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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
high frequency (20Hz)
low frequency (1Hz)
Sham Comparator
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring rTMS, Schizophrenia, high frequency rTMS, low frequency rTMS, AHRS, SAPS SANS PANSS, GAF, UKU

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Left handed patients lateralizes
  • rTMS contraindications

Sites / Locations

  • Department of Psychiatry, Louis Mourier Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Experimental

Arm Label

low frequency (1Hz)

Sham Comparator

high frequency (20Hz)

Arm Description

low frequency

Sham Comparator

high frequency

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
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)
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
To compare the side effects of each of the active treatment
Tolerance assessed with the UDVALG of KLINISKE UNDERSOGELSER scale (UKU )

Full Information

First Posted
May 22, 2014
Last Updated
September 7, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02175251
Brief Title
Low and High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Resistant Auditory Hallucination in Schizophrenia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 7, 2017 (Actual)
Study Completion Date
September 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
rTMS, Schizophrenia, high frequency rTMS, low frequency rTMS, AHRS, SAPS SANS PANSS, GAF, UKU

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low frequency (1Hz)
Arm Type
Active Comparator
Arm Description
low frequency
Arm Title
Sham Comparator
Arm Type
Sham Comparator
Arm Description
Sham Comparator
Arm Title
high frequency (20Hz)
Arm Type
Experimental
Arm Description
high frequency
Intervention Type
Procedure
Intervention Name(s)
high frequency (20Hz)
Intervention Description
10 session in 5 days with high frequency (20 Hz)
Intervention Type
Procedure
Intervention Name(s)
low frequency (1Hz)
Intervention Description
10 session in 5 days with low frequency (1Hz)
Intervention Type
Procedure
Intervention Name(s)
Sham Comparator
Intervention Description
10 session in 5 days with sham-controlled
Primary Outcome Measure Information:
Title
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.
Description
Auditory Hallucinations improvement at 5-day was evaluate with AHRS (Auditory Hallucination Rating Scale) score
Time Frame
5 day
Secondary Outcome Measure Information:
Title
To compare the efficiency of low frequency (1Hz) to sham-controlled condition repetitive Transcranial Magnetic Stimulation (rTMS) in term of Auditory Hallucination reduction.
Description
Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)
Time Frame
5 days
Title
To compare the efficiency of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.
Description
Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)
Time Frame
5 days
Title
To compare the maintenance of therapeutic effect for one month of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.
Description
Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)
Time Frame
1 month
Title
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
Title
To compare the side effects of each of the active treatment
Description
Tolerance assessed with the UDVALG of KLINISKE UNDERSOGELSER scale (UKU )
Time Frame
at Inclusion and 5 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline DUBERTRET, PU-PH
Organizational Affiliation
Department of Psychiatry, Louis MOURIER Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychiatry, Louis Mourier Hospital
City
Colombes
ZIP/Postal Code
92700
Country
France

12. IPD Sharing Statement

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

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