Recruiting

Deep Brain Reorienting

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT04317820

Conditions

PTSD

Post-traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Deep Brain Reorienting (DBR)

Study Details

Brief summary:

This study will evaluate the efficacy of a therapeutic treatment, Deep Brain Reorienting (DBR), for PTSD (Post-traumatic Stress Disorder). Participants will be randomized to either the DBR treatment, or wait-list condition.

While enrollment for the first phase of the study has ended, a second phase has begun, which focuses on DBR treatment in military veterans.

Conditions

PTSD

Post-traumatic Stress Disorder

Study ID

NCT04317820

Start date

Sep 29, 2020

Status verified date

Oct, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • military veteran
  • 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:

  • not a military veteran
  • 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).

Study Design

Enrollment

234 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DBR Condition

Involves 8 weekly sessions of DBR treatment.

no intervention: Wait-list Condition

No intervention for approximately 8 weeks.

Interventions

Deep Brain Reorienting (DBR)

Trauma processing through DBR involves bringing up a traumatic memory and encouraging the client to focus on tensions arising in the muscles of the shoulders, neck, head and face (i.e., those involved in orienting toward a threatening person/event). The rationale is as follows: Physiologically, orienting to a stimulus, whether external or in the mind's eye, comes before any affective response to it. Here, it is hypothesized that there is activity in certain midbrain structures , i.e.,Superior Colliculi (SC) and Periaqueductal Gray (PAG). The deep layers of the SC bring on a brief (orienting) tension in the neck as well as preparing for eye movements, which is later followed by the processing of raw affect in the PAG. In session, if we can attend to this tension - even if we have to backtrack from the emotion that follows - we can establish an anchor in the body that precedes the affect and is hypothesized to protect against emotional overwhelm.

Primary outcome measure

  • change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale (CAPS) at post-treatment assessment [ Time Frame: 8 weeks ]
  • change in PTSD symptoms from post-treatment assessment as measured by the Clinician Administered PTSD Scale (CAPS) at follow-up assessment [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Suzy - Study Coordinator

519-685-8500Suzy.Southwell@lhsc.on.ca

Locations

London Health Sciences Centre - University Hospital

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Suzy -Study Coordinator

519-685-8500suzy.southwell@lhsc.on.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Keywords

  • Deep Brain Reorienting
  • DBR
  • military
  • veterans

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.