Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia

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

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

Study Overview

• Status: Recruiting
• Conditions: Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia
• Intervention / Treatment: Device: deep transcranial magnetic stimulation with H7 coil

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Mental Health Center
      • Contact: Dengtang LIU; Phone Number: 8618017311138; Email: erliu110@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sham stimulation; 20 patients will be randomly allocated into this group,they will receive sham stimulation.	Device: deep transcranial magnetic stimulation with H7 coil; low frequency(1Hz) deep transcranial magnetic stimulation on ACC .Duration:20 days.
Active Comparator: real stimulation dTMS targeting the ACC; 20 patients will be randomly allocated into this group,they will receive real stimulation.	Device: deep transcranial magnetic stimulation with H7 coil; low frequency(1Hz) deep transcranial magnetic stimulation on ACC .Duration:20 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in MATRICS Consensus Cognitive Battery	MATRICS Consensus Cognitive Battery	baseline,24 hours after the rTMS treatment,30 days
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of ACC neurogenesis	Quantify neural stem cells in hippocampal by using H1-MRS	baseline,24 hours after the dTMS treatment
Change in glutamate level		baseline,24 hours after the dTMS treatment

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: glutamate; Deep Transcranial Magnetic Stimulation; Treatment Resistance Schizophrenia; anterior cingulate cortex; H7 coil
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 20194Y0037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No