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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03608462
• Other study ID #: YG2017ZD13
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

• 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

Exclusion Criteria:

History of psychiatric disease in the subjects themselves or a family history of mental disorder in their first-degree relatives,neurological illness,severe physical illness,substance abuse or alcohol dependence,mental retardation.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in MATRICS Consensus Cognitive Battery	MATRICS Consensus Cognitive Battery	baseline,24 hours after the rTMS treatment,30 days
Primary	Change of hippocampal neurogenesis(from baseline)	Quantify neural stem cells in hippocampal by using H1-MRS	baseline,24 hours after the rTMS treatment
Primary	Change of cortical-hippocampal functional network(from baseline)	Resting-state fMRI data are acquired	baseline,24 hours after the rTMS treatment
Primary	Change from baseline in associative memory	associative memory	baseline,24 hours after the rTMS treatment,30 days
Secondary	Change from baseline in Positive and Negative Syndrome Scale(PANSS)	Positive and Negative Syndrome Scale(PANSS)	baseline,24 hours after the rTMS treatment,30 days
Secondary	Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)	Scale for the Assessment of Negative Symptoms	baseline,24 hours after the rTMS treatment,30 days
Secondary	Change from baseline in UCSD Performance-based Skills Assessment-Brief(UPSA-B)	UCSD Performance-based Skills Assessment-Brief	baseline,24 hours after the rTMS treatment,30 days