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Modulation of Repetitive Transcranial Magnetic Stimulation on Hippocampal Neurogenesis and Functional Network in Patients With Schizophrenia

Modulation of rTMS on Hippocampal Neurogenesis and Functional Network in Early Schizophrenia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03608462
Enrollment
180
Registered
2018-08-01
Start date
2019-04-01
Completion date
2021-12-31
Last updated
2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

first episode schizophrenia, rTMS, hippocampal neurogenesis, MRS, cognitive function

Brief summary

Based on the hypothesis that high-frequency repetitive transcranial magnetic stimulation(rTMS) on the right dorsolateral prefrontal cortex(DLPFC) and left parietal cortex(LPC) could normalise cognitive abnormalities by promoting hippocampal neurogenesis and cortical-hippocampal function in patients with schizophrenia,this research plan to utilise multimodal functional magnetic imaging method(including structural MRI,resting-state functional magnetic resonance imaging and 1H-MRS) to investigate therapeutic efficacy of intermittent theta burst stimulation (iTBS) on cognitive impairment in SZ patients with memory defects,as well as to elucidate the correlation between treatment effects and hippocampal neuroplasticity.

Detailed description

This study includes 150 schizophrenia patients and 30 healthy controls.This study will investigate 1).abnormalities of hippocampal neurogenesis in patients with schizophrenia compared to healthy controls by using 1H-MRS technique 2a).potential modulation effects of repetitive transcranial magnetic stimulation(rTMS) on hippocampal neurogenesis and cortical-hippocampal function of patients with schizophrenia 2b).the optimal rTMS therapy pattern on promoting hippocampal neurogenesis and improving cortico-hippocampal function by comparing the outcome of stimulating two regions(right dorsolateral prefrontal cortex or left parietal cortex) respectively 3).the therapeutic efficacy of rTMS on cognitive impairments and other psychotic symptoms of patients with schizophrenia by adopting cognitive function and psychotic symptoms evaluation,as well as to explore the optimal rTMS treatment pattern on cognitive function by comparing the outcome of stimulating two regions(DLPFC or LPC) respectively 4)association between therapeutic efficacy of rTMS on cognitive deficits and rTMS modulation on hippocampal neurogenesis and its network function,in order to elucidate the underlying mechanism of therapeutic effects of rTMS on cognitive dysfunction in schizophrenia.

Interventions

DEVICErepetitive transcranial magnetic stimulation(DLPFC)

high frequency(20Hz) repetitive transcranial magnetic stimulation on dorsolateral prefrontal cortex(DLPFC) .Duration:10 days.

DEVICErepetitive transcranial magnetic stimulation(LPC)

high frequency(20Hz) repetitive transcranial magnetic stimulation on left parietal cortex(LPC).Duration:10 days

Sponsors

Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

In this research,we combine a cross-sectional case control study and a randomized controlled study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Early schizophrenia group: Inclusion Criteria: 1. The Structured Interview for Prodromal Symptoms (SIPS) was employed. 2. Meet the diagnostic criteria of Diagnostic and Statistical Manual Diploma in Social Medicine(DSM-V) schizophrenia or schizophreniform psychosis. 3. 18-50years of age,right-handed,normal vision or corrected vision, Han nationality. 4. Disease course less than 5 years. 5. Written informed consent Observation group: First-episode, In addition to criteria1-3,5,antipsychotics naïve,or antipsychotics withdrawal for more than 3 months. Intervention group:In addition to criteria 1-6,currently under medication and medically stable for at least 1 month(PANSS score fluctuation\<10%);continue the original antipsychotics for at least 1 months after recruitment,with consent of the patients,their psychiatrists and family members.

Exclusion criteria

Current or past neurological illness,severe physical illness,substance abuse or addiction,alcohol dependence,mental retardation,pregnancy or lactation,extreme agitation, stupor, negative suicide,or those who can not cooperate.A history of MECT within 6 months,or those with contraindications to MRI,rTMS.Medically unstable for at least 1 month (PANSS score fluctuation\>10%) * Healthy controls: Inclusion Criteria: 1. The Structured Interview for Prodromal Symptoms (SIPS) was employed 2. Matched to the early schizophrenia group in terms of age,sex ratio,handedness,and estimated premorbid IQ 3. normal vision or corrected vision, Han nationality 4. Written informed consent

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in MATRICS Consensus Cognitive Batterybaseline,24 hours after the rTMS treatment,30 daysMATRICS Consensus Cognitive Battery
Change of hippocampal neurogenesis(from baseline)baseline,24 hours after the rTMS treatmentQuantify neural stem cells in hippocampal by using H1-MRS
Change of cortical-hippocampal functional network(from baseline)baseline,24 hours after the rTMS treatmentResting-state fMRI data are acquired
Change from baseline in associative memorybaseline,24 hours after the rTMS treatment,30 daysassociative memory

Secondary

MeasureTime frameDescription
Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)baseline,24 hours after the rTMS treatment,30 daysScale for the Assessment of Negative Symptoms
Change from baseline in UCSD Performance-based Skills Assessment-Brief(UPSA-B)baseline,24 hours after the rTMS treatment,30 daysUCSD Performance-based Skills Assessment-Brief
Change from baseline in Positive and Negative Syndrome Scale(PANSS)baseline,24 hours after the rTMS treatment,30 daysPositive and Negative Syndrome Scale(PANSS)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026