An interventional study of Theta-Burst Transcranial Magnetic Stimulation (TBS) in Auditory Verbal Hallucinations, Schizophrenia and Schizoaffective Disorder, sponsored by Ciusss de L'Est de l'Île de Montréal. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Ciusss de L'Est de l'Île de Montréal · Not applicable, Interventional, and Treatment
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:
All participants will receive active theta-burst stimulation. There is no placebo or comparison group.
Participants will:
Background and Rationale
Auditory verbal hallucinations are among the most disabling symptoms experienced by individuals with schizophrenia and other psychotic disorders. Approximately one-third of individuals with psychotic disorders do not achieve an adequate response to antipsychotic treatment and may continue to experience persistent hallucinations associated with substantial psychological distress and functional impairment.
Although clozapine and psychological interventions represent important therapeutic options, their effectiveness may be limited in individuals with treatment-resistant symptoms. Consequently, there is a need to investigate additional therapeutic approaches.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that uses magnetic pulses to modulate cortical activity. Previous studies investigating rTMS for auditory hallucinations have produced mixed results, particularly when using low-frequency stimulation of the left temporoparietal junction.
Theta-burst stimulation (TBS), a more recent form of rTMS, delivers high-frequency stimulation in brief bursts. Depending on the stimulation pattern, TBS can produce inhibitory or excitatory effects on cortical activity.
Preliminary clinical studies suggest that bilateral temporoparietal stimulation may be a promising approach for persistent auditory hallucinations. However, additional research is required to establish its potential therapeutic benefits.
Study Objectives
The primary objective of this pilot study is to explore the potential therapeutic effects of a novel TBS protocol on the severity of persistent, treatment-resistant auditory verbal hallucinations.
Secondary objectives include exploring changes in depressive symptoms, insight into illness, other psychiatric symptoms, subjective cognitive difficulties, and functioning, as well as evaluating treatment tolerability.
Study Design
This study is a single-arm, open-label, prospective pilot trial using a pre-post design.
A total of 12 adult participants with psychotic disorders and persistent auditory verbal hallucinations resistant to antipsychotic treatment will be recruited at the Institut universitaire en santé mentale de Montréal (IUSMM), Quebec, Canada.
All participants will receive the same active stimulation protocol. No randomization, sham stimulation, or placebo comparison group will be used.
Intervention
The intervention combines continuous theta-burst stimulation (cTBS) of the bilateral temporoparietal junctions with intermittent theta-burst stimulation (iTBS) of the left dorsolateral prefrontal cortex.
The protocol will be administered using MagPro transcranial magnetic stimulation equipment (MagVenture) equipped with a B-70 stimulation coil.
Each treatment session will include:
The temporoparietal junctions will be targeted bilaterally, while the left dorsolateral prefrontal cortex will be localized using the F3 position of the international 10-20 EEG system.
Participants will receive two treatment sessions per day over 10 weekdays, for a total of 20 stimulation sessions across two consecutive weeks.
Clinical Assessments
Clinical assessments will be conducted before treatment, following the intervention, and at a one-month follow-up.
The primary clinical measure will be the auditory hallucinations subscale of the Psychotic Symptom Rating Scales (PSYRATS), which evaluates the severity and characteristics of auditory hallucinations.
Additional assessments will include the Positive and Negative Syndrome Scale (PANSS), Montgomery-Åsberg Depression Rating Scale (MADRS), Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS) and the Sheehan Disability Scale (SDS).
Insight into illness will be assessed using item G12 of the PANSS.
Treatment tolerability will be evaluated by documenting treatment attendance, delays between sessions, and adverse effects occurring during or between stimulation sessions. Adverse effects will also be assessed during follow-up visits.
Statistical Analysis
Given the exploratory nature of this pilot study, analyses will primarily focus on estimating the magnitude of changes in clinical outcomes.
Linear mixed-effects models will be used to examine changes in auditory hallucination severity across assessment time points.
Effect sizes will be calculated using Cohen's d to provide preliminary estimates of the potential therapeutic effects of the intervention.
These findings may inform sample-size calculations and the design of a future randomized, sham-controlled clinical trial.
136 studies on the registry are indexed under Hallucinations; 35 are open to participants now.
This study's planned enrollment of 12 is below the median of 48 across 118 interventional studies indexed under Hallucinations.
Browse Hallucinations studies →Ciusss de L'Est de l'Île de Montréal is the lead sponsor of 90 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
Also known as: Repetitive Transcranial Magnetic Stimulation (rTMS), Continuous Theta-Burst Stimulation (cTBS), Intermittent Theta-Burst Stimulation (iTBS)
Change in Auditory Hallucination Severity (PSYRATS-AH)
Severity of auditory verbal hallucinations will be assessed using the auditory hallucinations subscale of the Psychotic Symptom Rating Scales (PSYRATS-AH). This 11-item clinician-rated scale measures different characteristics of auditory hallucinations, including frequency, duration, distress, and disruption to daily life. Total scores range from 0 to 44, with higher scores indicating greater hallucination severity.
Time frame: Baseline, approximately 1 week after treatment, and 1-month follow-up
Change in Overall Psychotic Symptom Severity (PANSS)
Psychotic symptom severity will be assessed using the Positive and Negative Syndrome Scale (PANSS). The scale includes 30 clinician-rated items evaluating positive symptoms, negative symptoms, and general psychopathology. Total scores range from 30 to 210, with higher scores indicating greater symptom severity.
Time frame: Baseline, approximately 1 week after treatment, and 1-month follow-up
Change in Depressive Symptoms (MADRS)
Depressive symptoms will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), a 10-item clinician-rated measure of depression severity. Total scores range from 0 to 60, with higher scores indicating more severe depressive symptoms.
Time frame: Baseline, approximately 1 week after treatment, and 1-month follow-up
Change in Subjective Cognitive Difficulties (SSTICS)
Subjective cognitive difficulties will be assessed using the Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS), a self-report questionnaire measuring perceived cognitive difficulties in everyday life. Higher scores indicate greater subjective cognitive difficulties.
Time frame: Baseline, approximately 1 week after treatment, and 1-month follow-up
Change in Insight into Illness (PANSS G12)
Insight into illness will be assessed using item G12 (Lack of Judgment and Insight) of the Positive and Negative Syndrome Scale (PANSS). Scores range from 1 to 7, with higher scores indicating greater impairment in insight.
Time frame: Baseline, approximately 1 week after treatment, and 1-month follow-up
Change in Functional Impairment (Sheehan Disability Scale)
Functional impairment will be assessed using the Sheehan Disability Scale (SDS), a self-report measure evaluating impairment in work or school, social life, and family life. Each domain is scored from 0 to 10, with higher scores indicating greater impairment. The total score ranges from 0 to 30.
Time frame: Baseline, approximately 1 week after treatment, and 1-month follow-up
Tolerability of Theta-Burst Stimulation
Treatment tolerability will be evaluated by documenting adverse effects reported during treatment sessions and follow-up assessments, including their nature and frequency.
Time frame: Throughout the 2-week treatment period and up to the 1-month follow-up
Treatment Completion Rate
Treatment completion will be assessed by recording the number of theta-burst stimulation sessions completed by each participant out of the 20 planned sessions.
Time frame: Throughout the 2-week treatment period
Plan to share: No
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Started Sep 2025 (actual). Primary completion is estimated for Dec 2027, 27 months after the start.
Of 53 non-industry interventional studies with no phase under Hallucinations, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 56. This study's planned 27 months is below that.
Counting every sponsor, half of 53 studies reached it within 37 months; a quarter within 20 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Ciusss de L'Est de l'Île de Montréal