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

NCT ID: NCT00875498

Last Updated: 2016-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2015-07-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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active iTBS

iTBS active intensity = 80%MT during 6 minutes. 20 sessions, 2 per day

Group Type ACTIVE_COMPARATOR

active iTBS

Intervention Type PROCEDURE

Intermittent Theta Burst Stimulation (iTBS) over Left dorsolateral prefrontal cortex.

80% MT, 20 sessions of 6 minutes, 2 per day

sham iTBS

iTBS placebo (placebo coil)with same parameters than active

Group Type PLACEBO_COMPARATOR

sham iTBS

Intervention Type PROCEDURE

iTBS placebo (placebo coil)

Interventions

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active iTBS

Intermittent Theta Burst Stimulation (iTBS) over Left dorsolateral prefrontal cortex.

80% MT, 20 sessions of 6 minutes, 2 per day

Intervention Type PROCEDURE

sham iTBS

iTBS placebo (placebo coil)

Intervention Type PROCEDURE

Other Intervention Names

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TMS rTMS TBS iTBS placebo TMS placebo rTMS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Dr. E. Poulet

PUPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emmanuel Poulet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Le Vinatier

JEROME BRUNELIN, PhD

Role: STUDY_DIRECTOR

Hopital le Vinatier

Locations

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Hopital Le vinatier

Bron, , France

Site Status

Countries

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France

Other Identifiers

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2008-A00558-47

Identifier Type: -

Identifier Source: org_study_id

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