Repetitive Transcranial Magnetic Stimulation in Early Psychosis and The Functional Connectivity Biotypes
NCT ID: NCT04853485
Last Updated: 2023-12-29
Study Results
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Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2020-08-01
2024-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active TMS targeting both cerebellum and right dorsolateral prefrontal cortex.
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.
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.
Sham TMS targeting both cerebellum and right dorsolateral prefrontal cortex
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.
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.
Active TMS targeting left inferior parietal lobule
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.
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.
Sham TMS targeting left inferior parietal lobule
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.
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.
Active deep TMS using Brainways H7 coil targeting ACC
Subjects identified as with positive symptoms will be randomized into active group, who will receive active deep rTMS over ACC using H7 coil.
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.
Sham deep TMS using Brainways H7 coil targeting ACC
Subjects identified with positive symptoms will be randomized into sham group, who will receive sham deep rTMS over ACC using H7 coil.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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;
* 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
Exclusion Criteria
* 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.
14 Years
45 Years
ALL
No
Sponsors
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Suzhou Psychiatric Hospital
OTHER
Guangzhou Psychiatric Hospital
OTHER_GOV
Shenzhen Kangning Hospital
OTHER
Tianjin Anding Hospital
OTHER
Nantong Fourth People's Hospital & Nantong Brain Hospital
UNKNOWN
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Jijun Wang
Professor of Department of Psychiatry
Principal Investigators
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Jijun Wang, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Locations
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The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Nantong Fourth People's Hospital & Nantong Brain Hospital
Nantong, Jiangsu, China
Suzhou Guangji Hospital
Suzhou, Jiangsu, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Shenzhen Kangning Hospital
Shenzhen, , China
Tianjin Anding Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Liping Cao
Role: primary
Xing Chen
Role: primary
Li Hui, PhD
Role: primary
Jijun Wang, MD, PhD
Role: primary
Lingyun Zeng
Role: primary
Bin Zhang
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CRC2018ZD01
Identifier Type: -
Identifier Source: org_study_id