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Clinical Trials/NCT05167942
NCT05167942
Unknown
Not Applicable

Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia

Shanghai Mental Health Center1 site in 1 country87 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Treatment Resistant Schizophrenia Based on the DTMS
Sponsor
Shanghai Mental Health Center
Enrollment
87
Locations
1
Primary Endpoint
Change from baseline in MATRICS Consensus Cognitive Battery
Last Updated
4 years ago

Overview

Brief Summary

Negative symptoms and cognitive dysfunction are of importance for the prognosis of the patients of schizophrenia. Based on the hypothesis that deep transcranial magnetic stimulation(dTMS) on prefrontal cortex #PFC# could down-regulate the glutamate level of PFC and regulate the functional network in patients with treatment resistance 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 high-frequency deep transcranial magnetic stimulation on SZ patients symptoms,as well as to elucidate the correlation between treatment effects and glutamate level of PFC

Detailed Description

This study includes 87 treatment resistance schizophrenia patients. This study will investigate 1)abnormalities of the glutamate level of PFC in patients with schizophrenia compared to healthy controls by using 1H-MRS technique. 2)potential modulation effects of deep transcranial magnetic stimulation(dTMS) on prefrontal cortex function of patients with schizophrenia. 3)the therapeutic efficacy of dTMS 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 dTMS treatment pattern on cognitive function.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
September 30, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with schizophrenia who meet the dsm-5 diagnostic criteria
  • Aged from 18 to 55
  • Right-handedness, normal hearing, visual acuity or corrected visual acuity
  • Written informed consent of the patient and his/her family
  • All patients received MINI 7.0 structured interviews

Exclusion Criteria

  • Patients who are currently taking clozapine or who have failed to respond to a full course of treatment with clozapine
  • 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
  • Medically unstable for at least 1 month

Outcomes

Primary Outcomes

Change from baseline in MATRICS Consensus Cognitive Battery

Time Frame: baseline,24 hours after the rTMS treatment,40 days

MATRICS Consensus Cognitive Battery

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

Time Frame: baseline,24 hours after the dTMS treatment,40 days

Change from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 40 days

Secondary Outcomes

  • Change of PFC neurogenesis(baseline,24 hours after the dTMS treatment,40days)

Study Sites (1)

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