Auditory Verbal HallucinationsNCT07902518
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
A study testing Theta-Burst Transcranial Magnetic Stimulation (TBS) in people with Auditory Verbal Hallucinations and Schizophrenia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auditory Verbal Hallucinations, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Theta-Burst Transcranial Magnetic Stimulation (TBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 10 Sep 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Institut universitaire en santé mentale de Montréal
Montreal, Quebec, H1N 3M5
Stéphane Potvin, PhD, 514-251-4015 ext. 2851, stephane.potvin@umontreal.ca
About this study
Official title: The Use of Theta-Burst Transcranial Magnetic Stimulation in the Treatment of Persistent Auditory Hallucinations: A Pilot Study
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:
Read more
- 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.
Read the detailed description
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:
- Continuous theta-burst stimulation of the left temporoparietal junction: 900 pulses at 90% of the resting motor threshold.
- Continuous theta-burst stimulation of the right temporoparietal junction: 900 pulses at 90% of the resting motor threshold.
- Intermittent theta-burst stimulation of the left dorsolateral prefrontal cortex: 600 pulses at 120% of the resting motor threshold.
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.
- Conditions
- Auditory Verbal Hallucinations, Schizophrenia, Schizoaffective Disorder, Psychotic Disorders
- Being tested
- Theta-Burst Transcranial Magnetic Stimulation (TBS)
- 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
- Medical subject headings
- Hallucinations, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta-Burst Transcranial Magnetic Stimulation (TBS)Device
Also called Repetitive Transcranial Magnetic Stimulation (rTMS), Continuous Theta-Burst Stimulation (cTBS), Intermittent Theta-Burst Stimulation (iTBS)
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Theta-Burst Stimulation (TBS) | Experimental | 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. Receives: Device: Theta-Burst Transcranial Magnetic Stimulation (TBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, approximately 1 week after treatment, and 1-month follow-up
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, approximately 1 week after treatment, and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start10 Sep 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory Verbal HallucinationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label pilot study evaluating the effects and tolerability of theta-burst stimulation (TBS) in adults with treatment-resistant auditory verbal hallucinations. All participants receive the same active intervention, consisting of bilateral continuous theta-burst stimulation (cTBS) targeting the temporoparietal junctions and intermittent theta-burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex. No randomization or control group is included.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stéphane Potvin, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Stéphane Potvin, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902518
- Sponsor's protocol ID
- TMS-HALLUCINATIONS-2025
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Theta-Burst Transcranial Magnetic Stimulation in the Treatment of Persistent Auditory Hallucinations: A Pilot Study
- ClinicalTrials.gov ID
- NCT07902518
- Acronym / sponsor ID
- TMS-HALLUCINATIONS-2025
- Conditions
- Auditory Verbal Hallucinations, Schizophrenia, Schizoaffective Disorder, Psychotic Disorders
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Continuous theta-burst stimulation of the left temporoparietal junction: 900 pulses at 90% of the resting motor threshold.
- Continuous theta-burst stimulation of the right temporoparietal junction: 900 pulses at 90% of the resting motor threshold.
- Intermittent theta-burst stimulation of the left dorsolateral prefrontal cortex: 600 pulses at 120% of the resting motor threshold.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label pilot study evaluating the effects and tolerability of theta-burst stimulation (TBS) in adults with treatment-resistant auditory verbal hallucinations. All participants receive the same active intervention, consisting of bilateral continuous theta-burst stimulation (cTBS) targeting the temporoparietal junctions and intermittent theta-burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex. No randomization or control group is included.
| Arm | Type | Receives |
|---|---|---|
| Active Theta-Burst Stimulation (TBS) | Experimental | Device: Theta-Burst Transcranial Magnetic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theta-Burst Transcranial Magnetic Stimulation (TBS)Also: Repetitive Transcranial Magnetic Stimulation (rTMS), Continuous Theta-Burst Stimulation (cTBS), Intermittent Theta-Burst Stimulation (iTBS)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. | Device | Active Theta-Burst Stimulation (TBS) |
Primary outcome
Change in Auditory Hallucination Severity (PSYRATS-AH)
Time frame: Baseline, approximately 1 week after treatment, and 1-month follow-up
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.
5 secondary outcomes
Change in Overall Psychotic Symptom Severity (PANSS)
Time frame: Baseline, approximately 1 week after treatment, and 1-month follow-up
Change in Depressive Symptoms (MADRS)
Time frame: Baseline, approximately 1 week after treatment, and 1-month follow-up
Change in Subjective Cognitive Difficulties (SSTICS)
Time frame: Baseline, approximately 1 week after treatment, and 1-month follow-up
Change in Insight into Illness (PANSS G12)
Time frame: Baseline, approximately 1 week after treatment, and 1-month follow-up
Change in Functional Impairment (Sheehan Disability Scale)
Time frame: Baseline, approximately 1 week after treatment, and 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphane Potvin, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theta-Burst Transcranial Magnetic Stimulation (TBS) in people with Auditory Verbal Hallucinations and Schizophrenia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naomi White, Msc (514-887-3401, naomi.white@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Auditory Hallucination Severity (PSYRATS-AH) (time frame: Baseline, approximately 1 week after treatment, and 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.