SchizophreniaHRRENATNCT06599372
Evaluation of the Efficacy of Transcranial Magnetic Stimulation on Resistant Auditory Hallucinations in Schizophrenia
A study testing The rTMS method and The cTBS method in people with Schizophrenia and Transcranial Magnetic Stimulation, run by Dominique JANUEL at 1 site in France.
Trial summary
This open naturalistic study aims to evaluate the efficacy of rTMS in routine practice on auditory resistant hallucinations (AHR) of patients with schizophrenia. To this end, two stimulation methods will be offered to patients: the rTMS stimulation method and the cTBS stimulation method.We principally use the AHRS… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Transcranial Magnetic Stimulation, Hallucinations, Verbal Auditory
- What is being tested?
- The rTMS method and The cTBS method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2022to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient over 18 years of age
- Patient diagnosed with schizophrenia according to DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
- Presence of auditory hallucinations: Resistant auditory hallucinations: resistance to treatment with 2 different well-conducted antipsychotics.
- Patient agreeing to participate in the study and having signed an informed consent
- Patient with French language skills
- Affiliation to a social security system
- Women of childbearing age must be on contraception and have a negative pregnancy test (βHCG)
Who cannot join
- Have a contraindication to MST: intracranial foreign body, unstabilized epilepsy, cochlear implant
- Presence of an unstabilized medical condition
- Pregnant woman (Women of childbearing age without effective contraception)
- Current or less than one month old engagement in another research protocol
- A person who is subject to a safeguard of justice measure
- An adult under curatorship
Show all 10Show fewer
- Minor patients with mental health problems
- Pregnant or breastfeeding women
- A person in a social fragility (Persons deprived of liberty by a judicial or administrative decision, hospitalized persons)
- Persons incapable or unable to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Etablissement Public de Santé de Ville-Evrard
Neuilly-sur-Marne, 93330
Youcef Bencherif, +33 1 43 09 32 32, urcve1@gmail.com
Rusheentira Thavaseelan, +33 1 43 09 32 32, urcve1@gmail.com
About this study
Official title: Treatment of Resistant Auditory Hallucinations in Schizophrenia by Repetitive Transcranial Magnetic Stimulation. Naturalistic Study
This open naturalistic study aims to evaluate the efficacy of rTMS in routine practice on auditory resistant hallucinations (AHR) of patients with schizophrenia. To this end, two stimulation methods will be offered to patients: the rTMS stimulation method and the cTBS stimulation method.We principally use the AHRS scale to evaluate the effectiveness of rTMS on RAH in patients with schizophrenia. Our main hypothesis is that rTMS used under naturalistic conditions, in addition to antipsychotics, would allow a relative improvement of resistant auditory hallucinations assessed by the AHRS scale between baseline and end of treatment in patients with schizophrenia.
- Being tested
- The rTMS method, The cTBS method
- Keywords
- hallucinations, resistant auditory hallucinations, schizophrenia, TMS, Transcranial magnetic stimulation, TBS, Theta burst stimulation, a improvement, real-life conditions
- Medical subject headings
- Schizophrenia, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The rTMS methodOther
The patient receives treatment under naturalistic conditions in routine practice.
The cTBS methodOther
The patient receives the treatment under naturalistic conditions in routine practice.
| Study group | Role | What they receive |
|---|---|---|
| The rTMS method | Other | The treatment lasts 2 weeks with 20 rTMS sessions at a rate of 2 sessions per day. Each session lasts 20 minutes with a one hour break between sessions. The application of rTMS will be done on the left temporo-parietal junction. Receives: Other: The rTMS method |
| The cTBS method | Other | The treatment lasts 15 days with 45 sessions of cTBS at a rate of 3 sessions per day. The session lasts 40 seconds and consists of 3 pulses at 50Hz repeated every 200 milliseconds (5Hz) to reach a total of 600 pulses, with a 15 minute break between sessions. The application of cTBS will be performed on the left temporo-parietal junction. Receives: Other: The cTBS method |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evolution will be evaluated mainly with the AHRS (Auditory Hallucinations Rating Scale)
Refer to the definition of AHRS above (in Primary Outcome Measure)
Measured: Baseline and at the end of the treatment, also at 1 month and 3 months after the end of the treatment
Secondary outcomes (7)
Response rate: a response is defined as a decrease greater than or equal to 30% of total AHRS score from baseline to end of treatment.
Refer to the definition of AHRS above
Measured: Baseline and at the end of the treatment
Rate of patients with an end-of-treatment score < 3 on the Positive And Negative Syndrome Scale (PANSS) "Hallucinatory Behavior" item
The PANSS is a 30 items scale rated from 1 (absent) to 7 (extreme), that assesses psychopathological symptoms observed in patients with psychotic states, particularly schizophrenia.
Measured: Baseline and at the end of the treatment
Cognitive symptoms: Montreal Cognitive Assessment (MOCA), Stroop
The MoCA scale is the most sensitive rapid assessment test and provides the broadest evaluation of cognitive functions (attention, concentration, executive functions, memory, language, visualconstructive abilities, abstraction, calculation, orientation). It tends to replace the MMSE in clinical practice. A score < 26 (25 if cultural level < 3 = primary diploma = CEP) is considered abnormal. The Stroop scale evaluates the capacity for attention and inhibition; thus, it allows to measure the level of interference generated by the automatisms in the accomplishment of a task. The result of the test allows us to see if the person is correctly inhibiting the response (values greater than 0, positive) or if there are significant interference problems (if it is a negative value).
Measured: Baseline and 1 month after the end of treatment
Addictive attitudes: number of cigarettes/d (tobacco), The Cannabis Abuse Screening Test (CAST), Marijuana Craving Questionnaire (MCQ)
The CAST is a 6-item scale for identifying problematic cannabis use. Each of these items describes use behaviors or problems encountered with cannabis use. The CAST score determines the patient's level of dependence. A score of 1 or less means low risk. A score of 2 means moderate risk. A score of 3 or higher means high risk. The MCQ self-report scale is a questionnaire on marijuana craving. It consists of four constructs or factors that characterize cannabis craving: compulsivity, emotionality, expectancy and determination. A separate score is calculated for each factor. The MCQ can be used to measure cue-induced craving in a research setting or natural craving in cannabis-dependent individuals presenting for treatment.
Measured: Baseline and at the end of the treatment
Mood: Calgary Depression Scale for Schizophrenia (CDSS)
The CDSS, is designed to assess depression in people with schizophrenia. It takes into account negative symptomatology and possible extrapyramidal effects of neuroleptics. The questionnaire consists of 9 items covering the last 2 weeks. Each item is evaluated on a 4 points Likert scale ranging from : "Absent" (0) to "Severe" (3). The total score is obtained by adding the items and gives a score out of 27.
Measured: Baseline and the end of the treatment
Quality of life: The Subjective Quality of Life Scale (S-QoL)
The SQoL questionnaire is a self-administered quality of life scale that assesses quality of life in people with schizophrenia from the patient's perspective. The questionnaire has 18 items, each item is rated on a 4 points Likert scale ranging from: "Much less" to "More than desired". Scores range from 0 to 100; higher scores represent better quality of life.
Measured: Baseline and end of treatment, also at 1 month and 3 months after the end of the treatment
Clinical Global Impressions (CGI) Scale
Clinical Global Impression (CGI) scales are measures of symptom severity, response to treatment, and treatment effectiveness in treatment studies of patients with mental disorders.
Measured: Baseline and end of treatment, also at 1 month and 3 months after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start11 Jul 2022
- Primary completionJul 2027 (estimated)
- Study completionNov 2027 (estimated)
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dominique JANUEL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dominique JANUEL, Centre hospitalier de Ville-Evrard, France
- Investigators
- Dominique JANUEL, Study director, Clinical research unit, EPS Ville EvrardNoomane BOUAZIZ, Principal investigator, Clinical research unit, EPS Ville Evrard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599372
- Sponsor's protocol ID
- 2021-A02698-33
- Acronym
- HRRENAT
- Status last verified
- Sep 2024
- First submitted
- 24 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Resistant Auditory Hallucinations in Schizophrenia by Repetitive Transcranial Magnetic Stimulation. Naturalistic Study
- ClinicalTrials.gov ID
- NCT06599372
- Acronym / sponsor ID
- HRRENAT / 2021-A02698-33
- Keywords
- hallucinations, resistant auditory hallucinations, schizophrenia, TMS, Transcranial magnetic stimulation, TBS, Theta burst stimulation, a improvement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dominique JANUELUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
This open naturalistic study aims to evaluate the efficacy of rTMS in routine practice on auditory resistant hallucinations (AHR) of patients with schizophrenia. To this end, two stimulation methods will be offered to patients: the rTMS stimulation method and the cTBS stimulation method.We principally use the AHRS scale to evaluate the effectiveness of rTMS on RAH in patients with schizophrenia. Our main hypothesis is that rTMS used under naturalistic conditions, in addition to antipsychotics, would allow a relative improvement of resistant auditory hallucinations assessed by the AHRS scale between baseline and end of treatment in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The rTMS method | Other | Other: The rTMS methodThe treatment lasts 2 weeks with 20 rTMS sessions at a rate of 2 sessions per day. Each session lasts 20 minutes with a one hour break between sessions. The application of rTMS will be done on the left temporo-parietal junction. |
| The cTBS method | Other | Other: The cTBS methodThe treatment lasts 15 days with 45 sessions of cTBS at a rate of 3 sessions per day. The session lasts 40 seconds and consists of 3 pulses at 50Hz repeated every 200 milliseconds (5Hz) to reach a total of 600 pulses, with a 15 minute break between sessions. The application of cTBS will be performed on the left temporo-parietal junction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient over 18 years of age
- Patient diagnosed with schizophrenia according to DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
- Presence of auditory hallucinations: Resistant auditory hallucinations: resistance to treatment with 2 different well-conducted antipsychotics.
- Patient agreeing to participate in the study and having signed an informed consent
- Patient with French language skills
Key exclusion criteria (10 listed)
- Have a contraindication to MST: intracranial foreign body, unstabilized epilepsy, cochlear implant
- Presence of an unstabilized medical condition
- Pregnant woman (Women of childbearing age without effective contraception)
- Current or less than one month old engagement in another research protocol
- A person who is subject to a safeguard of justice measure
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 |
|---|---|---|
| The rTMS methodThe patient receives treatment under naturalistic conditions in routine practice. | Other | The rTMS method |
| The cTBS methodThe patient receives the treatment under naturalistic conditions in routine practice. | Other | The cTBS method |
Primary outcome
The evolution will be evaluated mainly with the AHRS (Auditory Hallucinations Rating Scale)
Time frame: Baseline and at the end of the treatment, also at 1 month and 3 months after the end of the treatment
Refer to the definition of AHRS above (in Primary Outcome Measure)
7 secondary outcomes
Response rate: a response is defined as a decrease greater than or equal to 30% of total AHRS score from baseline to end of treatment.
Time frame: Baseline and at the end of the treatment
Rate of patients with an end-of-treatment score < 3 on the Positive And Negative Syndrome Scale (PANSS) "Hallucinatory Behavior" item
Time frame: Baseline and at the end of the treatment
Cognitive symptoms: Montreal Cognitive Assessment (MOCA), Stroop
Time frame: Baseline and 1 month after the end of treatment
Addictive attitudes: number of cigarettes/d (tobacco), The Cannabis Abuse Screening Test (CAST), Marijuana Craving Questionnaire (MCQ)
Time frame: Baseline and at the end of the treatment
Mood: Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: Baseline and the end of the treatment
Quality of life: The Subjective Quality of Life Scale (S-QoL)
Time frame: Baseline and end of treatment, also at 1 month and 3 months after the end of the treatment
Clinical Global Impressions (CGI) Scale
Time frame: Baseline and end of treatment, also at 1 month and 3 months after the end of the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Dominique JANUEL study director
Clinical research unit, EPS Ville Evrard
Noomane BOUAZIZ principal investigator
Clinical research unit, EPS Ville Evrard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The rTMS method and The cTBS method in people with Schizophrenia and Transcranial Magnetic Stimulation, run by Dominique JANUEL 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youcef Bencherif (+33 1 43 09 32 32, urcve1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evolution will be evaluated mainly with the AHRS (Auditory Hallucinations Rating Scale) (time frame: Baseline and at the end of the treatment, also at 1 month and 3 months after the end of the treatment). 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 19 Sep 2024.