Deep Brain Reorienting in Post-traumatic Stress Disorder

NCT ID: NCT04317820

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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This study will evaluate the efficacy of Deep Brain Reorienting (DBR) in reducing PTSD symptoms. DBR was designed by Dr. Frank Corrigan, a Scottish psychiatrist interested in the brain mechanisms underlying effective trauma psychotherapy. For this study, participants will be randomized to either the DBR treatment or wait-list study conditions. Trauma processing through DBR involves bringing up a traumatic memory and encourages 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). It is believed that this approach will allow the participant to process the traumatic memory in an emotionally manageable way, changing how it is represented/accessed in the brain's innate defensive system. Online Stream - Assessments will include clinical interviews (pre/post treatment, and follow-up) using Webex video conferencing, and fMRI (functional magnetic resonance imaging) scans (pre/post treatment). In-Person Stream - Assessment will include clinical interviews (pre/post treatment and follow-up), and fMRI scans (pre/post treatment).

Conditions

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PTSD Post-traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to either the DBR treatment or wait-list conditions.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Only the outcome assessors will be blinded to which condition the participant was assigned.

Study Groups

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DBR Condition

Involves 8 weekly sessions of DBR treatment.

Group Type EXPERIMENTAL

Deep Brain Reorienting (DBR)

Intervention Type BEHAVIORAL

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.

Wait-list Condition

No intervention for approximately 8 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Ruth Lanius

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruth A Lanius, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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London Health Sciences Centre - University Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

References

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Corneil BD, Munoz DP, Chapman BB, Admans T, Cushing SL. Neuromuscular consequences of reflexive covert orienting. Nat Neurosci. 2008 Jan;11(1):13-5. doi: 10.1038/nn2023. Epub 2007 Dec 2.

Reference Type BACKGROUND
PMID: 18059264 (View on PubMed)

Lanius RA, Rabellino D, Boyd JE, Harricharan S, Frewen PA, McKinnon MC. The innate alarm system in PTSD: conscious and subconscious processing of threat. Curr Opin Psychol. 2017 Apr;14:109-115. doi: 10.1016/j.copsyc.2016.11.006. Epub 2016 Nov 26.

Reference Type BACKGROUND
PMID: 28813307 (View on PubMed)

Terpou BA, Densmore M, Thome J, Frewen P, McKinnon MC, Lanius RA. The Innate Alarm System and Subliminal Threat Presentation in Posttraumatic Stress Disorder: Neuroimaging of the Midbrain and Cerebellum. Chronic Stress (Thousand Oaks). 2019 Feb 5;3:2470547018821496. doi: 10.1177/2470547018821496. eCollection 2019 Jan-Dec.

Reference Type BACKGROUND
PMID: 32440590 (View on PubMed)

Comoli E, Das Neves Favaro P, Vautrelle N, Leriche M, Overton PG, Redgrave P. Segregated anatomical input to sub-regions of the rodent superior colliculus associated with approach and defense. Front Neuroanat. 2012 Apr 3;6:9. doi: 10.3389/fnana.2012.00009. eCollection 2012.

Reference Type BACKGROUND
PMID: 22514521 (View on PubMed)

Kearney BE, Corrigan FM, Frewen PA, Nevill S, Harricharan S, Andrews K, Jetly R, McKinnon MC, Lanius RA. A randomized controlled trial of Deep Brain Reorienting: a neuroscientifically guided treatment for post-traumatic stress disorder. Eur J Psychotraumatol. 2023;14(2):2240691. doi: 10.1080/20008066.2023.2240691.

Reference Type DERIVED
PMID: 37581275 (View on PubMed)

Other Identifiers

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114501

Identifier Type: OTHER

Identifier Source: secondary_id

8997

Identifier Type: -

Identifier Source: org_study_id

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