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Completed

NCT Number: NCT00875498

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Le vinatier

Bron, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active iTBS

Procedure

Intermittent Theta Burst Stimulation (iTBS) over Left dorsolateral prefrontal cortex.

80% MT, 20 sessions of 6 minutes, 2 per day

Other names: TMS, rTMS, TBS, iTBS

sham iTBS

Procedure

iTBS placebo (placebo coil)

Other names: placebo TMS, placebo rTMS

Primary outcomes

  1. Scale for the Assessment of Negative Symptoms (SANS)

    Time frame: before, after 2 weeks of treatment, and 3 times follow-up (1, 3 and 6 months)

Secondary outcomes

  1. Neurochemical impact of treatment measured by 1H-MRS, DTI and resting MRI

    Time frame: 3 times, before treatment, immediatly after treatment and a last evaluation 3 months after

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2009
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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