Recruiting

Accelerated iTBS

Sponsor:

Lawson Research Institute of St. Joseph's

Code:

NCT07682207

Conditions

Post Traumatic Stress Disorder PTSD

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Accelerated intermittent theta burst stimulation

Study Details

Brief summary:

The goal of this pilot clinical trial is to learn if a faster brain stimulation schedule is practical, safe, tolerable, and acceptable. This study looks at accelerated intermittent theta burst stimulation, or accelerated iTBS. This is a non-invasive type of magnetic brain stimulation. This study is for adults with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD).

The main questions this study aims to answer are:

1. Can participants complete six short brain stimulation sessions per day for five days?
2. Is this treatment schedule safe and tolerable for participants?
3. What changes occur in depression symptoms, PTSD symptoms, anxiety, quality of life, and brain activity over time?

Participants will:

1. Complete health screening and baseline assessments.
2. Receive six short sessions of magnetic brain stimulation per day for five days.
3. Have their brain activity measured using an EEG recording.
4. Return for a post-treatment assessment at Week 2 and follow-up visits at Week 5 and Week 12.

Conditions

Post Traumatic Stress Disorder PTSD

Major Depressive Disorder (MDD)

Study ID

NCT07682207

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Current post-traumatic stress disorder (PTSD) and current major depressive disorder (MDD), confirmed by a structured diagnostic interview (e.g., MINI 6.0 using the PTSD and MDD modules).
  • Minimum symptom severity at baseline: HAMD-17 score ≥14 (moderate depression) and/or PCL-5 score ≥33 (probable PTSD).
  • On a stable pharmacologic and/or psychotherapeutic regimen for at least 4 weeks prior to baseline, and willing to maintain stability during the treatment phase, unless medically necessary.
  • Capacity to provide informed consent and comply with study procedures and visits at St. Joseph's Health Care, London/Parkwood Institute.
  • Sufficient English proficiency to complete consent and study assessments.

Exclusion Criteria:

  • Neurologic or device-related risks, including seizure history, traumatic brain injury with loss of consciousness greater than 5 minutes, major neurologic illness, or metal/electronic implants contraindicated for transcranial magnetic stimulation.
  • Psychiatric or substance-related risks, including current psychotic disorder, acute mania, diagnosis of Bipolar I or Bipolar II disorder, recent substance use disorder, or imminent suicide risk.
  • Medical or medication-related risks, including unstable severe illness, high-risk medications, hearing impairment, unwillingness to use ear protection, or prior non-response to an adequate course of theta burst stimulation for the current depression/PTSD episode.
  • Enrollment in another interventional trial.
  • Inability to comply with the study schedule.

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Accelerated iTBS

Participants will receive active accelerated intermittent theta burst stimulation (iTBS). Treatment will consist of six short stimulation sessions per day delivered over five consecutive days, for a total of 30 sessions.

Interventions

Accelerated intermittent theta burst stimulation

Accelerated intermittent theta burst stimulation, also called accelerated iTBS, is a non-invasive magnetic brain stimulation intervention. Stimulation is delivered to the left dorsolateral prefrontal cortex using a transcranial magnetic stimulation system. Participants receive six short sessions per day over five consecutive days.

Primary outcome measure

  • Recruitment rate [ Time Frame: Study recruitment period, up to 12 months ]
  • Consent rate [ Time Frame: Study recruitment period, up to 12 months ]
  • Treatment adherence [ Time Frame: Treatment Days 1 through 5 ]
  • Retention through Week 12 follow-up [ Time Frame: Baseline through Week 12 ]
  • Adverse events [ Time Frame: Treatment Days 1 through Week 12 ]
  • Serious adverse events [ Time Frame: Treatment Days 1 through Week 12 ]
  • Discontinuations due to adverse events [ Time Frame: Treatment Days 1 through Week 12 ]
  • Participant satisfaction with accelerated iTBS [ Time Frame: Week 2, Week 5, and Week 12 ]
  • Participant feedback on accelerated iTBS [ Time Frame: Week 2, Week 5, and Week 12 ]

Central Contacts and Locations

Central contacts

Radhika Kelkar, MD

519-685-8500radhika.kelkar@lhsc.on.ca

Mervin Blair, PhD, C.Psych

519-646-6100mervin.blair@sjhc.london.on.ca

Locations

St. Joseph's Health Care London, Parkwood Institute Mental Health Care Building

Recruiting

London, Ontario, Canada, N6C 0A7

Contacts

Radhika Kelkar, MD

519-685-8500radhika.kelkar@lhsc.on.ca

Mervin Blair, PhD, C.Psych

519-646-6100mervin.blair@sjhc.london.on.ca

Principal Investigator:

Radhika Kelkar, MD

More Information

Sponsor

Lawson Research Institute of St. Joseph's

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Keywords

  • PTSD
  • MDD
  • Depression
  • Feasibility study
  • Accelerated intermittent theta burst stimulation
  • iTBS
  • Theta burst stimulation
  • Transcranial magnetic stimulation
  • TMS
  • Brain stimulation
  • EEG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Lawson Research Institute of St. Joseph's on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.