Optimal rTMS for Cognitive Deficits and Negative Symptoms in Schizophrenia

Shanghai Mental Health Center

Status: Enrolling

Conditions: Cognitive Impairment; Negative Symptoms in Schizophrenia; Schizophrenia; Repetitive Transcranial Magnetic Stimulation; Dorsolateral Prefrontal Cortex

Treatments: Device: Bilateral Active Repetitive transcranial magnetic stimulation (rTMS); Device: Left Active Repetitive transcranial magnetic stimulation (rTMS); Device: Sham rTMS over bilateral dorsolateral prefrontal cortex

Study type: Interventional

Funder types: Other

Identifiers

NCT05599373

XHJW2020KY003

Details and patient eligibility

About

Negative symptoms and cognition decline are major challenges in clinical management of schizophrenia. Dorsomedial prefrontal cortex (DLPFC) has been highly involved in the mechanisms of negative symptoms and cognitive symptoms of schizophrenia. However, the effect of repetitive transcranial magnetic stimulation (rTMS) over left or bilateral DLPFC has not yet been well studied. The aim of this study is to describe how the effectiveness of rTMS over different targets for cognitive deficits and negative symptoms in schizophrenia will be evaluated. The study will provide evidence to determine whether a bilateral DLPFC rTMS and is more effective than a left DLPFC rTMS alone to optimize treatment protocol in schizophrenia.

Full description

The study will be a randomized, double-blind trial comparing active rTMS over bilateral DLPFC vs. active rTMS over left DLPFC vs. sham rTMS delivered over DLPFC an 4-week treatment period. After assessment and inclusion into the study, participants will be randomized to receive up to 20 sessions of either active rTMS over left DLPFC or bilateral DLPFC or placebo treatments.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Met the Diagnostic and Statistical Manual of Mental Disorders, Five Edition (DSM-V) diagnostic criteria for schizophrenia and the diagnosis was verified by an experienced psychiatrist based on the Mini-International Neuropsychiatric Interview (MINI) 7.0 .
• Age between 18 and 60.
• Patients with prominently negative symptoms, which was defined as: PANSS negative subscore≥15 points and one of items N1-N7 scoring≥4.
• All patients were in stable clinical conditions (reduction rate of PANSS score<10% within 4 weeks), stable antipsychotic treatment for at least 4 weeks, and able to provide informed consent.

Exclusion criteria

• Any contraindication for rTMS (e.g., intracranial metal, pacemakers, cochlear and intracranial hypertension).
• Unstable clinical condition (e.g., being aggressive and uncooperative).
• Current substance abuse.
• Any other psychiatric diagnosis.
• Significant medical condition including neurological disease, severe cardiovascular, hepatic, renal diseases.
• Previous treatment with modified electric convulsive therapy (MECT) within 3 months before enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Active rTMS over bilateral dorsolateral prefrontal cortex

Active Comparator group

Description:

Active rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.

Treatment:

Device: Bilateral Active Repetitive transcranial magnetic stimulation (rTMS)

Active rTMS over left dorsolateral prefrontal cortex

Active Comparator group

Description:

Active rTMS over left dorsolateral prefrontal cortex and sham rTMS over right dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.

Treatment:

Device: Left Active Repetitive transcranial magnetic stimulation (rTMS)

Sham rTMS over bilateral dorsolateral prefrontal cortex

Sham Comparator group

Description:

Sham rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.

Treatment:

Device: Sham rTMS over bilateral dorsolateral prefrontal cortex