Evaluation of the Efficacy of Transcranial Magnetic Stimulation on Resistant Auditory Hallucinati… (NCT06599372) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Efficacy of Transcranial Magnetic Stimulation on Resistant Auditory Hallucinations in Schizophrenia
France30 participantsStarted 2022-07-11
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The evolution will be evaluated mainly with the AHRS (Auditory Hallucinations Rating Scale)
Timeframe: Baseline and at the end of the treatment, also at 1 month and 3 months after the end of the treatment