TerminatedNot Applicable

Accelerated rTMS for Psychomotor Slowing

Stopped: Planned interim analyses demonstrated that the main aim of the study was already met. Recruitment was stopped. Early termination was unrelated to safety.

Switzerland25 participantsStarted 2023-09-22

Plain-language summary

The goal of this clinical trial is to optimize the treatment of psychomotor slowing in patients with schizophrenia using Transcranial Magnetic Stimulation (TMS). A previous randomized controlled trial indicated that inhibitory stimulation over the supplementary motor area (SMA) once daily over 3 weeks ameliorates psychomotor slowing. In this trial the investigators use a shorter inhibitory protocol called cTBS and to be applied 3 times per day. This should lead to faster treatment response and less burden to patients. The main question the investigators aim to answer are: Can the treatment with cTBS 3 times per day ameliorate psychomotor slowing in schizophrenia over one week? Participants will complete questionnaires on the first and last day of the study. Each day, participants will receive the TMS-treatment. Optionally, participants can receive a cerebral MRI before the study and/or come for an additional day 6 to repeat some of the questionnaires. There is no comparison group. All participants will receive the same treatment.

Who can participate

Age range

18 Years – 60 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: * 18-60 years. * Ability and willingness to participate in the study * Ability to provide written informed consent * Informed Consent as documented by signature (Appendix Informed Consent Form) * Schizophrenia spectrum disorders according to DSM-5 with psychomotor slowing (SRRS score ≥ 15). Exclusion Criteria: * Substance abuse or dependence other than nicotine. * Past or current medical or neurological conditions associated with impaired or aberrant movement, such as brain tumors, stroke, M. Parkinson, M. Huntington, dystonia. * Severe head trauma with subsequent loss of consciousness. * Epilepsy or other convulsions. * History of any hearing problems or ringing in the ears. * Standard exclusion criteria for TMS (implanted electronic devices (e.g. pacemakers, implantable cardioverter-defibrillators, vagus nerve stimulators and wearable cardioverter-defibrillators, ocular implants, deep brain stimulators, implanted medication pumps, intracardiac lines even when removed) and/or conductive objects near the coil (e.g. cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments) * Women who are pregnant or breastfeeding. * Any TMS treatment in the past 2 months. * If applicable: standard exclusion criteria for MRI (study participation without MRI is possible) * Intention to become pregnant during the course of the study * Previous enrolment into the current study * Enrolment of the investigator, his/her family m…

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

Change in Salpetriere Retardation Rating Scale (SSRS) from baseline

Timeframe: At baseline, day 3, post at day 5, and follow-up 1 week later

Proportion of responders in SRRS

Timeframe: At baseline, day 3, post at day 5, and follow-up 1 week later

Trial details

NCT IDNCT06134661

SponsorUniversity of Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-30

View on ClinicalTrials.gov More Schizophrenia; Psychosis trials