An interventional study of The rTMS method and The cTBS method in Schizophrenia, Transcranial Magnetic Stimulation and Hallucinations, Verbal Auditory, sponsored by Dominique JANUEL. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Dominique JANUEL · Not applicable, Interventional, and Treatment
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 30 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Dominique JANUEL is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: The rTMS method
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.
Other: The cTBS method
The patient receives treatment under naturalistic conditions in routine practice.
The patient receives the treatment under naturalistic conditions in routine practice.
The evolution will be evaluated mainly with the AHRS (Auditory Hallucinations Rating Scale)
Refer to the definition of AHRS above (in Primary Outcome Measure)
Time frame: Baseline and at the end of the treatment, also at 1 month and 3 months after the end of the treatment
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
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
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.
Time frame: 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).
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)
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.
Time frame: 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.
Time frame: 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.
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
Clinical Global Impression (CGI) scales are measures of symptom severity, response to treatment, and treatment effectiveness in treatment studies of patients with mental disorders.
Time frame: Baseline and end of treatment, also at 1 month and 3 months after the end of the treatment
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Dominique JANUEL