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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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) ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: April 2, 2009
Last Updated: January 26, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hôpital le Vinatier:
iTBS
Negative Symptoms

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

ClinicalTrials.gov processed this record on August 28, 2016