NCT03608462

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 27, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

July 9, 2018

Last Update Submit

September 23, 2021

Conditions

Schizophrenia

Keywords

first episode schizophreniarTMShippocampal neurogenesisMRScognitive function

Outcome Measures

Primary Outcomes (4)

  • Change from baseline in MATRICS Consensus Cognitive Battery

    MATRICS Consensus Cognitive Battery

    baseline,24 hours after the rTMS treatment,30 days

  • Change of hippocampal neurogenesis(from baseline)

    Quantify neural stem cells in hippocampal by using H1-MRS

    baseline,24 hours after the rTMS treatment

  • Change of cortical-hippocampal functional network(from baseline)

    Resting-state fMRI data are acquired

    baseline,24 hours after the rTMS treatment

  • Change from baseline in associative memory

    associative memory

    baseline,24 hours after the rTMS treatment,30 days

Secondary Outcomes (3)

  • Change from baseline in Positive and Negative Syndrome Scale(PANSS)

    baseline,24 hours after the rTMS treatment,30 days

  • Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)

    baseline,24 hours after the rTMS treatment,30 days

  • Change from baseline in UCSD Performance-based Skills Assessment-Brief(UPSA-B)

    baseline,24 hours after the rTMS treatment,30 days

Study Arms (3)

rTMS targeting the right DLPFC

SHAM COMPARATOR

60 patients will be randomly allocated into this group,half of them will receive iTBS on the right DLPFC,while the other half will receive sham stimulation.

Device: repetitive transcranial magnetic stimulation(DLPFC)

rTMS targeting the left LPC

SHAM COMPARATOR

60 patients will be randomly allocated into this group,half of them will receive iTBS on left LPC,while the other half will receive sham stimulation.

Device: repetitive transcranial magnetic stimulation(LPC)

Observation group

NO INTERVENTION

To investigate the abnormalities of hippocampal neurogenesis in patients with early schizophrenia(n=30) compared to healthy controls(n=30)

Interventions

repetitive transcranial magnetic stimulation(DLPFC)DEVICE

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

rTMS targeting the right DLPFC
repetitive transcranial magnetic stimulation(LPC)DEVICE

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

rTMS targeting the left LPC

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The Structured Interview for Prodromal Symptoms (SIPS) was employed.
  • Meet the diagnostic criteria of Diagnostic and Statistical Manual Diploma in Social Medicine(DSM-V) schizophrenia or schizophreniform psychosis.
  • years of age,right-handed,normal vision or corrected vision, Han nationality.
  • Disease course less than 5 years.
  • 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.

You may not qualify if:

  • 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:
  • The Structured Interview for Prodromal Symptoms (SIPS) was employed
  • Matched to the early schizophrenia group in terms of age,sex ratio,handedness,and estimated premorbid IQ
  • normal vision or corrected vision, Han nationality
  • Written informed consent
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

  • Li X, Xiang Q, Cen H, Zhai Z, Gao T, Lu C, Dong Y, Ye Y, Zhang C, Zhuo K, Wang Y, Liu D. Efficacy of Cortical-Hippocampal Target Intermittent Theta Burst Stimulation (iTBS) on Associative Memory of Schizophrenia: A Double-Blind, Randomized Sham-Controlled Trial. Neuropsychiatr Dis Treat. 2024 Oct 10;20:1941-1955. doi: 10.2147/NDT.S468219. eCollection 2024.

    PMID: 39411184DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In this research,we combine a cross-sectional case control study and a randomized controlled study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

August 1, 2018

Study Start

April 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

September 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)