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

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ClinicalTrials.gov Identifier: NCT02175251
Recruitment Status : Unknown
Verified January 2018 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2014
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Procedure: high frequency (20Hz) Procedure: low frequency (1Hz) Procedure: Sham Comparator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2014
Actual Primary Completion Date : September 29, 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: low frequency (1Hz)
low frequency
Procedure: low frequency (1Hz)
10 session in 5 days with low frequency (1Hz)

Sham Comparator: Sham Comparator
Sham Comparator
Procedure: Sham Comparator
10 session in 5 days with sham-controlled

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 )



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175251


Locations
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France
Department of Psychiatry, Louis Mourier Hospital
Colombes, France, 92700
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Caroline DUBERTRET, PU-PH Department of Psychiatry, Louis MOURIER Hospital
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02175251    
Other Study ID Numbers: P120909
IDRCB 2013-A00872-43 ( Other Identifier: FRENCH AUTHORITY )
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
rTMS
Schizophrenia
high frequency rTMS
low frequency rTMS
AHRS
SAPS SANS PANSS
GAF
UKU
Additional relevant MeSH terms:
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Hallucinations
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms