Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
active iTBS
sham iTBS
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring iTBS, Negative Symptoms
Eligibility 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 years old
- Informed consent
Exclusion Criteria:
- Contraindication to TMS
- Pregnancy
Sites / Locations
- Hopital Le vinatier
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
active iTBS
sham iTBS
Arm Description
iTBS active intensity = 80%MT during 6 minutes. 20 sessions, 2 per day
iTBS placebo (placebo coil)with same parameters than active
Outcomes
Primary Outcome Measures
Scale for the Assessment of Negative Symptoms (SANS)
Secondary Outcome Measures
Neurochemical impact of treatment measured by 1H-MRS, DTI and resting MRI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00875498
Brief Title
Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia
Official Title
Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
iTBS, Negative Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active iTBS
Arm Type
Active Comparator
Arm Description
iTBS active intensity = 80%MT during 6 minutes. 20 sessions, 2 per day
Arm Title
sham iTBS
Arm Type
Placebo Comparator
Arm Description
iTBS placebo (placebo coil)with same parameters than active
Intervention Type
Procedure
Intervention Name(s)
active iTBS
Other Intervention Name(s)
TMS, rTMS, TBS, iTBS
Intervention Description
Intermittent Theta Burst Stimulation (iTBS) over Left dorsolateral prefrontal cortex.
80% MT, 20 sessions of 6 minutes, 2 per day
Intervention Type
Procedure
Intervention Name(s)
sham iTBS
Other Intervention Name(s)
placebo TMS, placebo rTMS
Intervention Description
iTBS placebo (placebo coil)
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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 years old
Informed consent
Exclusion Criteria:
Contraindication to TMS
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Poulet, MD, PhD
Organizational Affiliation
Hopital Le Vinatier
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JEROME BRUNELIN, PhD
Organizational Affiliation
Hopital le Vinatier
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Le vinatier
City
Bron
Country
France
12. IPD Sharing Statement
Learn more about this trial
Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia
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