Repetitive Transcranial Magnetic Stimulation in Early Psychosis and The Functional Connectivity Biotypes
1 other identifier
interventional
300
1 country
6
Brief 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. The clinical augmentation efficacy will be associated with the brain functional connectivity of these populations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 31, 2021
CompletedFirst Posted
Study publicly available on registry
April 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedDecember 29, 2023
December 1, 2023
3.4 years
March 31, 2021
December 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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%
Within 24 hours after the rTMS intervention
Improvement on cognition for subgroup 2
Change in BVMT-R score as measured by MCCB
Within 24 hours after the rTMS intervention
Secondary Outcomes (9)
Improvement of psychotic symptoms
Within 24 hours after the rTMS intervention
Improvement of prodromal symptoms
Within 24 hours after the rTMS intervention
Improvement of cognitive function
Within 24 hours after the rTMS intervention
Improvement of global functioning
Within 24 hours after the rTMS intervention
Functional connectivity
Within 1week after the rTMS intervention
- +4 more secondary outcomes
Study Arms (6)
Active TMS targeting both cerebellum and right dorsolateral prefrontal cortex.
ACTIVE COMPARATORSubjects 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 COMPARATORSubjects 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 COMPARATORSubjects 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 COMPARATORSubjects 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 COMPARATORSubjects 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 COMPARATORSubjects identified with positive symptoms will be randomized into sham group, who will receive sham deep rTMS over ACC using H7 coil.
Interventions
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
You may qualify if:
- 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;
You may not qualify if:
- 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
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Jiao Tong University School of Medicinelead
- Suzhou Psychiatric Hospitalcollaborator
- Guangzhou Psychiatric Hospitalcollaborator
- Shenzhen Kangning Hospitalcollaborator
- Tianjin Anding Hospitalcollaborator
- Nantong Fourth People's Hospital & Nantong Brain Hospitalcollaborator
Study Sites (6)
The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Nantong Fourth People's Hospital & Nantong Brain Hospital
Nantong, Jiangsu, 226000, China
Suzhou Guangji Hospital
Suzhou, Jiangsu, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
Shenzhen Kangning Hospital
Shenzhen, China
Tianjin Anding Hospital
Tianjin, China
Related Publications (7)
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.
PMID: 32694037BACKGROUNDWang 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.
PMID: 28765677BACKGROUNDZhuo 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.
PMID: 31190822BACKGROUNDBrady 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.
PMID: 30696271BACKGROUNDTang 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.
PMID: 31572111BACKGROUNDTang 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.
PMID: 36841956BACKGROUNDWang 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.
PMID: 39687049DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jijun Wang, M.D., Ph.D
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Department of Psychiatry
Study Record Dates
First Submitted
March 31, 2021
First Posted
April 21, 2021
Study Start
August 1, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
December 29, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share