Low and High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Resistant Auditory Hallucination in Schizophrenia

NCT ID: NCT02175251

Last Updated: 2023-09-08

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-09-29

Brief Summary

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Auditory Hallucinations (AH) are experienced by 50 to 70% of subjects with schizophrenia. Almost a quarter of patients are medication resistant to such symptoms. The application of rTMS at low frequency in the left temporoparietal cortex reduces AH. A pilot study reported successful treatment of AH with high frequency rTMS. rTMS (20Hz) should be a shorter and an easier treatment for out-patients with schizophrenia compared to low stimulation treatment.

Detailed Description

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90 schizophrenia patients Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV-TR) criteria with persistent Auditory Hallucinations (AH) resistant to antipsychotic treatments will be recruited. A double blind sham-controlled randomized parallel study comparing three groups treated 10 session in 5 days with high frequency (20 Hz), low frequency (1Hz) and sham-controlled condition rTMS. They will be followed 3 month and evaluated using Auditive Hallucination Rating Scale (AHRS), Scale for the Assessment of Positive Symptoms Scores (SAPS), Scale for the Assessment of Negative Symptoms Scores (SANS) and Positive And Negative Symptom Scale (PANSS) global score and Global Assessment of Functioning (GAF) score.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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low frequency (1Hz)

low frequency

Group Type ACTIVE_COMPARATOR

low frequency (1Hz)

Intervention Type PROCEDURE

10 session in 5 days with low frequency (1Hz)

Sham Comparator

Sham Comparator

Group Type SHAM_COMPARATOR

Sham Comparator

Intervention Type PROCEDURE

10 session in 5 days with sham-controlled

high frequency (20Hz)

high frequency

Group Type EXPERIMENTAL

high frequency (20Hz)

Intervention Type PROCEDURE

10 session in 5 days with high frequency (20 Hz)

Interventions

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high frequency (20Hz)

10 session in 5 days with high frequency (20 Hz)

Intervention Type PROCEDURE

low frequency (1Hz)

10 session in 5 days with low frequency (1Hz)

Intervention Type PROCEDURE

Sham Comparator

10 session in 5 days with sham-controlled

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with schizophrenia DSM IV-TR criteria and persistent AH resistant to antipsychotic treatments.

Exclusion Criteria

* Left handed patients lateralizes
* rTMS contraindications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline DUBERTRET, PU-PH

Role: STUDY_DIRECTOR

Department of Psychiatry, Louis MOURIER Hospital

Locations

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Department of Psychiatry, Louis Mourier Hospital

Colombes, , France

Site Status

Countries

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France

Other Identifiers

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IDRCB 2013-A00872-43

Identifier Type: OTHER

Identifier Source: secondary_id

P120909

Identifier Type: -

Identifier Source: org_study_id

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