Schizophrenia
Conditions
Keywords
rTMS, Schizophrenia, high frequency rTMS, low frequency rTMS, AHRS, SAPS SANS PANSS, GAF, UKU
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.
Interventions
PROCEDURElow frequency (1Hz)
10 session in 5 days with low frequency (1Hz)
PROCEDURESham Comparator
10 session in 5 days with sham-controlled
PROCEDUREhigh frequency (20Hz)
10 session in 5 days with high frequency (20 Hz)
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with schizophrenia DSM IV-TR criteria and persistent AH resistant to antipsychotic treatments.
Exclusion criteria
* Left handed patients lateralizes * rTMS contraindications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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) |
| 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 side effects of each of the active treatment | at Inclusion and 5 day | Tolerance assessed with the UDVALG of KLINISKE UNDERSOGELSER scale (UKU ) |
Countries
France
Outcome results
None listed