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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00875498
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : January 27, 2016
Information provided by (Responsible Party):
Dr. E. Poulet, 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Procedure: active iTBS Procedure: sham iTBS Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia
Study Start Date : November 2008
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: active iTBS
iTBS active intensity = 80%MT during 6 minutes. 20 sessions, 2 per day
Procedure: active iTBS

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

Placebo Comparator: sham iTBS
iTBS placebo (placebo coil)with same parameters than active
Procedure: sham iTBS
iTBS placebo (placebo coil)
Other Names:
  • placebo TMS
  • placebo rTMS

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00875498

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Hopital Le vinatier
Bron, France
Sponsors and Collaborators
Hôpital le Vinatier
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Principal Investigator: Emmanuel Poulet, MD, PhD Hopital Le Vinatier
Study Director: JEROME BRUNELIN, PhD Hopital le Vinatier

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Responsible Party: Dr. E. Poulet, PUPH, Hôpital le Vinatier Identifier: NCT00875498     History of Changes
Other Study ID Numbers: 2008-A00558-47
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Keywords provided by Dr. E. Poulet, Hôpital le Vinatier:
Negative Symptoms
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders