the ShangHai-At-Risk-for-Psychosis (SHARP) study: Associations with clinical outcomes. Schizophr Res. 2020 Dec;226:138-146. doi: 10.1016/j.schres.2020.06.018. Epub 2020 Jul 18.
PubMed 32694037
Wang J, Zhou Y, Gan H, Pang J, Li H, Wang J, Li C. Efficacy Towards Negative Symptoms and Safety of Repetitive Transcranial Magnetic Stimulation Treatment for Patients with Schizophrenia: A Systematic Review. Shanghai Arch Psychiatry. 2017 Apr 25;29(2):61-76. doi: 10.11919/j.issn.1002-0829.217024.
PubMed 28765677
Zhuo K, Tang Y, Song Z, Wang Y, Wang J, Qian Z, Li H, Xiang Q, Chen T, Yang Z, Xu Y, Fan X, Wang J, Liu D. Repetitive transcranial magnetic stimulation as an adjunctive treatment for negative symptoms and cognitive impairment in patients with schizophrenia: a randomized, double-blind, sham-controlled trial. Neuropsychiatr Dis Treat. 2019 May 8;15:1141-1150. doi: 10.2147/NDT.S196086. eCollection 2019.
PubMed 31190822
Brady RO Jr, Gonsalvez I, Lee I, Ongur D, Seidman LJ, Schmahmann JD, Eack SM, Keshavan MS, Pascual-Leone A, Halko MA. Cerebellar-Prefrontal Network Connectivity and Negative Symptoms in Schizophrenia. Am J Psychiatry. 2019 Jul 1;176(7):512-520. doi: 10.1176/appi.ajp.2018.18040429. Epub 2019 Jan 30.
PubMed 30696271
Tang Y, Jiao X, Wang J, Zhu T, Zhou J, Qian Z, Zhang T, Cui H, Li H, Tang X, Xu L, Zhang L, Wei Y, Sheng J, Liu L, Wang J. Dynamic Functional Connectivity Within the Fronto-Limbic Network Induced by Intermittent Theta-Burst Stimulation: A Pilot Study. Front Neurosci. 2019 Sep 13;13:944. doi: 10.3389/fnins.2019.00944. eCollection 2019.
PubMed 31572111
Tang Y, Xu L, Zhu T, Cui H, Qian Z, Kong G, Tang X, Wei Y, Zhang T, Hu Y, Sheng J, Wang J. Visuospatial Learning Selectively Enhanced by Personalized Transcranial Magnetic Stimulation over Parieto-Hippocampal Network among Patients at Clinical High-Risk for Psychosis. Schizophr Bull. 2023 Jul 4;49(4):923-932. doi: 10.1093/schbul/sbad015.
PubMed 36841956
Wei Y, Wang J, Tang X, Qian Z, Xu L, Cui H, Song Y, Zhu H, Ju M, Long B, Zhai W, Zeng L, Jiao X, Lan X, Wei X, Tang Y, Wang J, Zhang T. Neuronavigated dual-target transcranial magnetic stimulation for schizophrenia negative symptoms. Brain. 2026 Oct 15:awag359. doi: 10.1093/brain/awag359. Online ahead of print.
PubMed 42879192
Wang J, Wei Y, Hu Q, Tang Y, Zhu H, Wang J. The efficacy and safety of dual-target rTMS over dorsolateral prefrontal cortex (DLPFC) and cerebellum in the treatment of negative symptoms in first-episode schizophrenia: Protocol for a multicenter, randomized, double-blind, sham-controlled study. Schizophr Res Cogn. 2024 Nov 29;39:100339. doi: 10.1016/j.scog.2024.100339. eCollection 2025 Mar.
PubMed 39687049

Want to know more?

Jijun Wang, M.D, Ph.D

86-21-34773065

jijunwang27@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Repetitive Transcranial Magnetic Stimulation in Subjects With Early Psychosis and The Functional Connectivity Biotypes
ClinicalTrials.gov ID: NCT04853485
Acronym / sponsor ID: CRC2018ZD01
Conditions: Schizophrenia; Psychosis, First Episode Psychosis, Clinical High Risk
Keywords: schizophrenia, prodromal phase, biotypes, target optimizing, precision calculation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 300 participants (estimated)
Lead sponsor: Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Collaborators: Suzhou Psychiatric Hospital, Guangzhou Psychiatric Hospital, Shenzhen Kangning Hospital, Tianjin Anding Hospital, Nantong Fourth People's Hospital & Nantong Brain Hospital
Study start: 1 Aug 2020 (actual)
Primary completion: 31 Dec 2023 (estimated)
Study completion: 31 Dec 2024 (estimated)
First posted: 21 Apr 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Active TMS targeting both cerebellum and right dorsolateral prefrontal cortex.	Active comparator	Device: repetitive transcranial magnetic stimulation (rTMS)Subjects identified as with prominent negative symptoms will be randomized into active group, who will receive active rTMS over cerebellum and right dorsolateral prefrontal cortex navigated by individual MRI.
Sham TMS targeting both cerebellum and right dorsolateral prefrontal cortex	Sham comparator	Device: repetitive transcranial magnetic stimulation (rTMS)Subjects identified as with prominent negative symptoms will be randomized into sham group, who will receive sham rTMS over cerebellum and right dorsolateral prefrontal cortex navigated by individual MRI.
Active TMS targeting left inferior parietal lobule	Active comparator	Device: repetitive transcranial magnetic stimulation (rTMS)Subjects identified with prominent cognition deficits wil be randomized into active group, who will receive active rTMS over left inferior parietal lobule, navigated by individual MRI and functional connectivity map with left hippocampus.
Sham TMS targeting left inferior parietal lobule	Placebo comparator	Device: repetitive transcranial magnetic stimulation (rTMS)Subjects identified with prominent cognition deficits wil be randomized into sham group, who will receive sham rTMS over left inferior parietal lobule, navigated by individual MRI and functional connectivity map with left hippocampus.
Active deep TMS using Brainways H7 coil targeting ACC	Active comparator	Device: repetitive transcranial magnetic stimulation (rTMS)Subjects identified as with positive symptoms will be randomized into active group, who will receive active deep rTMS over ACC using H7 coil.
Sham deep TMS using Brainways H7 coil targeting ACC	Placebo comparator	Device: repetitive transcranial magnetic stimulation (rTMS)Subjects identified with positive symptoms will be randomized into sham group, who will receive sham deep rTMS over ACC using H7 coil.

Who may qualify

Ages: 14 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (12 listed)

Meeting the syndrome of clinical high risk of psychosis, identified by a face-to-face interview using the Chinese version of Structured Interview for Prodromal Syndromes / Scale of Prodromal Symptoms (SIPS/SOPS);
Given the written consent for participation.
Age between 14-45 years old;
IQ>69;
PANSS total scores >= 55 or BVMT-R score <= 26;

Key exclusion criteria (7 listed)

any contraindication to TMS treatment or magnetic resonance imaging (MRI)
substance or alcohol abuse within recent three months
any sensorimotor disorder (e.g., hearing disorder, lose one's sight), or any neurological disease (brain injury, epilepsy ) or any other physical disease which may lead to psychotic symptoms.
For subjects with first-episode schizophrenia
any contraindication to TMS treatment or magnetic resonance imaging (MRI)

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 stimulation (rTMS)All subjects with early psychosis will be divided into three subgroups determined by their psychotic symptoms and cognition. There are three rTMS strategies: (1) For subgroup 1, characterized by negative symptoms, iTBS over cerebellum and 1 Hz over right DLPFC; (2) For subgroup 2, characterized by cognition deficits, 20 Hz over the left inferior parietal cortex; (3) For subgroup 3, characterized by positive symptoms: 10 Hz over ACC. Ten to twenty sessions of rTMS will be delivered to each patients during the intervention period.	Device	Active TMS targeting both cerebellum and right dorsolateral prefrontal cortex., Active TMS targeting left inferior parietal lobule, Active deep TMS using Brainways H7 coil targeting ACC, Sham TMS targeting both cerebellum and right dorsolateral prefrontal cortex, Sham TMS targeting left inferior parietal lobule, Sham deep TMS using Brainways H7 coil targeting ACC

Primary outcome

Response rate (the number of non-responders) for subgroup 1 and subgroup 3
Time frame: Within 24 hours after the rTMS intervention
Response or responder will be determined by the reduction of PANSS total scores >= 25%
Improvement on cognition for subgroup 2
Time frame: Within 24 hours after the rTMS intervention
Change in BVMT-R score as measured by MCCB

9 secondary outcomes

Improvement of psychotic symptoms
Time frame: Within 24 hours after the rTMS intervention
Improvement of prodromal symptoms
Time frame: Within 24 hours after the rTMS intervention
Improvement of cognitive function
Time frame: Within 24 hours after the rTMS intervention
Improvement of global functioning
Time frame: Within 24 hours after the rTMS intervention
Functional connectivity
Time frame: Within 1week after the rTMS intervention
side effect and safety
Time frame: during and after rTMS intervention
clinical outcome
Time frame: 1 year
The accuracy of prediction with functional connectivity biotypes at baseline
Time frame: 1 year
change in individualized psychosis risk score
Time frame: Within 24 hours after the rTMS intervention

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
Background: PubMed 32694037Cui H, Giuliano AJ, Zhang T, Xu L, Wei Y, Tang Y, Qian Z, Stone LM, Li H, Whitfield-Gabrieli S, Niznikiewicz M, Keshavan MS, Shenton ME, Wang J, Stone WS. Cognitive dysfunction in a psychotropic medication-naive, clinical high-risk sample from the ShangHai-At-Risk-for-Psychosis (SHARP) study: Associations with clinical outcomes. Schizophr Res. 2020 Dec;226:138-146. doi: 10.1016/j.schres.2020.06.018. Epub 2020 Jul 18.
Background: PubMed 28765677Wang J, Zhou Y, Gan H, Pang J, Li H, Wang J, Li C. Efficacy Towards Negative Symptoms and Safety of Repetitive Transcranial Magnetic Stimulation Treatment for Patients with Schizophrenia: A Systematic Review. Shanghai Arch Psychiatry. 2017 Apr 25;29(2):61-76. doi: 10.11919/j.issn.1002-0829.217024.
Background: PubMed 31190822Zhuo K, Tang Y, Song Z, Wang Y, Wang J, Qian Z, Li H, Xiang Q, Chen T, Yang Z, Xu Y, Fan X, Wang J, Liu D. Repetitive transcranial magnetic stimulation as an adjunctive treatment for negative symptoms and cognitive impairment in patients with schizophrenia: a randomized, double-blind, sham-controlled trial. Neuropsychiatr Dis Treat. 2019 May 8;15:1141-1150. doi: 10.2147/NDT.S196086. eCollection 2019.
Background: PubMed 30696271Brady RO Jr, Gonsalvez I, Lee I, Ongur D, Seidman LJ, Schmahmann JD, Eack SM, Keshavan MS, Pascual-Leone A, Halko MA. Cerebellar-Prefrontal Network Connectivity and Negative Symptoms in Schizophrenia. Am J Psychiatry. 2019 Jul 1;176(7):512-520. doi: 10.1176/appi.ajp.2018.18040429. Epub 2019 Jan 30.
Background: PubMed 31572111Tang Y, Jiao X, Wang J, Zhu T, Zhou J, Qian Z, Zhang T, Cui H, Li H, Tang X, Xu L, Zhang L, Wei Y, Sheng J, Liu L, Wang J. Dynamic Functional Connectivity Within the Fronto-Limbic Network Induced by Intermittent Theta-Burst Stimulation: A Pilot Study. Front Neurosci. 2019 Sep 13;13:944. doi: 10.3389/fnins.2019.00944. eCollection 2019.
Background: PubMed 36841956Tang Y, Xu L, Zhu T, Cui H, Qian Z, Kong G, Tang X, Wei Y, Zhang T, Hu Y, Sheng J, Wang J. Visuospatial Learning Selectively Enhanced by Personalized Transcranial Magnetic Stimulation over Parieto-Hippocampal Network among Patients at Clinical High-Risk for Psychosis. Schizophr Bull. 2023 Jul 4;49(4):923-932. doi: 10.1093/schbul/sbad015.
Derived from this study: PubMed 42879192Wei Y, Wang J, Tang X, Qian Z, Xu L, Cui H, Song Y, Zhu H, Ju M, Long B, Zhai W, Zeng L, Jiao X, Lan X, Wei X, Tang Y, Wang J, Zhang T. Neuronavigated dual-target transcranial magnetic stimulation for schizophrenia negative symptoms. Brain. 2026 Oct 15:awag359. doi: 10.1093/brain/awag359. Online ahead of print.
Derived from this study: PubMed 39687049Wang J, Wei Y, Hu Q, Tang Y, Zhu H, Wang J. The efficacy and safety of dual-target rTMS over dorsolateral prefrontal cortex (DLPFC) and cerebellum in the treatment of negative symptoms in first-episode schizophrenia: Protocol for a multicenter, randomized, double-blind, sham-controlled study. Schizophr Res Cogn. 2024 Nov 29;39:100339. doi: 10.1016/j.scog.2024.100339. eCollection 2025 Mar.
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.

Jijun Wang, M.D, Ph.D contact

86-21-34773065

jijunwang27@163.com

Jijun Wang, M.D., Ph.D principal investigator

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 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: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jijun Wang, M.D, Ph.D (86-21-34773065, jijunwang27@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (the number of non-responders) for subgroup 1 and subgroup 3 (time frame: Within 24 hours after the rTMS intervention). The study lists 2 primary outcomes in all. 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 NCT04853485, which also lists 8 linked publications.

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 29 Dec 2023.