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

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Procedure: sham iTBS; Procedure: active iTBS

• Registration Number: NCT00875498
• Lead Sponsor: Hôpital le Vinatier

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham iTBS	sham iTBS	iTBS placebo (placebo coil)with same parameters than active
active iTBS	active iTBS	iTBS active intensity = 80%MT during 6 minutes. 20 sessions, 2 per day

Primary Outcome Measures

Name	Time	Method
Scale for the Assessment of Negative Symptoms (SANS)	before, after 2 weeks of treatment, and 3 times follow-up (1, 3 and 6 months)

Secondary Outcome Measures

Name	Time	Method
Neurochemical impact of treatment measured by 1H-MRS, DTI and resting MRI	3 times, before treatment, immediatly after treatment and a last evaluation 3 months after

Trial Locations

Locations (1)

Hopital Le vinatier; 🇫🇷 Bron, France