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

NCT00875498 — Not applicable, Completed, 22 participants, Hôpital le Vinatier

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Registry	NCT00875498
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	22 (Actual)
Sponsor	Hôpital le Vinatier (Other)
Conditions	Schizophrenia
Interventions	active iTBS, sham iTBS (Procedure)
Dates	start 2008-11-01, primary completion 2015-07-01, completion 2015-07-01, first posted 2009-04-03, last updated 2016-01-27
Locations	1 site in France

-Summary

The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia.

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+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).

+Arms and interventions

Arm	Type	Interventions	Description
active iTBS	Active comparator	Procedure: active iTBS	iTBS active intensity = 80%MT during 6 minutes. 20 sessions, 2 per day
sham iTBS	Placebo comparator	Procedure: sham iTBS	iTBS placebo (placebo coil)with same parameters than active

active iTBS (Procedure), also known as TMS, rTMS, TBS, iTBS: Intermittent Theta Burst Stimulation (iTBS) over Left dorsolateral prefrontal cortex. 80% MT, 20 sessions of 6 minutes, 2 per day
sham iTBS (Procedure), also known as placebo TMS, placebo rTMS: iTBS placebo (placebo coil)

+Outcome measures

Primary outcomes

Scale for the Assessment of Negative Symptoms (SANS) [before, after 2 weeks of treatment, and 3 times follow-up (1, 3 and 6 months)]

Secondary outcomes

Neurochemical impact of treatment measured by 1H-MRS, DTI and resting MRI [3 times, before treatment, immediatly after treatment and a last evaluation 3 months after]

+Eligibility

Sex: All, ages: 18 Years to 50 Years

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

+Locations (1)

Facility	City	Country	Status
Hopital Le vinatier	Bron	France

+Investigators

Emmanuel Poulet, MD, PhD, Principal investigator, Hopital Le Vinatier
JEROME BRUNELIN, PhD, Study director, Hopital le Vinatier

My Notes

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