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Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia

Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05167942
Enrollment
87
Registered
2021-12-22
Start date
2021-11-01
Completion date
2023-09-30
Last updated
2021-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Resistant Schizophrenia Based on the DTMS

Keywords

Deep Transcranial Magnetic Stimulation, Treatment Resistant Schizophrenia, H1 coil

Brief 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

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.

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.

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in Positive and Negative Syndrome Scale(PANSS)baseline,24 hours after the dTMS treatment,40 daysChange from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 40 days
Change from baseline in MATRICS Consensus Cognitive Batterybaseline,24 hours after the rTMS treatment,40 daysMATRICS Consensus Cognitive Battery

Secondary

MeasureTime frameDescription
Change of PFC neurogenesisbaseline,24 hours after the dTMS treatment,40daysQuantify neural stem cells in hippocampal by using H1-MRS

Countries

China

Contacts

Primary ContactDengtang Liu, M.D.
erliu110@126.com8618017311138

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026