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NCT Number: NCT02175251

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Louis Mourier Hospital

Colombes, 92700, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Left handed patients lateralizes
  • rTMS contraindications

Treatment and study plan

high frequency (20Hz)

Procedure

10 session in 5 days with high frequency (20 Hz)

low frequency (1Hz)

Procedure

10 session in 5 days with low frequency (1Hz)

Sham Comparator

Procedure

10 session in 5 days with sham-controlled

Primary outcomes

  1. 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.

    Time frame: 5 day

    Auditory Hallucinations improvement at 5-day was evaluate with AHRS (Auditory Hallucination Rating Scale) score

Secondary outcomes

  1. To compare the efficiency of low frequency (1Hz) to sham-controlled condition repetitive Transcranial Magnetic Stimulation (rTMS) in term of Auditory Hallucination reduction.

    Time frame: 5 days

    Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)

  2. To compare the efficiency of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.

    Time frame: 5 days

    Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)

  3. To compare the maintenance of therapeutic effect for one month of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.

    Time frame: 1 month

    Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)

  4. 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

    Time frame: 15 days 1 month, 2 months and 3 months

  5. To compare the side effects of each of the active treatment

    Time frame: at Inclusion and 5 day

    Tolerance assessed with the UDVALG of KLINISKE UNDERSOGELSER scale (UKU )

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: rTMS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 26, 2014
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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