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

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Procedure: low frequency (1Hz); Procedure: Sham Comparator; Procedure: high frequency (20Hz)

• Registration Number: NCT02175251
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-26
• Primary Completion: 2017-07-07
• Study Completion: 2017-09-29
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

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

Exclusion Criteria

• Left handed patients lateralizes
• rTMS contraindications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low frequency (1Hz)	low frequency (1Hz)	low frequency
Sham Comparator	Sham Comparator	Sham Comparator
high frequency (20Hz)	high frequency (20Hz)	high frequency

Primary Outcome Measures

Name	Time	Method
To evaluate the efficiency of high frequency (20Hz) repetitive Transcranial Magnetic Stimulation (rTMS) to the left temporoparietal cortex compared to sham controlled condition rTMS in term on Auditory Hallucinations reduction.	5 day	Auditory Hallucinations improvement at 5-day was evaluate with AHRS (Auditory Hallucination Rating Scale) score

Secondary Outcome Measures

Name	Time	Method
To compare the efficiency of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.	5 days	Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)
To evaluate the maintenance of therapeutic effect of high frequency compared to sham controlled condition for 15 days 1 month, 2 months and 3 months	15 days 1 month, 2 months and 3 months
To compare the efficiency of low frequency (1Hz) to sham-controlled condition repetitive Transcranial Magnetic Stimulation (rTMS) in term of Auditory Hallucination reduction.	5 days	Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)
To compare the side effects of each of the active treatment	at Inclusion and 5 day	Tolerance assessed with the UDVALG of KLINISKE UNDERSOGELSER scale (UKU )
To compare the maintenance of therapeutic effect for one month of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.	1 month	Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)

Trial Locations

Locations (1)

Department of Psychiatry, Louis Mourier Hospital; 🇫🇷 Colombes, France