Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia - Full Text View

Sponsored by:	Hôpital le Vinatier
Information provided by:	Hôpital le Vinatier
ClinicalTrials.gov Identifier:	NCT00875498

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 Negative Symptoms	Procedure: repetitive transcranial magnetic stimulation Procedure: repetitive transcranial magnetic stimulation - placebo

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia

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 ]

Estimated Enrollment:	80
Study Start Date:	November 2008
Estimated Study Completion Date:	June 2011
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator iTBS active intensity = 80%MT during 6 minutes. 20 sessions, 2 per day	Procedure: repetitive transcranial magnetic stimulation Intermittent Theta Burst Stimulation (iTBS) over Left dorsolateral prefrontal cortex. 80% MT, 20 sessions of 6 minutes, 2 per day
2: Placebo Comparator iTBS placebo (placebo coil)	Procedure: repetitive transcranial magnetic stimulation - placebo iTBS placebo (placebo coil)

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.

We 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
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
Informed consent

Exclusion Criteria:

Contraindication to TMS
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875498

Contacts

Contact: Emmanuel Poulet, MD, PhD

33437915100

emmanuel.poulet@ch-le-vinatier.fr

Locations

France
Hopital Le vinatier	Recruiting
Bron, France
Contact: emmanuel poulet 33437915100
Principal Investigator: emmanuel poulet, MD,PhD

Sponsors and Collaborators

Hôpital le Vinatier

Investigators

Principal Investigator:

Emmanuel Poulet, MD, PhD

Hopital Le Vinatier

More Information

No publications provided

Responsible Party:	Hopital le Vinatier ( Emmanuel Poulet, PH )
Study ID Numbers:	2008-A00558-47
Study First Received:	April 2, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00875498 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hôpital le Vinatier:

iTBS

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009