Repetitive Transcranial Magnetic Stimulation for the Treatment of Negative Symptoms in Schizophrenia Patients.

Shanghai Mental Health Center

Status: Unknown

Conditions: Schizophrenia

Treatments: Device: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02842034

rTMS-negative symptoms

Details and patient eligibility

About

This study is to determine whether high frequency repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia patients

Full description

The principal objective of this trial is to investigate the effect of high frequency rTMS on negative symptoms in schizophrenia.

Enrollment: 60 estimated patients

Sex: All

Ages: 15 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The diagnosis of schizophrenia according to DSM-IV；
• 18～55 years old；
• schizophrenic illness duration longer than one year;
• The sum of negative scores in the range Positive and negative symptom score (PANSS) must be 20 points or higher, at least one item from the area of negative symptoms (N1-N7) must be ≥ 4 points (at least moderate, clinically significant symptoms), and improvement in negative symptom-sum (measuring by PANSS) must be 10% or lower during the last two weeks before rTMS stimulation.
• Have a stable and consistent drug treatment at least two weeks prior the rTMS treatment;
• Able to adhere to the treatment schedule;
• IQ≥80;
• Dextromanual, normal vision and hearing;
• Signed an informed consent

Exclusion criteria

• rTMS contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure;
• Acute risk of suicide and impulse；
• patients to be diagnosed according to DSM-IV for substance abused, development delayed;
• suffering from serious physical disease and can not accept the treatment;
• history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG;
• difficult to maintain the current drug treatment for at least 1 month;
• undergoing ECT or MECT in last 3 months;
• current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Active rTMS

Active Comparator group

Description:

Active treatment will be delivered at an intensity that is 120% of the resting motor threshold (RMT). Stimulation will be delivered at 10 Hz with 60 stimulation trains of 50 stimuli each (i.e., 3000 stimuli) and an intertrain interval of 10 sec. Treatment will be applied in sequential order to the dorsomedial prefrontal cortices (DMPFC).

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

Sham Comparator group

Description:

Sham stimulation will be delivered using the same stimulation parameters and at the same site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation