NCT04654130

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 21, 2022

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

November 27, 2020

Last Update Submit

February 10, 2022

Conditions

PTSDPost-traumatic Stress DisorderCognitive DysfunctionCognitive Deficit

Keywords

neurofeedbackICNintrinsic connectivity networksdefault mode networksalience network

Outcome Measures

Primary Outcomes (4)

  • Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment.

    Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms

    19 weeks

  • Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment.

    Gold standard, clinician-administered PTSD assessment tool; min. score=0, max.=80, with higher scores representing greater PTSD symptoms

    12 weeks

  • Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment

    A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.

    19 weeks

  • Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment

    A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.

    12 weeks

Study Arms (2)

Neurofeedback (NFB)

EXPERIMENTAL

Participants in the NFB condition will complete 19 weekly sessions of NFB from home with research staff supervision (via videoconferencing), and pre-, post- and 3-month follow-up assessments.

Other: Neurofeedback

Wait List

NO INTERVENTION

Participants in the Wait List condition will receive no NFB for approximately 31 weeks, and will be asked to complete pre-, post- and 3-month follow-up assessments. After study completion, they will be offered the same 19 weeks of NFB.

Interventions

NeurofeedbackOTHER

NFB is a type of brain training in which a person is given real-time information (or feedback) from their own brain activities to help them potentially change how their brain is functioning (i.e., to work in a healthier or more effective manner). In the current study, we will implement at-home, supervised (via teleconferencing) neurofeedback sessions using the Muse headband paired with the Myndlift software application to conduct "alpha-down" neurofeedback once per week, for 19 weeks.

Also known as: EEG Biofeedback
Neurofeedback (NFB)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (4)

  • 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.

    PMID: 24266644BACKGROUND

  • 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.

    PMID: 32658503BACKGROUND

  • 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.

    PMID: 33395981BACKGROUND

  • 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.

    PMID: 30004602BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticCognitive DysfunctionCognition Disorders

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Ruth Lanius, MD, PhD

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2020

First Posted

December 4, 2020

Study Start

February 1, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

February 21, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Only coded data will be shared with co-investigators who are registered with the study's ethics board application.

Locations

CA(1)