Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia

Hôpital le Vinatier

Status: Completed

Conditions: Schizophrenia

Treatments: Procedure: active iTBS; Procedure: sham iTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT00875498

2008-A00558-47

Details and patient eligibility

About

The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia.

Full description

This study will evaluate whether the intermittent Theta Burst Stimulation (iTBS), a new high frequency TMS protocol is efficient in the treatment of the Negative Symptoms of schizophrenia.

Neuroimaging studies demonstrate that hypoactivity in the left dorsolateral prefrontal cortex (LDLPFC) was associated with negative symptoms.

The investigators hypothesize that iTBS applied to LDLPFC will improve negative symptoms and will improve activity of the LDLPFC measured with Magnetic Resonance Spectroscopy (MRS).

Enrollment: 22 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Schizophrenia according to DSM-IV
• Negative symptoms for at least 6 weeks
• Medication resistance according to Kane et al., 1988
• Age between 18 and 50 years old
• Informed consent

Exclusion criteria

• Contraindication to TMS
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

active iTBS

Active Comparator group

Description:

iTBS active intensity = 80%MT during 6 minutes. 20 sessions, 2 per day

Treatment:

Procedure: active iTBS

sham iTBS

Placebo Comparator group

Description:

iTBS placebo (placebo coil)with same parameters than active

Treatment:

Procedure: sham iTBS