SMA Targeted Magnetic Stimulation Against Auditory Verbal Hallucinations (NCT04651621) | Clinical Trial Compass
TerminatedNot Applicable
SMA Targeted Magnetic Stimulation Against Auditory Verbal Hallucinations
Stopped: Slow recruitment
Sweden46 participantsStarted 2020-11-02
Plain-language summary
Auditory verbal hallucinations (AVH) are prevalent among patients with psychiatric disorders. Not only being highly stressful and functionally impairing, AVH often persist despite treatment. Recent attempts to treat AVH with add-on repetitive transcranial magnetic stimulation (rTMS) when targeting the temporoparietal junction (TPJ), a language node in the brain, has gained limited success. The aim of this investigation is to reduce AVH with rTMS using continous theta-burst stimulation over a novel target, the supplementary motor area (SMA), in participants with frequent AVH, while also assessing potential neurophysiological mechanisms underlying the symptom.
Who can participate
Age range
18 Years – 59 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:
Inclusion criteria for the AVH group:
* Reported AVH with a minimum frequency of at least daily occurrence, with onset more than one month ago
* Stable psychopharmacological treatment past month
Inclusion criteria for the non-AVH control group
* Reporting no occurrences of AVH for the past year
* Stable psychopharmacological treatment past month
Inclusion criteria for the healthy control group
* No life-time occurrence of AVH
* No history of psychiatric disorders as assessed with a Mini-International Neuropsychiatric Interview (M.I.N.I.)
Exclusion Criteria:
* Ferromagnetic or electromagnetic implants that may pose a risk during magnetic resonance imaging (MRI) and/or cTBS
* A history of epilepsy
* Pregnancy
* Current substance use disorder or a history of alcohol use disorder as assessed with Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT), urine samples with test for illicit drugs and Phosphatidylethanol (PEth)
* Daily benzodiazepine use
* Factors that make the participant unlikely to be able to complete the study
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
Amplitude on EEG in speech-listen task
Timeframe: 5-30 minutes after intervention
2
Change on The Psychotic Symptom Rating Scales (PSYRATS)
Timeframe: 1 day after completion of open treatment phase