Clinical trial NCT02175251: Low and High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Resistant Auditory Hallucination in Schizophrenia
Official title: Low and High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Resistant Auditory Hallucination in Schizophrenia: a Double Blind Sham-controlled Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: rTMS
Schizophrenia
high frequency rTMS
low frequency rTMS
AHRS
SAPS SANS PANSS
GAF
UKU
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Left handed patients lateralizes
* rTMS contraindications

Primary outcomes:
measure: 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.
timeFrame: 5 day
Secondary outcomes:
measure: To compare the efficiency of low frequency (1Hz) to sham-controlled condition repetitive Transcranial Magnetic Stimulation (rTMS) in term of Auditory Hallucination reduction.
timeFrame: 5 days
measure: To compare the efficiency of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.
timeFrame: 5 days
measure: To compare the maintenance of therapeutic effect for one month of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.
timeFrame: 1 month
measure: 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
timeFrame: 15 days 1 month, 2 months and 3 months
measure: To compare the side effects of each of the active treatment
timeFrame: at Inclusion and 5 day
Other outcomes:
Locations:
city: Colombes
country: France
facility: Department of Psychiatry, Louis Mourier Hospital
Study officials:
affiliation: Department of Psychiatry, Louis MOURIER Hospital
name: Caroline DUBERTRET, PU-PH
role: STUDY_DIRECTOR
References: