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Status unknownNCT05167942Updated Dec 22, 2021

Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia

An interventional study of deep transcranial magnetic stimulation with H1 coil and High frequency deep transcranial magnetic stimulation with H1 coil in Treatment Resistant Schizophrenia Based on the DTMS, sponsored by Shanghai Mental Health Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-12-22.

Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Treatment Resistant Schizophrenia Based on the DTMS

Keywords

  • Deep Transcranial Magnetic Stimulation
  • Treatment Resistant Schizophrenia
  • H1 coil
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In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 87 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
87 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Devicedeep transcranial magnetic stimulation with H1 coil

    Sham deep transcranial magnetic stimulation on PFC .Duration:40 days.

  • DeviceHigh frequency deep transcranial magnetic stimulation with H1 coil

    high frequency(20Hz) deep transcranial magnetic stimulation on PFC .Duration:40 days.

  • DeviceiTBS deep transcranial magnetic stimulation with H1 coil

    iTBS deep transcranial magnetic stimulation on PFC .Duration:40 days.

06

What researchers measure

Primary outcomes

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

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

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

  2. Change from baseline in MATRICS Consensus Cognitive Battery

    MATRICS Consensus Cognitive Battery

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

Secondary outcomes

  1. Change of PFC neurogenesis

    Quantify neural stem cells in hippocampal by using H1-MRS

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

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Study locations

1 of 1 sites recruiting
  • Shanghai Mental Health Center
    Shanghai, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05167942
Lead sponsor
Shanghai Mental Health Center
Responsible party
Sponsor
First posted
Dec 22, 2021
Start date
Nov 1, 2021
Primary completion
Sep 2023 (estimated)
Completion
Sep 30, 2023 (estimated)
Last update
Dec 22, 2021

Study contacts

Dengtang Liu, M.D.
Contact
erliu110@126.com
8618017311138

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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