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

September 7, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Colombes, France, 92700
        • Department of Psychiatry, Louis Mourier Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Left handed patients lateralizes
  • rTMS contraindications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
5 days
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)
5 days
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)
1 month
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
15 days 1 month, 2 months and 3 months
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 )
at Inclusion and 5 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Caroline DUBERTRET, PU-PH, Department of Psychiatry, Louis Mourier Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

July 7, 2017

Study Completion (Actual)

September 29, 2017

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimated)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P120909
  • IDRCB 2013-A00872-43 (Other Identifier: FRENCH AUTHORITY)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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