SchizophreniarTMSNCT02175251
Low and High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Resistant Auditory Hallucination in Schizophrenia
A study testing high frequency (20Hz) and low frequency (1Hz) in people with Schizophrenia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- high frequency (20Hz) and low frequency (1Hz)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to 29 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with schizophrenia DSM IV-TR criteria and persistent AH resistant to antipsychotic treatments.
Who cannot join
- Left handed patients lateralizes
- rTMS contraindications
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- high frequency (20Hz), low frequency (1Hz), Sham Comparator
- Keywords
- rTMS, Schizophrenia, high frequency rTMS, low frequency rTMS, AHRS, SAPS SANS PANSS, GAF, UKU
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high frequency (20Hz)Procedure or surgery
10 session in 5 days with high frequency (20 Hz)
low frequency (1Hz)Procedure or surgery
10 session in 5 days with low frequency (1Hz)
Sham ComparatorProcedure or surgery
10 session in 5 days with sham-controlled
| Study group | Role | What they receive |
|---|---|---|
| low frequency (1Hz) | Active comparator | low frequency Receives: Procedure: low frequency (1Hz) |
| Sham Comparator | Sham comparator | Sham Comparator Receives: Procedure: Sham Comparator |
| high frequency (20Hz) | Experimental | high frequency Receives: Procedure: high frequency (20Hz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 day
Secondary outcomes (5)
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)
Measured: 5 days
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)
Measured: 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.
Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)
Measured: 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
Measured: 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 )
Measured: at Inclusion and 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completion7 Jul 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline DUBERTRET, PU-PH, Study director, Department of Psychiatry, Louis MOURIER Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175251
- Sponsor's protocol ID
- P120909
- Other IDs
- IDRCB 2013-A00872-43
- Acronym
- rTMS
- Status last verified
- Sep 2023
- First submitted
- 22 May 2014
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02175251
- Acronym / sponsor ID
- rTMS / P120909
- Conditions
- Schizophrenia
- Keywords
- rTMS, Schizophrenia, high frequency rTMS, low frequency rTMS, AHRS, SAPS SANS PANSS, GAF, UKU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low frequency (1Hz) | Active comparator | Procedure: low frequency (1Hz)low frequency |
| Sham Comparator | Sham comparator | Procedure: Sham ComparatorSham Comparator |
| high frequency (20Hz) | Experimental | Procedure: high frequency (20Hz)high frequency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with schizophrenia DSM IV-TR criteria and persistent AH resistant to antipsychotic treatments.
Key exclusion criteria (2 listed)
- Left handed patients lateralizes
- rTMS contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high frequency (20Hz)10 session in 5 days with high frequency (20 Hz) | Procedure or surgery | high frequency (20Hz) |
| low frequency (1Hz)10 session in 5 days with low frequency (1Hz) | Procedure or surgery | low frequency (1Hz) |
| Sham Comparator10 session in 5 days with sham-controlled | Procedure or surgery | Sham Comparator |
Primary outcome
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 secondary outcomes
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
To compare the efficiency of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.
Time frame: 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
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
To compare the side effects of each of the active treatment
Time frame: at Inclusion and 5 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline DUBERTRET, PU-PH study director
Department of Psychiatry, Louis MOURIER Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high frequency (20Hz) and low frequency (1Hz) in people with Schizophrenia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.