Deep Brain Reorienting for Post-Traumatic Stress Disorder

Overseen By Suzy - Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Must not be taking: Narcotics

Disqualifiers: Neurological disorder, Bipolar, Psychotic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Deep Brain Reorienting (DBR) to determine its effectiveness for people with Post-Traumatic Stress Disorder (PTSD). Participants will either receive the DBR treatment or be placed on a wait-list for about eight weeks. The trial aims to discover if DBR can effectively reduce PTSD symptoms. English-speaking individuals with a PTSD diagnosis who believe they might benefit from short-term trauma therapy may be a good fit for this trial.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new PTSD treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using extensive narcotics or have untreated medical illnesses, you may not be eligible to participate.

What prior data suggests that Deep Brain Reorienting is safe for treating PTSD?

Research has shown that Deep Brain Reorienting (DBR) holds promise for treating PTSD. One study found that after eight sessions, 48% of patients no longer had PTSD, and this increased to 52% three months later. These results suggest that DBR can be quite effective.

Regarding safety, studies provide limited detail about side effects or negative reactions, indicating a lack of comprehensive information on how well patients tolerate this treatment. However, since the trial is not in its early stages, there may be some confidence in its safety. It is important to consult healthcare professionals for personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Post-Traumatic Stress Disorder (PTSD), like therapy and medication, work by addressing symptoms over time. However, Deep Brain Reorienting (DBR) is unique because it directly targets the brain's response to trauma through a series of guided sessions, potentially offering a more direct path to healing. Researchers are excited about DBR because it may provide a faster and more focused way to reprocess traumatic memories, which could lead to quicker relief for those suffering from PTSD.

What evidence suggests that Deep Brain Reorienting might be an effective treatment for PTSD?

Research has shown that Deep Brain Reorienting (DBR), which participants in this trial may receive, can help treat Post-Traumatic Stress Disorder (PTSD). One study found that people who completed eight DBR sessions experienced a significant reduction in PTSD symptoms, with a 36.6% decrease immediately after treatment and a 48.6% decrease later on. Another study found that those who received DBR had fewer PTSD symptoms than those in the wait-list condition, who were awaiting treatment. Other reports noted that DBR helped reduce dissociation and similar symptoms after several sessions. These findings suggest that DBR could be a promising therapy for people with PTSD. ^{1 5 6 7 8}

Who Is on the Research Team?

Ruth A Lanius, MD, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-65 with PTSD who might gain from short-term trauma therapy. It's not for those with implants or conditions unsafe for high-strength fMRI, significant head injuries, untreated major illnesses, neurological disorders, extensive current counseling (like exposure therapy), severe mental distress unsuitable for brief treatment, developmental disorders, bipolar or psychotic history, or recent substance abuse.

Inclusion Criteria

English speaking

I have been diagnosed with PTSD by this study's assessment.

I might benefit from short-term therapy for trauma.

Exclusion Criteria

History of bipolar disorder

I have mental distress that may not improve quickly with short-term therapy.

Individuals with any implants, conditions, etc. that do not comply with 7-Tesla (7T) fMRI research safety standards (e.g., certain implants, pregnancy)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weekly sessions of Deep Brain Reorienting (DBR) treatment

8 weeks

8 visits (in-person or virtual)

Wait-list

Participants in the wait-list condition receive no intervention for approximately 8 weeks

8 weeks

Follow-up

Participants are monitored for changes in PTSD symptoms post-treatment

3 months

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• DBR

Trial Overview The study tests Deep Brain Reorienting (DBR) as a treatment for PTSD. Participants will be randomly assigned to either receive DBR therapy or placed on a wait-list as part of the control group to compare outcomes between the two sets.

How Is the Trial Designed?

Group I: DBR Condition Experimental Treatment 1 Intervention

Involves 8 weekly sessions of DBR treatment.

Group II: Wait-list Condition Active Control 1 Intervention

No intervention for approximately 8 weeks.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

This study outlines a Phase I pilot trial investigating the safety and efficacy of deep brain stimulation (DBS) targeting the basolateral amygdala in six combat veterans with severe, treatment-resistant PTSD, with a primary goal of achieving a 30% reduction in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS).

The trial design includes rigorous safety monitoring and assessments of psychiatric and neurological symptoms, aiming to gather valuable data that could inform future studies on DBS for PTSD in both veterans and non-veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation of the basolateral amygdala for treatment-refractory combat post-traumatic stress disorder (PTSD): study protocol for a pilot randomized controlled trial with blinded, staggered onset of stimulation. Koek, RJ., Langevin, JP., Krahl, SE., et al.[2023]

Deep brain stimulation (DBS) targeting the infralimbic cortex significantly improved anxiety-like behaviors and extinction deficits in rats with weak extinction responses after fear conditioning, suggesting its potential efficacy for PTSD treatment.

DBS also reversed neurocircuitry abnormalities by reducing activity in the basolateral amygdala, indicating a mechanism of action that may help restore normal fear processing in affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prefrontal Cortex Deep Brain Stimulation Improves Fear and Anxiety-Like Behavior and Reduces Basolateral Amygdala Activity in a Preclinical Model of Posttraumatic Stress Disorder. Reznikov, R., Bambico, FR., Diwan, M., et al.[2022]

Deep brain stimulation (DBS) has been explored as a treatment for PTSD, particularly in combat veterans, with promising results observed in animal models targeting specific brain areas like the medial prefrontal cortex and amygdala.

In clinical reports involving 3 patients, all showed varying degrees of improvement after receiving DBS, indicating potential efficacy, but the treatment remains investigational due to ethical concerns and challenges in recruitment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation for Post-Traumatic Stress Disorder: A Review of the Experimental and Clinical Literature. Meeres, J., Hariz, M.[2022]

Deep Brain Reorienting (DBR) significantly reduced PTSD symptoms in a clinical trial with 54 participants, showing a 36.6% reduction post-treatment and a 48.6% reduction at a three-month follow-up, compared to no significant changes in the waitlist control group.

After treatment with DBR, nearly half of the participants (48.3% post-treatment and 52.0% at follow-up) no longer met the criteria for PTSD, indicating its potential efficacy as a well-tolerated intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Deep Brain Reorienting: a neuroscientifically guided treatment for post-traumatic stress disorder. Kearney, BE., Corrigan, FM., Frewen, PA., et al.[2023]

In patients with acute PTSD, traumatic memories trigger increased activity in brain regions associated with memory and emotion, such as the amygdala and hippocampus, indicating heightened emotional responses.

The study suggests that the neurofunctional changes in acute PTSD are more widespread and unstable compared to the more defined and stable abnormalities seen in chronic PTSD, highlighting the evolving nature of the disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The neurofunctional mechanisms of traumatic and non-traumatic memory in patients with acute PTSD following accident trauma. Piefke, M., Pestinger, M., Arin, T., et al.[2011]

In a study of 98 adults at risk for PTSD, acute resting-state functional connectivity (rsFC) of the hippocampus was found to significantly predict PTSD symptom severity six months after trauma, indicating its potential as a biomarker for PTSD risk.

The study utilized advanced machine learning techniques to analyze whole-brain rsFC patterns, demonstrating that these patterns can forecast future PTSD symptoms even after accounting for other factors like baseline PTSD symptoms and levels of depression and anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hippocampal Resting-State Functional Connectivity Forecasts Individual Posttraumatic Stress Disorder Symptoms: A Data-Driven Approach. Fitzgerald, JM., Webb, EK., Weis, CN., et al.[2023]

Closed Loop Deep Brain Stimulation (CLDBS) offers a promising approach for treating psychiatric disorders by allowing real-time modulation of brain circuits based on individual physiological biomarkers, unlike Open Loop DBS which delivers fixed stimulation.

CLDBS could potentially improve conditions like PTSD and addiction by utilizing biomarkers such as skin conductance and neurotransmitter levels, paving the way for more effective treatments for previously resistant psychiatric diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed Loop Deep Brain Stimulation for PTSD, Addiction, and Disorders of Affective Facial Interpretation: Review and Discussion of Potential Biomarkers and Stimulation Paradigms. Bina, RW., Langevin, JP.[2020]

Soldiers with PTSD showed reduced cortical thickness in the frontal and temporal lobes, indicating significant structural brain changes associated with the disorder.

The study also found decreased volumes in the caudate and right hippocampus, along with enlargement in certain cerebellar lobules, suggesting that advanced neuroimaging can help in diagnosing and understanding PTSD's effects on brain anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroanatomical features in soldiers with post-traumatic stress disorder. Sussman, D., Pang, EW., Jetly, R., et al.[2019]

In a study involving 12 male veterans with PTSD and 12 without, fMRI revealed that veterans with PTSD showed underactivation in the frontal cortex and overactivation in the temporal cortex during the encoding of neutral word pairs, indicating altered brain activity related to memory processing.

During the retrieval phase, veterans with PTSD exhibited underactivation in key brain areas, including the right frontal cortex and the left posterior hippocampus, suggesting that these neural changes contribute to their memory performance deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural correlates of associative learning and memory in veterans with posttraumatic stress disorder. Geuze, E., Vermetten, E., Ruf, M., et al.[2008]

Deep brain stimulation (DBS) targeting the subgenual cingulum and uncinate fasciculus in four PTSD patients was found to be safe and showed a promising 55% reduction in PTSD symptoms as measured by the Clinical Administered PTSD Scale.

Neuroimaging revealed changes in brain activity related to PTSD, and a significant reduction in skin conductance responses during fear recall assessments after DBS suggests that this treatment may effectively alter physiological responses associated with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation of the subgenual cingulum and uncinate fasciculus for the treatment of posttraumatic stress disorder. Hamani, C., Davidson, B., Corchs, F., et al.[2022]

Research on Vietnam combat veterans with chronic PTSD suggests that prolonged exposure to high-intensity stimulation leads to significant changes in brain structure and function, particularly affecting neuronal and synaptic activity.

The study hypothesizes that these changes impair the brain's ability to regulate aggressive behavior and sleep patterns, contributing to the persistent symptoms of PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A neuropsychological hypothesis explaining posttraumatic stress disorders. Kolb, LC.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10431732/

A randomized controlled trial of Deep Brain Reorienting Eight internet-based DBR sessions resulted in significant decreases in PTSD symptoms post-treatment and at 3-month follow-up in comparison to a ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37581275/

A randomized controlled trial of Deep Brain Reorienting Eight internet-based DBR sessions resulted in significant decreases in PTSD symptoms post-treatment and at 3-month follow-up in comparison to a waitlist group.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S246874992500081X

The utilisation of deep brain reorienting (DBR) in ... After 30 respectively during 70 DBR sessions, the clients' dissociation and comorbid symptoms decreased significantly, as measured by self-assessments measures ...

4. tandfonline.com tandfonline.com/doi/abs/10.1080/20008066.2023.2240691

A randomized controlled trial of Deep Brain Reorienting These findings provide emerging evidence for the effectiveness of DBR as a well-tolerated treatment that is based on theoretical advances ...

5. withpower.com withpower.com/trial/phase-stress-disorders-traumatic-8-2020-65873

Deep Brain Reorienting for Post-Traumatic Stress Disorder Deep Brain Reorienting (DBR) significantly reduced PTSD symptoms in a clinical trial with 54 participants, showing a 36.6% reduction post-treatment and a 48.6% ...

6. psychologytoday.com psychologytoday.com/us/blog/talking-about-trauma/202411/deep-brain-reorienting-may-be-a-promising-trauma-treatment

Deep Brain Reorienting May be a Promising Trauma ... At the end of the eight sessions, 48 percent of patients no longer met the criteria for PTSD, and at a three-month follow-up, 52 percent of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S246874992500081X

The utilisation of deep brain reorienting (DBR) in ... A randomized controlled trial of Deep Brain Reorienting: A neuroscientifically guided treatment for post-traumatic stress disorder. European Journal of ...

8. trialx.com trialx.com/clinical-trials/listings/221421/deep-brain-reorienting-in-post-traumatic-stress-disorder/

Deep Brain Reorienting in Post-traumatic Stress Disorder This study will evaluate the efficacy of a therapeutic treatment, Deep Brain Reorienting (DBR), for PTSD (Post-traumatic Stress Disorder).