Recruiting

iTBS

Sponsor:

Douglas Mental Health University Institute

Code:

NCT07786714

Conditions

Clinical High Risk for Psychosis (CHR)

Psychotic Disorders

Prodromal Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 34

Healthy Volunteers: Not accepted

Interventions

Active Intermittent Theta Burst Stimulation (BEAM-F3 Targeting)

Sham Comparator: Sham iTBS

Study Details

Brief 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.

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.

Conditions

Clinical High Risk for Psychosis (CHR)

Psychotic Disorders

Prodromal Symptoms

Study ID

NCT07786714

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 34

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active iTBS (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 comparator: Sham iTBS

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.

Interventions

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.

Sham Comparator: Sham iTBS

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.

Primary outcome measure

  • Treatment Initiation Rate [ Time Frame: Through end of treatment week (Day 5) ]
  • Treatment Acceptability Rate [ Time Frame: Through study completion, an average of 18 months. ]
  • Treatment Adherence [ Time Frame: Through end of treatment week (Day 5) ]
  • Treatment Completion Rate [ Time Frame: Through end of treatment week (Day 5) ]
  • Incidence of Adverse and Serious Adverse Events [ Time Frame: Baseline through 3-month follow-up ]
  • Qualitative Treatment Experience [ Time Frame: End of treatment (Day 5) ]

Central Contacts and Locations

Central contacts

Ashley Choucroun

5146593488ashley.choucroun.comtl@ssss.gouv.qc.ca

Locations

McGill Lab for Computational Psychiatry and Translation

Recruiting

Verdun, Quebec, Canada, H4H1R3

Contacts

Ashley Choucroun

5146593488ashley.choucroun.comtl@ssss.gouv.qc.ca

Principal Investigator:

David Benrimoh

More Information

Sponsor

Douglas Mental Health University Institute

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • Neuromodulation Therapy
  • Non-invasive Brain Stimulation
  • Accelerated Treatment
  • Transcranial Magnetic Stimulation
  • Outpatient treatment
  • iTBS
  • TMS
  • psychosis
  • CHR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Douglas Mental Health University Institute on 2026-08-28.