Schizophrenia
Conditions
Keywords
iTBS, Negative Symptoms
Brief summary
The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia.
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).
Interventions
PROCEDUREactive iTBS
Intermittent Theta Burst Stimulation (iTBS) over Left dorsolateral prefrontal cortex. 80% MT, 20 sessions of 6 minutes, 2 per day
PROCEDUREsham iTBS
iTBS placebo (placebo coil)
Sponsors
Hôpital le Vinatier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed