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

January 26, 2016 updated by: Dr. E. Poulet, Hôpital le Vinatier
The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France
        • hopital le Vinatier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
before, after 2 weeks of treatment, and 3 times follow-up (1, 3 and 6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 times, before treatment, immediatly after treatment and a last evaluation 3 months after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital le Vinatier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (ESTIMATE)

April 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-A00558-47

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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