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NCT07902518
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Conditions: Auditory Verbal Hallucinations, Schizophrenia, Schizoaffective Disorder, Psychotic Disorders
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 12
Sponsor: Ciusss de L'Est de l'Île de Montréal
Location: Institut universitaire en santé mentale de Montréal Montreal Quebec
Summary
The goal of this clinical trial is to learn whether theta-burst transcranial magnetic stimulation (TBS), a non-invasive brain stimulation technique, can help reduce persistent auditory verbal hallucinations (hearing voices) in adults with psychotic disorders who have not responded adequately to antipsychotic medications.
The main questions it aims to answer are:
* Does theta-burst stimulation reduce the severity of auditory verbal hallucinations?
* Does theta-burst stimulation improve other psychiatric symptoms, including depressive symptoms and insight into illness?
* How well do participants tolerate this treatment, and what side effects do they experience?
All participants will receive active theta-burst stimulation. There is no placebo or comparison group.
Participants will:
* Complete an initial assessment of their mental health, symptoms, and medical history.
* Receive 20 brain stimulation sessions over two consecutive weeks, with two sessions per day on weekdays.
* Complete follow-up assessments approximately one week and one month after treatment to evaluate changes in symptoms and overall functioning.
* Report any side effects experienced during treatment and follow-up.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older.
* Diagnosis of a schizophrenia-spectrum disorder or bipolar disorder with psychotic symptoms.
* Presence of persistent auditory verbal hallucinations with persecutory content.
* Auditory verbal hallucinations s that have not responded to ≥2 antipsychotic trials, each lasting more than 6 weeks, with daily chlorpromazine-equivalent doses of ≥600 mg and ≥80% of doses taken.
* Stable pharmacological treatment for at least two months before enrollment.
Exclusion Criteria:
* History of epilepsy or seizures.
* Neurological disorders that may interfere with the study or increase the risks associated with transcranial magnetic stimulation.
* Substance use disorder within the previous six months.
* Electroconvulsive therapy (ECT) within the previous six months.
* Any other contraindication to transcranial magnetic stimulation.
Source: ClinicalTrials.gov (NCT07902518). StuddyBuddy aggregates publicly available trial information.