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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
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring iTBS, Negative Symptoms

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 2, 2009
Last Updated
January 26, 2016
Sponsor
Hôpital le Vinatier
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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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