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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Schizophrenia

Treatments: Procedure: Sham Comparator; Procedure: low frequency (1Hz); Procedure: high frequency (20Hz)

Study type: Interventional

Funder types: Other

Identifiers

NCT02175251

P120909

IDRCB 2013-A00872-43 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Left handed patients lateralizes
• rTMS contraindications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 3 patient groups

low frequency (1Hz)

Active Comparator group

Description:

low frequency

Treatment:

Procedure: low frequency (1Hz)

Sham Comparator

Sham Comparator group

Description:

Sham Comparator

Treatment:

Procedure: Sham Comparator

high frequency (20Hz)

Experimental group

Description:

high frequency

Treatment:

Procedure: high frequency (20Hz)