Deep Brain Reorienting in Post-traumatic Stress Disorder
The Effects of Deep Brain Reorienting (DBR) on Post-traumatic Stress Disorder (PTSD)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Suzy - Study Coordinator
- Phone Number: 35186 519-685-8500
- Email: Suzy.Southwell@lhsc.on.ca
Study Locations
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Ontario
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre - University Hospital
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: DBR Condition
Involves 8 weekly sessions of DBR treatment.
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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.
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No Intervention: Wait-list Condition
No intervention for approximately 8 weeks.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale (CAPS) at post-treatment assessment
Time Frame: 8 weeks
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min.
CAPS score=0, max=80, with higher scores representing greater PTSD symptoms
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8 weeks
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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
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min.
CAPS score=0, max=80, with higher scores representing greater PTSD symptoms
|
3 months
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Ruth A Lanius, MD, PhD, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 8997
- 114501 (Other Identifier: Western University's Human Research Ethics)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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