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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. E. Poulet, Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT00875498
First received: April 2, 2009
Last updated: January 26, 2016
Last verified: January 2016

April 2, 2009
January 26, 2016
November 2008
July 2015   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00875498 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia
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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • Procedure: sham iTBS
    iTBS placebo (placebo coil)
    Other Names:
    • placebo TMS
    • placebo rTMS
  • Active Comparator: active iTBS
    iTBS active intensity = 80%MT during 6 minutes. 20 sessions, 2 per day
    Intervention: Procedure: active iTBS
  • Placebo Comparator: sham iTBS
    iTBS placebo (placebo coil)with same parameters than active
    Intervention: Procedure: sham iTBS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00875498
2008-A00558-47
Yes
Not Provided
Not Provided
Dr. E. Poulet, Hôpital le Vinatier
Hôpital le Vinatier
Not Provided
Principal Investigator: Emmanuel Poulet, MD, PhD Hopital Le Vinatier
Study Director: JEROME BRUNELIN, PhD Hopital le Vinatier
Hôpital le Vinatier
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP