Therapeutic treatment for PTSD using Deep Brain Reorienting

The Effects of Deep Brain Reorienting (DBR) on Post-traumatic Stress Disorder (PTSD)

This study is testing a new treatment called Deep Brain Reorienting to see if it can help people with PTSD manage their symptoms better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 214 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other)
• Locations: 1 site (London, Ontario)
• Trial ID: NCT04317820 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy of Deep Brain Reorienting (DBR) as a treatment for Post-traumatic Stress Disorder (PTSD). Participants will be randomly assigned to receive either the DBR treatment or be placed on a wait-list. The DBR approach involves processing traumatic memories while focusing on muscle tensions associated with threat orientation, aiming to help participants manage their emotional responses. Assessments will include clinical interviews and fMRI scans conducted both online and in-person to measure changes in PTSD symptoms.

Who should consider this trial

Good fit: Ideal candidates are English-speaking adults aged 18-65 who meet the diagnostic criteria for PTSD and may benefit from short-term trauma therapy.

Not a fit: Patients with significant untreated medical illnesses, neurological disorders, or those currently engaged in extensive counseling therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce PTSD symptoms and improve the quality of life for affected individuals.

How similar studies have performed: While the approach of DBR is innovative, similar studies exploring therapeutic techniques for PTSD have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* English speaking
* age: 18-65
* meets diagnostic criteria for PTSD (as determined by study assessment)
* may benefit from short-term trauma therapy (as determined by study assessment)

Exclusion Criteria:

* Individuals with any implants, conditions, etc. that do not comply with 7-Tesla (7T) fMRI research safety standards (e.g., certain implants, pregnancy)
* history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score \< 15 at the time of incident assessed retrospectively by participant)
* significant untreated medical illness
* history of neurological disorder
* history of any pervasive developmental disorder
* history of bipolar disorder
* history of psychotic disorder
* alcohol/substance abuse or dependence within the last 3 months
* extensive narcotic use
* current participation in counselling more extensive than supportive therapy (e.g., exposure therapy, Cognitive-Behavioural Therapy would be an exclusion)
* a degree of mental distress that is unlikely to benefit from a short-term therapy (for our participants' well-being, it will be necessary that we believe it possible to safely address the issues/triggers brought up in treatment within the 8 sessions).

Where this trial is running

London, Ontario

• London Health Sciences Centre - University Hospital — London, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Ruth A Lanius, MD, PhD — London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
• Study coordinator: Suzy - Study Coordinator

Conditions: PTSD, Post-traumatic Stress Disorder, Deep Brain Reorienting, DBR