Improving Dysregulated Neural Networks With EEG-neurofeedback

NCT06587919 | Enrolling By Invitation FDA Device

• 1 other identifier: 93533245
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Comorbid PTSD in the context of chronic pain rehabilitation is a major problem. The lack of effective and efficient methods that can be integrated into current practice is needed. The current recommended treatments for PTSD leave room for supplementary approaches to achieve symptom reduction. PTSD is characterized by specific alterations of neural activity, and the DMN is known to be involved in this. Neurofeedback is the most current approach to altering neural activity patterns towards a norm pattern found in healthy subjects. The aim of the present study is to assess whether EEG neurofeedback compared to an active control group receiving EEG sham neurofeedback is effective in alleviating PTSD symptoms and pain intensity in patients with chronic pain and comorbid PTSD after MVCs.

Conditions

Chronic Pain; Ptsd

Keywords

EEG; neurofeedback; pain; ptsd

Outcome Measures

Primary Outcomes (2)

• Pain intensity rating

  Average pain intensity during the last day and current pain intensity before beginning the neurofeedback session, will be assessed on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain)

  Before every nf-session and six months after the last session.

• EEG-power in alpha band

  37-channel EEG will be recorded, the alpha power seems to indicate cortical activity.

  Before the first nf-session and after the last session (roughly six weeks later)

Secondary Outcomes (1)

• General QoL

  Assessed before first nf-session, after five weeks and after seven months.

Study Arms (2)

Real EEG-NF

ACTIVE COMPARATOR

10 EEG based neurofeedback sessions modulating the activity of the default mode network.

Device: Neurofeedback

Sham EEG-NF

SHAM COMPARATOR

10 sessions of neurofeedback another person's EEG.

Device: Neurofeedback

Interventions

Neurofeedback DEVICE

EEG-based neurofeedback, administered with the Neuroguide software.

Real EEG-NF; Sham EEG-NF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• has finished treatment at Smertecenter Syd.
• is still experiencing pain of more than 4 on the Numeric Ranking Scale (NRS).
• has been exposed to an adverse event that causes continued arousal according to the International Trauma Questionnaire.

You may not qualify if:

• Participants with known neurological disorders will be excluded from participation.

Sponsors & Collaborators

• University of Southern Denmark: lead
• Imaging future: collaborator

Study Sites (1)

University of Southern Denmark

Odense, 5230, Denmark

Location

Related Publications (11)

• Sterling M, Hendrikz J, Kenardy J, Kristjansson E, Dumas JP, Niere K, Cote J, deSerres S, Rivest K, Jull G. Assessment and validation of prognostic models for poor functional recovery 12 months after whiplash injury: a multicentre inception cohort study. Pain. 2012 Aug;153(8):1727-1734. doi: 10.1016/j.pain.2012.05.004. Epub 2012 Jun 1.

  PMID: 22658881 BACKGROUND

• Siqveland J, Hussain A, Lindstrom JC, Ruud T, Hauff E. Prevalence of Posttraumatic Stress Disorder in Persons with Chronic Pain: A Meta-analysis. Front Psychiatry. 2017 Sep 14;8:164. doi: 10.3389/fpsyt.2017.00164. eCollection 2017.

  PMID: 28959216 BACKGROUND

• Sharp TJ, Harvey AG. Chronic pain and posttraumatic stress disorder: mutual maintenance? Clin Psychol Rev. 2001 Aug;21(6):857-77. doi: 10.1016/s0272-7358(00)00071-4.

  PMID: 11497210 BACKGROUND

• Ravn SL, Hartvigsen J, Hansen M, Sterling M, Andersen TE. Do post-traumatic pain and post-traumatic stress symptomatology mutually maintain each other? A systematic review of cross-lagged studies. Pain. 2018 Nov;159(11):2159-2169. doi: 10.1097/j.pain.0000000000001331.

  PMID: 29994992 BACKGROUND

• Ipser J, Seedat S, Stein DJ. Pharmacotherapy for post-traumatic stress disorder - a systematic review and meta-analysis. S Afr Med J. 2006 Oct;96(10):1088-96.

  PMID: 17164942 BACKGROUND

• Craig A, Tran Y, Guest R, Gopinath B, Jagnoor J, Bryant RA, Collie A, Tate R, Kenardy J, Middleton JW, Cameron I. Psychological impact of injuries sustained in motor vehicle crashes: systematic review and meta-analysis. BMJ Open. 2016 Sep 8;6(9):e011993. doi: 10.1136/bmjopen-2016-011993.

  PMID: 27609849 BACKGROUND

• Buitenhuis J, de Jong PJ, Jaspers JP, Groothoff JW. Relationship between posttraumatic stress disorder symptoms and the course of whiplash complaints. J Psychosom Res. 2006 Nov;61(5):681-9. doi: 10.1016/j.jpsychores.2006.07.008.

  PMID: 17084147 BACKGROUND

• Bradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry. 2005 Feb;162(2):214-27. doi: 10.1176/appi.ajp.162.2.214.

  PMID: 15677582 BACKGROUND

• Andersen TE, Ravn SL, Armfield N, Maujean A, Requena SS, Sterling M. Trauma-focused cognitive behavioural therapy and exercise for chronic whiplash with comorbid posttraumatic stress disorder: a randomised controlled trial. Pain. 2021 Apr 1;162(4):1221-1232. doi: 10.1097/j.pain.0000000000002117.

  PMID: 33086286 BACKGROUND

• Andersen TE, Lahav Y, Ellegaard H, Manniche C. A randomized controlled trial of brief Somatic Experiencing for chronic low back pain and comorbid post-traumatic stress disorder symptoms. Eur J Psychotraumatol. 2017 May 30;8(1):1331108. doi: 10.1080/20008198.2017.1331108. eCollection 2017.

  PMID: 28680540 BACKGROUND

• Andersen TE, Ellegaard H, Schiottz-Christensen B, Mejldal A, Manniche C. Somatic Experiencing(R) for patients with low back pain and comorbid posttraumatic stress symptoms - a randomised controlled trial. Eur J Psychotraumatol. 2020 Aug 18;11(1):1797306. doi: 10.1080/20008198.2020.1797306.

  PMID: 33029333 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Stress Disorders, Post-Traumatic; Pain

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Tonny Elmose Andersen, PhD

  Professor at Institute of Psychology, SDU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: September 23, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)