SchizophreniaSN RENATNCT06595654
Treatment of Negative Symptoms of Schizophrenia by rTMS
A study testing repetitive Transcranial Magnetic Stimulation in people with Schizophrenia and Negative Symptoms in Schizophrenia, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
Trial summary
The purpose of this study is to assess the effectiveness of rTMS on the negative symptoms of schizophrenia in real conditions. It will also provide a regulatory framework to rTMS treatments under these conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Negative Symptoms in Schizophrenia
- What is being tested?
- repetitive Transcranial Magnetic Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2023to Mar 2028
- 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 the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
- Stable drug treatment for at least 4 weeks
- Presence or persistence of negative symptoms in the foreground:
- Negative PANSS score ⩾21, positive PANSS score ⩽24
- Patient (or legal representative) willing to participate in the study and having signed an informed consent
- Patient fluent in the French language
- Affiliation to a social security scheme
Who cannot join
- Present a contraindication to TMS: intracranial foreign body, unstabilized epilepsy, cochlear implant, pace-maker
- Presence of an unstabilized medical condition
- Pregnant woman
- Woman of childbearing potential and without effective contraception
- Breastfeeding woman
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 Negative Symptoms of Schizophrenia by Repetitive Transcranial Magnetic Stimulation: A Naturalistic Study
The purpose of this study is to assess the effectiveness of rTMS on the negative symptoms of schizophrenia in real conditions. It will also provide a regulatory framework to rTMS treatments under these conditions. 4 types of rTMS protocols are proposed, allowing to adapt to patients and their tolerances.Treatment lasts between 2 and 4 weeks, with a follow-up period of 3 months after treatment to observe relapses.To assess the evolution of negative symptoms between baseline and the end of treatment, investigators use SANS (Scale for the Assessment of Negative Symptoms).
- Conditions
- Schizophrenia, Negative Symptoms in Schizophrenia
- Being tested
- repetitive Transcranial Magnetic Stimulation
- Keywords
- rTMS, TMS, Transcranial magnetic stimulation, naturalistic
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic StimulationOther
- Patient is in a chair.
- Hearing protection will be implemented.
- The corresponding targeting method will be implemented.
- The stimulation coil will be set up according to the indications of the targeting method.
- A caregiver is present throughout the session.
- After the session, the patient is re-assessed clinically for possible adverse effects.
- If an adverse reaction is objectified, a doctor on site, is quickly mobilized.
| Study group | Role | What they receive |
|---|---|---|
| Method 1 | Other | One stimulation session per day for 20 working days, so 4 weeks (frequency of 10 Hz, 80% 100% of motor threshold). Each session lasts 20 min. The duration of the train is 4 s, an inter-train of 56s. Receives: Other: repetitive Transcranial Magnetic Stimulation |
| Method 2 | Other | Two stimulations sessions per day, with 1 hour apart, for 20 working days, so 4 weeks (frequency of 20 Hz, 100% of motor threshold).Each session lasts 28 min. The duration of the train of 10 s, an inter-train of 80s The total number of pulses is 40000 in 20 trains or 2000 per day. Receives: Other: repetitive Transcranial Magnetic Stimulation |
| Method 3 | Other | Two stimulations session per day for 10 working days, so 2 weeks. The protocol is delivered in bursts containing 3 pulses at 50 Hz repeated at 200 ms intervals for 2 s (i.e., 5 Hz). Stimulation intensity is set at 80% of the idle motor threshold intensity Receives: Other: repetitive Transcranial Magnetic Stimulation |
| Method 4 | Other | Five to ten sessions per day, 50 minutes apart, with 90% SM for 10 working days, so 2 weeks. 1 of stimuli every 20 ms (50Hz) repeated 3 times, this train itself repeated every 200 ms (5 Hz) or 60 cycles of 10 blocks of 3 stimuli. The duration of the train is 2 seconds with an inter-train of 8 seconds. So there are 1800 stimuli per session Receives: Other: repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efectiveness of rTMS on the negative symptoms of schizophrena, assessed by the SANS ( Scale Assessment Negative Symptoms).
The SANS is a scale used for negative symptoms that is initially made up of 19 items divided into five sub-scales: emotional blunder, pedigree, avolition-apathy, anhedonia and social withdrawal. Based on the percentage reduction of this score after 2-4 weeks, patients will be allocated according to the following criteria:
- Remission: 75%
- Effective treatment: 50-74%
- Improvement/response: 25-49%
- No answer: <25%
Measured: Baseline (day 1) to end of treatment (2 or 4 weeks)
Secondary outcomes (9)
Evaluate the impact of this treatment on general psychopathology assessed by PANSS and CGI.
The PANSS (Positive and Negative Syndrome Scale) is composed of 3 parts: positive symptoms, negative symptoms and general psychopathology. The last part consists of 16 items. The score can range from 16 to 112. The CGI (Clinical Global Impression) is a 3-item scale: the severity of the disease, the overall improvement and the efficiency index. The first two items are scored from 0 to 7, and the last in a 4x4 table.
Measured: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.
Assess the impact of this treatment on response rate by the SANS
The Scale for the Assessment of Negative Symptoms (SANS) splits assessment into five domains (Affective flattening, Alogia, Avolition, Anhedonia, Attention). Within each domain it rates separate symptoms from 0 (absent) to 5 (severe). The response is defined by a 25-49% reduction in the initial score.
Measured: Baseline (day 1) to end of treatment (2 or 4 weeks)
Assess the impact of this treatment on the rate of remission by the number of remission with the SANS
The Scale for the Assessment of Negative Symptoms (SANS) splits assessment into five domains (Affective flattening, Alogia, Avolition, Anhedonia, Attention). Within each domain it rates separate symptoms from 0 (absent) to 5 (severe). Based on the percentage reduction of this score after 2-4 weeks, patients will be considered in remission if they have a 75% reduction..
Measured: Baseline (day 1) to end of treatment (2 or 4 weeks)
Assess the impact of this treatment on the relapse rate by the number of relapse with SANS
The SANS is a scale used for negative symptoms that is initially made up of 19 items divided into five sub-scales: emotional blunder, pedigree, avolition-apathy, anhedonia and social withdrawal. Based on the percentage reduction of this score after 2-4 weeks, patients will be allocated according to the following criteria:
- Remission: 75%
- Effective treatment: 50-74%
- Improvement/response: 25-49%
- No answer: <25%
Measured: 4 weeks, 12 weeks and 24 weeks after the end of treatment.
Assess the impact of this treatment on cognitive symptoms by MOCA (Montreal Cognitive Assessment) and 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). 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 (day 1) to end of treatment (2 or 4 weeks)
Assess the impact of this treatment on addictive attitudes by MCQ (Marijuana Craving Questionnaire) and CAST (Cannabis Abuse Screening Test)
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 (day 1) to end of treatment (2 or 4 weeks)
Assess the impact of this treatment on mood by CDSS (Calgary Depression Scale for Schizophrenia).
The CDSS, is designed to assess depression in people with schizophrenia. . 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 (day 1) to end of treatment (2 or 4 weeks)
Assess the impact of this treatment on quality of life by S-QoL-18
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 (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.
Assess the impact of this treatment on adverse reactions by the CGI
The CGI (Clinical Global Impression) is a 3-item scale: the severity of the disease, the overall improvement and the efficiency index. The first two items are scored from 0 to 7, and the last in a 4x4 table. The last item allows a combined measurement of the main clinical effect and side effects.
Measured: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of 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 start9 Jun 2023
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominique JANUEL, Centre hospitalier de Ville-Evrard, France
- Investigators
- Dominique Januel, Principal investigator, Clinical research unit, EPS Ville Evrard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595654
- Sponsor's protocol ID
- 2021-A02710-40
- Acronym
- SN RENAT
- 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
- Individual data sharing
- 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 Negative Symptoms of Schizophrenia by Repetitive Transcranial Magnetic Stimulation: A Naturalistic Study
- ClinicalTrials.gov ID
- NCT06595654
- Acronym / sponsor ID
- SN RENAT / 2021-A02710-40
- Conditions
- Schizophrenia, Negative Symptoms in Schizophrenia
- Keywords
- rTMS, TMS, Transcranial magnetic stimulation, naturalistic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (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.
The purpose of this study is to assess the effectiveness of rTMS on the negative symptoms of schizophrenia in real conditions. It will also provide a regulatory framework to rTMS treatments under these conditions. 4 types of rTMS protocols are proposed, allowing to adapt to patients and their tolerances.Treatment lasts between 2 and 4 weeks, with a follow-up period of 3 months after treatment to observe relapses.To assess the evolution of negative symptoms between baseline and the end of treatment, investigators use SANS (Scale for the Assessment of Negative Symptoms).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Method 1 | Other | Other: repetitive Transcranial Magnetic StimulationOne stimulation session per day for 20 working days, so 4 weeks (frequency of 10 Hz, 80% 100% of motor threshold). Each session lasts 20 min. The duration of the train is 4 s, an inter-train of 56s. |
| Method 2 | Other | Other: repetitive Transcranial Magnetic StimulationTwo stimulations sessions per day, with 1 hour apart, for 20 working days, so 4 weeks (frequency of 20 Hz, 100% of motor threshold).Each session lasts 28 min. The duration of the train of 10 s, an inter-train of 80s The total number of pulses is 40000 in 20 trains or 2000 per day. |
| Method 3 | Other | Other: repetitive Transcranial Magnetic StimulationTwo stimulations session per day for 10 working days, so 2 weeks. The protocol is delivered in bursts containing 3 pulses at 50 Hz repeated at 200 ms intervals for 2 s (i.e., 5 Hz). Stimulation intensity is set at 80% of the idle motor threshold intensity |
| Method 4 | Other | Other: repetitive Transcranial Magnetic StimulationFive to ten sessions per day, 50 minutes apart, with 90% SM for 10 working days, so 2 weeks. 1 of stimuli every 20 ms (50Hz) repeated 3 times, this train itself repeated every 200 ms (5 Hz) or 60 cycles of 10 blocks of 3 stimuli. The duration of the train is 2 seconds with an inter-train of 8 seconds. So there are 1800 stimuli per session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient over 18 years of age
- Patient diagnosed with schizophrenia according to the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
- Stable drug treatment for at least 4 weeks
- Presence or persistence of negative symptoms in the foreground:
- Negative PANSS score ⩾21, positive PANSS score ⩽24
Key exclusion criteria (5 listed)
- Present a contraindication to TMS: intracranial foreign body, unstabilized epilepsy, cochlear implant, pace-maker
- Presence of an unstabilized medical condition
- Pregnant woman
- Woman of childbearing potential and without effective contraception
- Breastfeeding woman
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 |
|---|---|---|
| repetitive Transcranial Magnetic Stimulation* Patient is in a chair. * Hearing protection will be implemented. * The corresponding targeting method will be implemented. * The stimulation coil will be set up according to the indications of the targeting method. * A caregiver is present throughout the session. * After the session, the patient is re-assessed clinically for possible adverse effects. * If an adverse reaction is objectified, a doctor on site, is quickly mobilized. | Other | Method 1, Method 2, Method 3, Method 4 |
Primary outcome
Evaluate the efectiveness of rTMS on the negative symptoms of schizophrena, assessed by the SANS ( Scale Assessment Negative Symptoms).
Time frame: Baseline (day 1) to end of treatment (2 or 4 weeks)
The SANS is a scale used for negative symptoms that is initially made up of 19 items divided into five sub-scales: emotional blunder, pedigree, avolition-apathy, anhedonia and social withdrawal. Based on the percentage reduction of this score after 2-4 weeks, patients will be allocated according to the following criteria: * Remission: 75% * Effective treatment: 50-74% * Improvement/response: 25-49% * No answer: <25%
9 secondary outcomes
Evaluate the impact of this treatment on general psychopathology assessed by PANSS and CGI.
Time frame: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.
Assess the impact of this treatment on response rate by the SANS
Time frame: Baseline (day 1) to end of treatment (2 or 4 weeks)
Assess the impact of this treatment on the rate of remission by the number of remission with the SANS
Time frame: Baseline (day 1) to end of treatment (2 or 4 weeks)
Assess the impact of this treatment on the relapse rate by the number of relapse with SANS
Time frame: 4 weeks, 12 weeks and 24 weeks after the end of treatment.
Assess the impact of this treatment on cognitive symptoms by MOCA (Montreal Cognitive Assessment) and STROOP
Time frame: Baseline (day 1) to end of treatment (2 or 4 weeks)
Assess the impact of this treatment on addictive attitudes by MCQ (Marijuana Craving Questionnaire) and CAST (Cannabis Abuse Screening Test)
Time frame: Baseline (day 1) to end of treatment (2 or 4 weeks)
Assess the impact of this treatment on mood by CDSS (Calgary Depression Scale for Schizophrenia).
Time frame: Baseline (day 1) to end of treatment (2 or 4 weeks)
Assess the impact of this treatment on quality of life by S-QoL-18
Time frame: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.
Assess the impact of this treatment on adverse reactions by the CGI
Time frame: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of 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.
- Individual participant dataSharing planned: No
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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 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 repetitive Transcranial Magnetic Stimulation in people with Schizophrenia and Negative Symptoms in Schizophrenia, run by Centre hospitalier de Ville-Evrard, France 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 8 inclusion and 5 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, urc@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efectiveness of rTMS on the negative symptoms of schizophrena, assessed by the SANS ( Scale Assessment Negative Symptoms). (time frame: Baseline (day 1) to end of treatment (2 or 4 weeks)). 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.