Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia

Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia Clinical Trial

Official title:

Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia: a Double-Blind, Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04478032
• Other study ID #: 20194Y0037
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2021
• Source: Shanghai Mental Health Center
• Contact: Dengtang Liu, M.D.
• Phone: 8618017311138
• Email: erliu110[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Based on the hypothesis that low-frequency deep transcranial magnetic stimulation(dTMS) on anterior cingulate cortex （ACC） could down-regulate the glutamate level of ACC and regulate the acc-related 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 low-frequency deep transcranial magnetic stimulation on SZ patients symptoms,as well as to elucidate the correlation between treatment effects and glutamate level of ACC

Description:

This study includes 20 treatment resistance schizophrenia patients and 20 healthy controls.This study will investigate 1)abnormalities of the glutamate level of ACC in patients with schizophrenia compared to healthy controls by using 1H-MRS technique. 2)potential modulation effects of deep transcranial magnetic stimulation(dTMS) on anterior cingulate 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with schizophrenia who meet the dsm-5 diagnostic criteria
• Aged from 18 to 60
• After 4 weeks of treatment with a sufficient dose of an antipsychotic (equivalent dose of 400 ~ 600 mg/ day chlorpromazine (CPZ)), no clinical improvement was achieved (at least two items in PANSS scale P1,P2,P3,N1,N4,N6,G5 and G9 =4 points, or cgi-s =4 points)
• Right-handedness, normal hearing, visual acuity or corrected visual acuity
• Written informed consent of the patient and his/her family

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
• 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%)

Related Conditions & MeSH terms

• Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia
• Schizophrenia

Intervention

Device:
• deep transcranial magnetic stimulation with H7 coil
low frequency(1Hz) deep transcranial magnetic stimulation on ACC .Duration:20 days.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Positive and Negative Syndrome Scale(PANSS)	Change from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 30 days	baseline,24 hours after the dTMS treatment,30 days
Primary	Change from baseline in MATRICS Consensus Cognitive Battery	MATRICS Consensus Cognitive Battery	baseline,24 hours after the rTMS treatment,30 days
Secondary	Change of ACC neurogenesis	Quantify neural stem cells in hippocampal by using H1-MRS	baseline,24 hours after the dTMS treatment
Secondary	Change in glutamate level		baseline,24 hours after the dTMS treatment