16 Participants NeededMy employer runs this trial

Accelerated iTBS for PTSD and Depression

RK
MB
Overseen ByMervin Blair, PhD, C.Psych
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Lawson Research Institute of St. Joseph's
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, faster method of magnetic brain stimulation called Accelerated intermittent theta burst stimulation (iTBS) to aid adults with PTSD and depression. The goal is to determine if six short sessions each day for five days are practical, safe, and effective. Researchers aim to assess whether this approach can improve symptoms like anxiety and depression and enhance quality of life. Suitable candidates include individuals with PTSD and depression who are on stable treatment plans and can attend sessions in London. Participants will also undergo brain activity assessments and return for follow-up visits. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment options.

What prior data suggests that accelerated iTBS is safe for adults with PTSD and MDD?

Research has shown that accelerated intermittent theta burst stimulation (iTBS) is generally safe and well-tolerated. In several studies, people receiving iTBS for PTSD or depression experienced significant improvements without serious side effects. One study found that iTBS reduced PTSD symptoms in veterans without causing major problems. Another study showed that iTBS led to noticeable improvements, again with no severe side effects.

While some mild side effects like headaches or scalp discomfort can occur, they usually don't last long. Overall, the treatment has shown promise in effectively and safely reducing symptoms.12345

Why are researchers excited about this trial?

Researchers are excited about accelerated intermittent theta burst stimulation (iTBS) for PTSD and depression because it offers a faster treatment option compared to traditional therapies like antidepressants and psychotherapy, which can take weeks or months to show effects. This new approach uses short bursts of magnetic pulses to stimulate specific areas of the brain, potentially providing relief in just five days with multiple sessions per day. Unlike conventional treatments, iTBS directly targets brain activity patterns linked to these conditions, which may lead to quicker and more effective outcomes.

What evidence suggests that accelerated iTBS is effective for PTSD and depression?

Research has shown that accelerated intermittent theta burst stimulation (iTBS), which participants in this trial will receive, can help reduce symptoms of PTSD and depression. One study showed that iTBS reduced PTSD symptoms by 18-22 points, with 65% of participants responding positively. Another study found that iTBS can improve symptoms quickly, often early in the treatment. This method matches the effectiveness of other types of magnetic brain stimulation but works faster. Overall, iTBS shows promise in improving symptoms of both PTSD and depression.23678

Who Is on the Research Team?

RK

Radhika Kelkar, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with both post-traumatic stress disorder (PTSD) and major depressive disorder (MDD). Participants should be able to attend daily sessions over five days and complete follow-up visits.

Inclusion Criteria

Sufficient English proficiency to complete consent and study assessments
Minimum symptom severity at baseline: HAMD-17 score ≥14 and/or PCL-5 score ≥33
I have both PTSD and major depression diagnosed by a structured interview.
See 3 more

Exclusion Criteria

Inability to comply with study schedule
Psychiatric or substance-related risks including current psychotic disorder, acute mania, Bipolar I or II disorder diagnosis, recent substance use disorder, or imminent suicide risk
Enrollment in another interventional trial
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive six short sessions of magnetic brain stimulation per day for five days

1 week
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
3 visits (in-person) at Week 2, Week 5, and Week 12

What Are the Treatments Tested in This Trial?

Interventions

  • Accelerated intermittent theta burst stimulation

Trial Overview

The study tests an accelerated schedule of intermittent theta burst stimulation (iTBS), a non-invasive magnetic brain stimulation, given six times per day for five days. The goal is to see if this faster treatment is practical, safe, and helpful for PTSD and depression symptoms.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Accelerated iTBSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lawson Research Institute of St. Joseph's

Lead Sponsor

Citations

Theta Burst Transcranial Magnetic Stimulation for ... - PMC - NIH

iTBS appears to be a promising new treatment for PTSD. Most clinical improvements from stimulation occurred early, necessitating further ...

Effects of intermittent theta-burst transcranial magnetic ...

ITBS, with a shorter treatment duration, can effectively improve the symptoms of PTSD, with no significant difference in effect from that of rTMS. Future ...

A multisite, propensity-matched cohort study of treatment ...

All three TMS protocols produced substantial PTSD symptom reductions (18–22 points). PTSD response rates were 63 % (10 Hz), 65 % (iTBS), and 78 % (dTMS); ...

Effectiveness of transcranial magnetic stimulation for ...

All three TMS protocols produced substantial PTSD symptom reductions (18-22 points). PTSD response rates were 63 % (10 Hz), 65 % (iTBS), and ...

One-year clinical outcomes following theta burst ...

We previously reported active intermittent TBS (iTBS) was associated with superior clinical outcomes for up to 1-month, in a sample of fifty ...

Intermittent theta burst stimulation in Canadian soldiers ...

We monitored safety and tolerability of the iTBS regimen. Data were collected in 2015–2016. Results PTSD remission rate reached 21 %

Theta-Burst Transcranial Magnetic Stimulation for ...

iTBS appears to be a promising new treatment for PTSD. Most clinical improvements from stimulation occurred early, which suggests a need for ...

Accelerated TMS to a Novel Brain Target in MDD and PTSD

This is a Clinical Trial designed to evaluate novel transcranial magnetic stimulation (TMS) methods for treating depression/PTSD.