Clinical trial NCT04654130: Neurofeedback Effectiveness Trial in PTSD
Official title: An Effectiveness Trial Examining Neurofeedback in Adults With PTSD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PTSD
Post-traumatic Stress Disorder
Cognitive Dysfunction
Cognitive Deficit
Keywords: neurofeedback
ICN
intrinsic connectivity networks
default mode network
salience network
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: McMaster University
name: FDC Foundation
First posted: 2020-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an effectiveness trial investigating neurofeedback as an intervention for both symptoms of PTSD, and the commonly associated cognitive impairment/dysfunction (e.g., attention, executive function, processing speed). Participants will be randomized to one of two conditions: NFB or Wait List.
Primary purpose: TREATMENT

Brief summary: This study is an effectiveness trial investigating neurofeedback (NFB) in adults with PTSD (Post-Traumatic Stress Disorder). Participants will be randomly assigned to one of two treatment conditions - i) NFB, or ii) wait list. Due to the coronavirus pandemic, our study will, primarily, take place online (i.e., online assessment and treatment, with option of in-person fMRI, or functional magnetic resonance imaging, scans). NFB sessions will be conducted from home, with videoconferenced supervision by research staff. After study completion, individuals in the wait list condition will be offered the same NFB treatment.

Detailed description: PTSD has an emotional impact on individuals, but it is also associated with impaired cognitive functioning (e.g., processing speed, attention, executive functioning). Unfortunately, there is little research investigating both issues simultaneously. The current study is an effectiveness trial for an intervention called neurofeedback (NFB), which may be helpful in addressing both PTSD symptom severity, and cognitive dysfunction. NFB is a type of brain training in which a person is given real-time information (or feedback) from their own brain activity to help them potentially change how their brain is functioning (i.e., to work in a healthier or more effective manner). NFB has been in use for over 30 years, and it is proven to be quite effective in treating ADHD (Attention Deficit Hyperactivity Disorder); however, it has not been embraced as a clinical intervention for other mental health disorders. Recent systematic reviews of NFB suggest that this treatment intervention can lead to significant clinical improvements (e.g., reduction in PTSD severity), and it can impact both functional brain activity and cognitive function. The current study hopes to bring these 3 areas of interest together by investigating the impact of NFB on PTSD symptoms, cognitive ability, and intrinsic neurological connectivity (via fMRI - function magnetic imaging).

In the current study, participants will be randomized into one of two conditions: NFB or Wait List. Those in the NFB condition will begin 19 weekly, supervised (via teleconferencing) sessions of NFB, while the Wait List will not receive NFB for approximately 31 weeks (i.e., not until final assessments are complete). After all assessments are complete, participants in the Wait List condition will be able to begin the same 19 sessions of NFB. Study participation includes pre-, post-, and 3-month follow-up assessments, and 2 optional fMRI scans. Due to the current coronavirus pandemic, this study will be conducted primarily online.

Eligibility criteria: Inclusion Criteria:

* primary diagnosis of PTSD as determined by our pre-treatment assessment
* Due to online nature: must have access to (and ability to use) a computer/tablet with a working microphone and camera (or webcam) for assessments, and a tablet/smartphone for NFB, reliable access to a secure internet connection, and access to a quiet, private space for the assessments and sessions.
* Ability to provide informed consent
* Fluency in written and spoken English
* must be resident of Ontario (due to restrictions of professional licenses)

Exclusion Criteria for those opting in to fMRI scan:

* any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety standards (e.g., pacemaker, pregnancy/possible pregnancy)

Exclusion Criteria for study in general:

* history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score \< 15 at the time of incident as assessed retrospectively by participant)
* significant untreated medical illness
* history of neurological or neurodevelopmental disorder
* history of any pervasive developmental disorder
* any medical disorder known to adversely affect cognition within the last 12 months
* lifetime bipolar or psychotic disorder
* alcohol/substance abuse or dependence within the last 3 months
* extensive narcotic use (e.g., fentanyl, oxycodone, etc.), use of anti-cholinergics, anti-psychotics, psychostimulants, or benzodiazepines
* ECT (electroconvulsive therapy) within the last 12 months
* significant dissociative disorder (as determined by our baseline assessment)
* suicide attempt in last 6 months
* pregnancy (due to impact of hormones on cognitive abilities)
* hearing or vision issues that would interfere with effective online participation:

Primary outcomes:
measure: Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment.
timeFrame: 19 weeks
measure: Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment.
timeFrame: 12 weeks
measure: Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment
timeFrame: 19 weeks
measure: Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Ruth Lanius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kluetsch RC, Ros T, Theberge J, Frewen PA, Calhoun VD, Schmahl C, Jetly R, Lanius RA. Plastic modulation of PTSD resting-state networks and subjective wellbeing by EEG neurofeedback. Acta Psychiatr Scand. 2014 Aug;130(2):123-36. doi: 10.1111/acps.12229. Epub 2013 Nov 25.
citation: Rogel A, Loomis AM, Hamlin E, Hodgdon H, Spinazzola J, van der Kolk B. The impact of neurofeedback training on children with developmental trauma: A randomized controlled study. Psychol Trauma. 2020 Nov;12(8):918-929. doi: 10.1037/tra0000648. Epub 2020 Jul 13.
citation: Nicholson AA, Ros T, Densmore M, Frewen PA, Neufeld RWJ, Theberge J, Jetly R, Lanius RA. A randomized, controlled trial of alpha-rhythm EEG neurofeedback in posttraumatic stress disorder: A preliminary investigation showing evidence of decreased PTSD symptoms and restored default mode and salience network connectivity using fMRI. Neuroimage Clin. 2020;28:102490. doi: 10.1016/j.nicl.2020.102490. Epub 2020 Nov 5.
citation: Nicholson AA, Rabellino D, Densmore M, Frewen PA, Paret C, Kluetsch R, Schmahl C, Theberge J, Ros T, Neufeld RWJ, McKinnon MC, Reiss JP, Jetly R, Lanius RA. Intrinsic connectivity network dynamics in PTSD during amygdala downregulation using real-time fMRI neurofeedback: A preliminary analysis. Hum Brain Mapp. 2018 Nov;39(11):4258-4275. doi: 10.1002/hbm.24244. Epub 2018 Jul 13.