Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia

December 10, 2021 updated by: Shanghai Mental Health Center
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Sham dTMS
29 patients will be randomly allocated into this group,they will receive sham stimulation.
Device: deep transcranial magnetic stimulation with H1 coil
Sham deep transcranial magnetic stimulation on PFC .Duration:40 days.
ACTIVE_COMPARATOR: dTMS 20Hz
29 patients will be randomly allocated into this group,they will receive real stimulation.
Device: High frequency deep transcranial magnetic stimulation with H1 coil
high frequency(20Hz) deep transcranial magnetic stimulation on PFC .Duration:40 days.
ACTIVE_COMPARATOR: dTMS iTBS
29 patients will be randomly allocated into this group,they will receive real stimulation.
Device: iTBS deep transcranial magnetic stimulation with H1 coil
iTBS deep transcranial magnetic stimulation on PFC .Duration:40 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline,24 hours after the dTMS treatment,40 days
Change from baseline in MATRICS Consensus Cognitive Battery
Time Frame: baseline,24 hours after the rTMS treatment,40 days
MATRICS Consensus Cognitive Battery
baseline,24 hours after the rTMS treatment,40 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of PFC neurogenesis
Time Frame: baseline,24 hours after the dTMS treatment,40days
Quantify neural stem cells in hippocampal by using H1-MRS
baseline,24 hours after the dTMS treatment,40days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2021

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

September 30, 2023

Study Registration Dates

First Submitted

December 10, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (ACTUAL)

December 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20y11906300

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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