NCT04478032

Brief 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

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

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

Study Start

First participant enrolled

July 5, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 14, 2021

Status Verified

July 1, 2021

Enrollment Period

2.4 years

First QC Date

July 16, 2020

Last Update Submit

September 12, 2021

Conditions

Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia

Keywords

Treatment Resistance SchizophreniaDeep Transcranial Magnetic Stimulationanterior cingulate cortexglutamateH7 coil

Outcome Measures

Primary Outcomes (2)

  • 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

  • Change from baseline in MATRICS Consensus Cognitive Battery

    MATRICS Consensus Cognitive Battery

    baseline,24 hours after the rTMS treatment,30 days

Secondary Outcomes (2)

  • Change of ACC neurogenesis

    baseline,24 hours after the dTMS treatment

  • Change in glutamate level

    baseline,24 hours after the dTMS treatment

Study Arms (2)

sham stimulation

SHAM COMPARATOR

20 patients will be randomly allocated into this group,they will receive sham stimulation.

Device: deep transcranial magnetic stimulation with H7 coil

real stimulation dTMS targeting the ACC

ACTIVE COMPARATOR

20 patients will be randomly allocated into this group,they will receive real stimulation.

Device: deep transcranial magnetic stimulation with H7 coil

Interventions

deep transcranial magnetic stimulation with H7 coilDEVICE

low frequency(1Hz) deep transcranial magnetic stimulation on ACC .Duration:20 days.

real stimulation dTMS targeting the ACCsham stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Central Study Contacts

Dengtang Liu, M.D.

CONTACT

8618017311138erliu110@126.com

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 16, 2020

First Posted

July 20, 2020

Study Start

July 5, 2020

Primary Completion

December 1, 2022

Study Completion

December 30, 2022

Last Updated

September 14, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)