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

Schizophrenia Clinical Trial

— rTMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175251
• Other study ID #: P120909
• Secondary ID: IDRCB 2013-A0087
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: September 29, 2017

Study information

• Verified date: September 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 29, 2017
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Left handed patients lateralizes

• rTMS contraindications

Related Conditions & MeSH terms

• Hallucinations
• Schizophrenia

Intervention

Procedure:
• high frequency (20Hz)
10 session in 5 days with high frequency (20 Hz)
• low frequency (1Hz)
10 session in 5 days with low frequency (1Hz)
• Sham Comparator
10 session in 5 days with sham-controlled

Locations

Country	Name	City	State
France	Department of Psychiatry, Louis Mourier Hospital	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Auditory Hallucinations improvement at 5-day was evaluate with AHRS (Auditory Hallucination Rating Scale) score	5 day
Secondary	To compare the efficiency of low frequency (1Hz) to sham-controlled condition repetitive Transcranial Magnetic Stimulation (rTMS) in term of Auditory Hallucination reduction.	Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)	5 days
Secondary	To compare the efficiency of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.	Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)	5 days
Secondary	To compare the maintenance of therapeutic effect for one month of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.	Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)	1 month
Secondary	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
Secondary	To compare the side effects of each of the active treatment	Tolerance assessed with the UDVALG of KLINISKE UNDERSOGELSER scale (UKU )	at Inclusion and 5 day