Clinical High Risk for Psychosis (CHR)TMS-CHRNCT07786714
Accelerated Neuromodulation Therapy and Neurocomputational Biomarkers in Individuals at Clinical High Risk for Psychosis
A study testing Active Intermittent Theta Burst Stimulation (BEAM-F3 Targeting) in people with Clinical High Risk for Psychosis (CHR) and Psychotic Disorders, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial summary
The goal of this study is to learn whether an accelerated form of neuromodulation therapy is safe, feasible, and well tolerated in young people at clinical high risk for psychosis (CHR-P), and whether it is associated with changes in candidate biomarkers of treatment response. Read more about this study
- Who is it for?
- Ages 18 to 34 years
- Conditions the study is for
- Clinical High Risk for Psychosis (CHR), Psychotic Disorders, Prodromal Symptoms
- What is being tested?
- Active Intermittent Theta Burst Stimulation (BEAM-F3 Targeting)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2026to Dec 2029
- 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 to 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets clinical CHR-P criteria, confirmed by the Structured Interview for Psychosis-Risk Syndromes (SIPS)
- Clinical team confirms sufficient stability to participate
- Able to provide informed consent
Who cannot join
- Pregnancy, lactation, or intrauterine device
- History of electroconvulsive therapy (ECT) in the past 6 months
- Substance use during the treatment week (cigarettes and cannabis excluded from this consideration)
- Contraindications for TMS (e.g., metal implants in head/neck, seizure history, brain tumor/neurosurgery, severe cardiac disease)
- Previous rTMS treatment
- Documented history of significant intellectual disability
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
McGill Lab for Computational Psychiatry and Translation
Verdun, Quebec, H4H1R3
Ashley Choucroun, 5146593488, ashley.choucroun.comtl@ssss.gouv.qc.ca
David Benrimoh
About this study
The goal of this study is to learn whether an accelerated form of neuromodulation therapy is safe, feasible, and well tolerated in young people at clinical high risk for psychosis (CHR-P), and whether it is associated with changes in candidate biomarkers of treatment response.
Participants will be randomly assigned to receive either active accelerated intermittent theta burst stimulation (iTBS) or sham stimulation to the left dorsolateral prefrontal cortex, delivered over five consecutive days.
Read more
The study will look at whether this accelerated treatment approach is safe and feasible for people at clinical high risk for psychosis, whether depressive symptoms improve after treatment, and whether computerized behavioural tasks and passive digital monitoring (wearables, smartphone apps, and speech analysis) can detect treatment-related changes that may serve as biomarkers for future, larger trials.
Participants will complete clinical interviews and questionnaires, a cognitive battery, and computerized behavioral tasks; wear a Fitbit and use smartphone applications for at least two weeks before and throughout treatment; receive neuromodulation therapy or sham stimulation over five consecutive days; and attend follow-up visits at 1 week, 1 month, and 3 months after treatment.
Read the detailed description
There is currently no clinically validated treatment that reduces the risk of psychosis onset or mitigates the severity of a first psychotic episode in individuals at clinical high risk for psychosis (CHR-P). CHR-P is associated with attenuated psychotic symptoms, functional decline, and high rates of affective symptoms, including a comorbid mood disorder prevalence of 40% or higher. Repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (LDLPFC) is an established treatment for depression and is increasingly supported for negative symptoms in psychotic disorders, making it a promising low-burden candidate for early intervention in CHR-P.
This pilot study evaluates an accelerated intermittent theta burst stimulation (iTBS) protocol, delivered over five consecutive days, in individuals at CHR-P (SIPS-confirmed, aged 18-34). Forty participants will be randomized 1:1 to active accelerated iTBS or sham stimulation to the LDLPFC, using standard scalp-based (BEAM-F3) targeting rather than MRI-guided neuronavigation, reflecting the pilot nature and funding constraints of this early-phase study.
Given the variable incidence of and long latency to psychosis onset in the CHR-P population, this study also incorporates a battery of neurocomputational tasks (analyzed using Hierarchical Gaussian Filter modeling) and a multimodal digital phenotyping framework (wearables, smartphone-based passive sensing, facial/vocal affect analysis, and structured speech analysis) to assess candidate biomarkers of treatment response.
Primary outcomes are the safety, feasibility, and tolerability of the accelerated protocol in this population. Secondary outcomes include the sensitivity of neurocomputational biomarkers to treatment and change in depressive symptoms. Exploratory outcomes include treatment-related change across multiple domains of real-world functioning captured through digital phenotyping. This study is not designed to establish definitive treatment efficacy but to inform the design of future, adequately powered trials.
- Being tested
- Active Intermittent Theta Burst Stimulation (BEAM-F3 Targeting), Sham Comparator: Sham iTBS
- Keywords
- Neuromodulation Therapy, Non-invasive Brain Stimulation, Accelerated Treatment, Transcranial Magnetic Stimulation, Outpatient treatment, iTBS, TMS, psychosis, CHR
- Medical subject headings
- Psychotic Disorders, Prodromal Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Intermittent Theta Burst Stimulation (BEAM-F3 Targeting)Device
Active iTBS is delivered using a MagVenture MagPro X100 stimulator with Cool-B65 A/P coil, targeting the LDLPFC at 110% of resting motor threshold (motor threshold determined via the PEST algorithm). Each session consists of 60 trains of 10 bursts of three pulses at 50 Hz, delivered every 200 ms, with an 8-second intertrain interval (1,800 pulses/session; up to 18,000 pulses/day; 90,000 pulses total over 5 days). The number of daily sessions is reviewed after every five participants and may be reduced from 10 to 8, or to 6, if needed; missed sessions are made up during the following week to preserve total pulse dose.
Sham Comparator: Sham iTBSDevice
Sham iTBS is delivered using the same MagVenture Cool B65 A/P coil (device-integrated sham mode), with identical coil placement, session structure, and treatment schedule as the active arm.
| Study group | Role | What they receive |
|---|---|---|
| Active iTBS (BEAM-F3 Targeting) | Experimental | Participants receive active accelerated iTBS over five consecutive days (up to 10 sessions/day, up to 50 sessions total) targeting the left dorsolateral prefrontal cortex (LDLPFC) using standard BEAM-F3 scalp-based coordinates. Receives: Device: Active Intermittent Theta Burst Stimulation (BEAM-F3 Targeting) |
| Sham iTBS | Sham comparator | Participants receive sham stimulation over five consecutive days, using the same device, coil, session structure, and schedule as the active arm, without delivering therapeutic cortical stimulation. Receives: Device: Sham Comparator: Sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Initiation Rate
Proportion of consenting participants who begin the treatment protocol (receive at least one stimulation session).
Measured: Through end of treatment week (Day 5)
Treatment Acceptability Rate
Proportion of approached, eligible individuals who consent to participate in the study.
Measured: Through study completion, an average of 18 months.
Treatment Adherence
Number of treatment sessions completed per participant, out of the planned schedule (up to 10 sessions/day over 5 days).
Measured: Through end of treatment week (Day 5)
Treatment Completion Rate
Proportion of participants who initiate treatment and complete the full course; expected completion rate of approximately 80%, based on prior work at the study site.
Measured: Through end of treatment week (Day 5)
Incidence of Adverse and Serious Adverse Events
Rate of treatment-related adverse events (e.g., scalp pain, headache, fatigue, symptom worsening) and serious adverse events (e.g., seizure, hospitalization, emergent suicidality), assessed via daily clinical ratings and structured interviews.
Measured: Baseline through 3-month follow-up
Qualitative Treatment Experience
Themes related to participant experience of tolerability and treatment burden, derived from a structured end-of-treatment qualitative interview and analyzed using inductive thematic analysis.
Measured: End of treatment (Day 5)
Secondary outcomes (6)
Change in Affective Conditioned Hallucinations Task Parameters
Change in individual-level information-processing parameters (Hierarchical Gaussian Filter modeling) derived from an affective variant of the Conditioned Hallucinations task.
Measured: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Social Appraisal Task Parameters
Change in HGF-derived parameters of social inference and belief updating.
Measured: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Beads Task Parameters
Change in probabilistic reasoning bias related to delusion-proneness.
Measured: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Prisoner's Dilemma Task Parameters
Change in HGF-derived parameters of social inference.
Measured: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score
Change in clinician-rated depressive symptom severity. Total scores range from 0 to 60, with higher scores indicating greater severity.
Measured: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Quick Inventory of Depressive Symptomatology (QIDS) Score
Change in self-reported depressive symptom severity on the Quick Inventory of Depressive Symptomatology, 16-item Self-Report (QIDS-SR16). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Measured: Baseline, Daily from Day 1 to Day 5, and at 1 week, 1 month, and 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical High Risk for Psychosis (CHR)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Benrimoh, Douglas Mental Health University Institute
- Investigators
- David Benrimoh, Principal investigator, McGill University, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786714
- Sponsor's protocol ID
- 2026-1387
- Acronym
- TMS-CHR
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Neuromodulation Therapy and Neurocomputational Biomarkers in Individuals at Clinical High Risk for Psychosis
- ClinicalTrials.gov ID
- NCT07786714
- Acronym / sponsor ID
- TMS-CHR / 2026-1387
- Keywords
- Neuromodulation Therapy, Non-invasive Brain Stimulation, Accelerated Treatment, Transcranial Magnetic Stimulation, Outpatient treatment, iTBS, TMS, psychosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 26 Aug 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 study is to learn whether an accelerated form of neuromodulation therapy is safe, feasible, and well tolerated in young people at clinical high risk for psychosis (CHR-P), and whether it is associated with changes in candidate biomarkers of treatment response.
Participants will be randomly assigned to receive either active accelerated intermittent theta burst stimulation (iTBS) or sham stimulation to the left dorsolateral prefrontal cortex, delivered over five consecutive days.
The study will look at whether this accelerated treatment approach is safe and feasible for people at clinical high risk for psychosis, whether depressive symptoms improve after treatment, and whether computerized behavioural tasks and passive digital monitoring (wearables, smartphone apps, and speech analysis) can detect treatment-related changes that may serve as biomarkers for future, larger trials.
Participants will complete clinical interviews and questionnaires, a cognitive battery, and computerized behavioral tasks; wear a Fitbit and use smartphone applications for at least two weeks before and throughout treatment; receive neuromodulation therapy or sham stimulation over five consecutive days; and attend follow-up visits at 1 week, 1 month, and 3 months after treatment.
Detailed description
There is currently no clinically validated treatment that reduces the risk of psychosis onset or mitigates the severity of a first psychotic episode in individuals at clinical high risk for psychosis (CHR-P). CHR-P is associated with attenuated psychotic symptoms, functional decline, and high rates of affective symptoms, including a comorbid mood disorder prevalence of 40% or higher. Repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (LDLPFC) is an established treatment for depression and is increasingly supported for negative symptoms in psychotic disorders, making it a promising low-burden candidate for early intervention in CHR-P.
This pilot study evaluates an accelerated intermittent theta burst stimulation (iTBS) protocol, delivered over five consecutive days, in individuals at CHR-P (SIPS-confirmed, aged 18-34). Forty participants will be randomized 1:1 to active accelerated iTBS or sham stimulation to the LDLPFC, using standard scalp-based (BEAM-F3) targeting rather than MRI-guided neuronavigation, reflecting the pilot nature and funding constraints of this early-phase study.
Given the variable incidence of and long latency to psychosis onset in the CHR-P population, this study also incorporates a battery of neurocomputational tasks (analyzed using Hierarchical Gaussian Filter modeling) and a multimodal digital phenotyping framework (wearables, smartphone-based passive sensing, facial/vocal affect analysis, and structured speech analysis) to assess candidate biomarkers of treatment response.
Primary outcomes are the safety, feasibility, and tolerability of the accelerated protocol in this population. Secondary outcomes include the sensitivity of neurocomputational biomarkers to treatment and change in depressive symptoms. Exploratory outcomes include treatment-related change across multiple domains of real-world functioning captured through digital phenotyping. This study is not designed to establish definitive treatment efficacy but to inform the design of future, adequately powered trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active iTBS (BEAM-F3 Targeting) | Experimental | Device: Active Intermittent Theta Burst Stimulation (BEAM-F3 Targeting)Participants receive active accelerated iTBS over five consecutive days (up to 10 sessions/day, up to 50 sessions total) targeting the left dorsolateral prefrontal cortex (LDLPFC) using standard BEAM-F3 scalp-based coordinates. |
| Sham iTBS | Sham comparator | Device: Sham Comparator: Sham iTBSParticipants receive sham stimulation over five consecutive days, using the same device, coil, session structure, and schedule as the active arm, without delivering therapeutic cortical stimulation. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meets clinical CHR-P criteria, confirmed by the Structured Interview for Psychosis-Risk Syndromes (SIPS)
- Clinical team confirms sufficient stability to participate
- Able to provide informed consent
Key exclusion criteria (6 listed)
- Pregnancy, lactation, or intrauterine device
- History of electroconvulsive therapy (ECT) in the past 6 months
- Substance use during the treatment week (cigarettes and cannabis excluded from this consideration)
- Contraindications for TMS (e.g., metal implants in head/neck, seizure history, brain tumor/neurosurgery, severe cardiac disease)
- Previous rTMS treatment
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 |
|---|---|---|
| Active Intermittent Theta Burst Stimulation (BEAM-F3 Targeting)Active iTBS is delivered using a MagVenture MagPro X100 stimulator with Cool-B65 A/P coil, targeting the LDLPFC at 110% of resting motor threshold (motor threshold determined via the PEST algorithm). Each session consists of 60 trains of 10 bursts of three pulses at 50 Hz, delivered every 200 ms, with an 8-second intertrain interval (1,800 pulses/session; up to 18,000 pulses/day; 90,000 pulses total over 5 days). The number of daily sessions is reviewed after every five participants and may be reduced from 10 to 8, or to 6, if needed; missed sessions are made up during the following week to preserve total pulse dose. | Device | Active iTBS (BEAM-F3 Targeting) |
| Sham Comparator: Sham iTBSSham iTBS is delivered using the same MagVenture Cool B65 A/P coil (device-integrated sham mode), with identical coil placement, session structure, and treatment schedule as the active arm. | Device | Sham iTBS |
Primary outcome
Treatment Initiation Rate
Time frame: Through end of treatment week (Day 5)
Proportion of consenting participants who begin the treatment protocol (receive at least one stimulation session).
Treatment Acceptability Rate
Time frame: Through study completion, an average of 18 months.
Proportion of approached, eligible individuals who consent to participate in the study.
Treatment Adherence
Time frame: Through end of treatment week (Day 5)
Number of treatment sessions completed per participant, out of the planned schedule (up to 10 sessions/day over 5 days).
Treatment Completion Rate
Time frame: Through end of treatment week (Day 5)
Proportion of participants who initiate treatment and complete the full course; expected completion rate of approximately 80%, based on prior work at the study site.
Incidence of Adverse and Serious Adverse Events
Time frame: Baseline through 3-month follow-up
Rate of treatment-related adverse events (e.g., scalp pain, headache, fatigue, symptom worsening) and serious adverse events (e.g., seizure, hospitalization, emergent suicidality), assessed via daily clinical ratings and structured interviews.
Qualitative Treatment Experience
Time frame: End of treatment (Day 5)
Themes related to participant experience of tolerability and treatment burden, derived from a structured end-of-treatment qualitative interview and analyzed using inductive thematic analysis.
6 secondary outcomes
Change in Affective Conditioned Hallucinations Task Parameters
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Social Appraisal Task Parameters
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Beads Task Parameters
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Prisoner's Dilemma Task Parameters
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Quick Inventory of Depressive Symptomatology (QIDS) Score
Time frame: Baseline, Daily from Day 1 to Day 5, and at 1 week, 1 month, and 3 months post-treatment
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 28 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
David Benrimoh principal investigator
McGill University, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Intermittent Theta Burst Stimulation (BEAM-F3 Targeting) in people with Clinical High Risk for Psychosis (CHR) and Psychotic Disorders, run by Douglas Mental Health University Institute 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 3 inclusion and 6 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 28 Aug 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. Some participants in this study may receive a placebo. 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 Ashley Choucroun (5146593488, ashley.choucroun.comtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Initiation Rate (time frame: Through end of treatment week (Day 5)). The study lists 6 primary outcomes in all. 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 28 Aug 2026.