rTMS Add on Value for Amelioration of Negative Symptoms of Schizophrenia (NCT04318977) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
rTMS Add on Value for Amelioration of Negative Symptoms of Schizophrenia
Czechia, Germany62 participantsStarted 2020-02-01
Plain-language summary
Treatment of depression with repetitive transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. The treatment of negative symptoms with the same protocol in schizophrenia is considered as possible effective. Theta burst stimulation is a new protocol which is characterized by shorter sessions showing first evidence that it's efficacy is comparable to the high-frequency rTMS. In this randomized placebo-controlled study the efficacy of high-frequency rTMS and TBS are evaluated.
Who can participate
Age range
18 Years – 75 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:
* ICD-10: schizophrenia with primarily negative symptoms
* Age: 18-75 years
* at least 35 Points at the composite score of the SANS
* stabe medication during the last 2 weeks (at the investigator's discretion)
* written informed consent (by the patient or guardian)
Exclusion Criteria:
* clinically relevant unstable concomitant somatic diseases
* previous treatment by rTMS
* conditions in which TMS may not be applicated, as e.g., cardiac pacemakers or ferromagnetic implants
* history of epileptic seizures
* current substance or alcohol abuse, or clinically relevant comorbidity (according to M.I.N.I. interview)
* unacceptable concomitant medication (benzodiazepines in higher doses, e.g., Lorazepam \> 2 mg/d, Diazepam \> 10 mg/d)
* insufficient knowledge of the language of the country of the treatment site
* pregnancy and nursing period
* current statutory hospitalisation
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
Scale for the Assessement of Negative Symptoms (SANS)