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Multi-target TMS for Schizophrenia Negative Symptoms

ConditionSCHIZOPHRENIA 1 (Disorder)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-45
SponsorShanghai Mental Health Center

About this trial

This randomized controlled trial (RCT) is the first to evaluate the efficacy and safety of a multi-target TMS protocol targeting the right orbitofrontal cortex (R-OFC), left dorsolateral prefrontal cortex (L-DLPFC), and left inferior parietal lobule (L-IPL) for negative symptoms of schizophrenia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Outpatients or inpatients at the Department of Psychiatry, Shanghai Mental Health Center;

Meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for first-episode schizophrenia (diagnosed using the Structured Clinical Interview for DSM-5, SCID-5); disease duration less than 5 years at enrollment;

Male or female aged 16-45 years;

Education duration ≥ 9 years;

Disqualifiers

Current or lifetime psychiatric disorders as determined by SCID-5 assessment;

Severe or unstable physical illnesses, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension, hyperglycemia, malignant tumors, and immunocompromised conditions;

Alcohol abuse within 30 days prior to the study or alcohol/drug dependence within 6 months prior to the study; participation in any clinical trial within 30 days prior to baseline;

Pregnant or breastfeeding women;

Trial design

Design model

Parallel

Treatments tested in this trial

  • repetitive transcranial magnetic stimulation (rTMS)

    Device

    Repetitive transcranial magnetic stimulation (rTMS) is a recently developed neuromodulation technique.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: TMS intervention targeting multiple targetsActive comparator 1 intervention
Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in severity of negative symptoms before and after TMS intervention, i.e., change in Positive and Negative Syndrome Scale - Negative subscale (PANSS-N)

Schizophrenia negative symptoms assessed using Positive and Negative Syndrome Scale - Negative subscale (PANSS-N) Minimum value: 7 (each of the 7 items scored 1 = absent) Maximum value: 49 (each of the 7 items scored 7 = extreme) Higher score indicates: Worse outcome (greater severity of negative symptoms)

Time frame
Negative symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.

Secondary outcomes

1

Change in cognitive function scores before and after intervention

MATRICS Consensus Cognitive Battery (MCCB) total score and subtest scores

Time frame
MATRICS Consensus Cognitive Battery (MCCB) will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and 4 weeks ( Day 42) after completion of TMS treatment.
2

Change in positive symptom scores before and after intervention

Positive and Negative Syndrome Scale - Positive subscale (PANSS-P) Minimum value: 7 (each of the 7 items scored 1 = absent) Maximum value: 49 (each of the 7 items scored 7 = extreme) Higher score indicates: Worse outcome (greater severity of positive symptoms)

Time frame
Positive symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.
3

Change in general symptom scores before and after intervention

Global Assessment of Functioning (GAF) score. The score ranges from 0 to 100 points. Higher scores indicate better levels of functioning.

Time frame
General symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.
4

Change in anxiety symptoms before and after intervention

Anxiety symptoms measured using Hamilton Anxiety Rating Scale (HAMA). Each item scored 0 (not present) to 4 (severe), total score range 0-56. Higher scores indicate more severe symptoms.

Time frame
Anxiety symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Mental Health Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: