Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia
|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|
- 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 ]
- 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 ]
|Study Start Date:||November 2008|
|Study Completion Date:||July 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
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
Placebo Comparator: sham iTBS
iTBS placebo (placebo coil)with same parameters than active
Procedure: sham iTBS
iTBS placebo (placebo coil)
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875498
|Hopital Le vinatier|
|Principal Investigator:||Emmanuel Poulet, MD, PhD||Hopital Le Vinatier|
|Study Director:||JEROME BRUNELIN, PhD||Hopital le Vinatier|