Recruiting

TBS

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT07902518

Conditions

Auditory Verbal Hallucinations

Schizophrenia

Schizoaffective Disorder

Psychotic Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Theta-Burst Transcranial Magnetic Stimulation (TBS)

Study Details

Brief 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.

Conditions

Auditory Verbal Hallucinations

Schizophrenia

Schizoaffective Disorder

Psychotic Disorders

Study ID

NCT07902518

Start date

Sep 10, 2025

Status verified date

Oct, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Theta-Burst Stimulation (TBS)

Participants will receive active theta-burst stimulation (TBS) targeting three brain regions: at the temporoparietal junctions and the left dorsolateral prefrontal cortex.

Each treatment session will combine bilateral continuous theta-burst stimulation (cTBS; 900 pulses per hemisphere at 90% of the resting motor threshold) and intermittent theta-burst stimulation (iTBS; 600 pulses at 120% of the resting motor threshold) targeting the left dorsolateral prefrontal cortex.

Participants will receive two treatment sessions per day over 10 weekdays, for a total of 20 sessions.

Interventions

Theta-Burst Transcranial Magnetic Stimulation (TBS)

Theta-burst stimulation (TBS) will be delivered using a MagPro transcranial magnetic stimulation system (MagVenture) equipped with a B-70 coil.

Each session will combine bilateral continuous theta-burst stimulation (cTBS) targeting the temporoparietal junctions (900 pulses per hemisphere at 90% of the resting motor threshold) and intermittent theta-burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (600 pulses at 120% of the resting motor threshold).

Stimulation targets will be identified using the international 10-20 EEG system (F3 for the left dorsolateral prefrontal cortex and the midpoint between T3 and P3 for the left temporoparietal junction).

Participants will receive two sessions daily over 10 weekdays, for a total of 20 treatment sessions.

Primary outcome measure

  • Change in Auditory Hallucination Severity (PSYRATS-AH) [ Time Frame: Baseline, approximately 1 week after treatment, and 1-month follow-up ]

Central Contacts and Locations

Central contacts

Naomi White, Msc

514-887-3401naomi.white@umontreal.ca

Locations

Institut universitaire en santé mentale de Montréal

Recruiting

Montreal, Quebec, Canada, H1N 3M5

Contacts

Stéphane Potvin, PhD

514-251-4015stephane.potvin@umontreal.ca

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • Treatment-Resistant Auditory Hallucinations
  • Auditory Verbal Hallucinations
  • Theta-Burst Stimulation
  • Transcranial Magnetic Stimulation
  • Repetitive Transcranial Magnetic Stimulation
  • Continuous Theta-Burst Stimulation
  • Intermittent Theta-Burst Stimulation
  • Schizophrenia
  • Psychosis
  • Neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.