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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00875498
First Posted: April 3, 2009
Last Update Posted: January 27, 2016
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.
Information provided by (Responsible Party):
Dr. E. Poulet, Hôpital le Vinatier
  Purpose
The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia.

Condition Intervention
Schizophrenia Procedure: active iTBS Procedure: sham iTBS

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr. E. Poulet, Hôpital le Vinatier:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 22
Study Start Date: November 2008
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00875498


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

Responsible Party: Dr. E. Poulet, PUPH, Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT00875498     History of Changes
Other Study ID Numbers: 2008-A00558-47
First Submitted: April 2, 2009
First Posted: April 3, 2009
Last Update Posted: January 27, 2016
Last Verified: January 2016

Keywords provided by Dr. E. Poulet, Hôpital le Vinatier:
iTBS
Negative Symptoms

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders