Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain (RELEARN)

This clinical investigation will be carried out as a randomized controlled trial conducted at the Northern Regional Hospital, Hjørring. This investigation will enrol 36 patients suffering from severe knee osteoarthritis pain, primarily from the orthopaedic ward at Hjørring Hospital, where potential participants will be identified during routine consultations.

The RELEARN intervention consists of encephalography (EEG) neurofeedback of cerebral movement evoked signatures of pain, where the participants will be instructed in attempting to manipulate these signatures to reduce pain perception. This investigation is carried out to analyse the clinical performance and safety of the RELEARN neurofeedback software.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis; Chronic Pain; Chronic Knee Pain
• Intervention / Treatment: Device: RELEARN Neurofeedback; Other: Standard care control

Detailed Description

The participants will be randomized into treatment group A and control group B, 1:1 and be stratified based on age, sex, and ethnicity. Group A participants will be asked to attend eight sessions of RELEARN neurofeedback with an approximate duration of 45 minutes per session, and group B participants will be asked to attend eight sessions with no intervention and serve as no-treatment controls with an approximate duration of 5 minutes per session. Both groups (A and B) will undergo three follow-up sessions: one month, three months, and five months post intervention.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Morten Kirkegaard, MSc; Phone Number: +4520468932; Email: mk@redoneurosystems.com

Study Locations

• Denmark
  • Hjørring, Denmark, 9800
    • Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-65 years old
2. Knee arthrosis (Kellgren-Lawrence score of ≥ 2)
3. 24h VAS ≥ 4

4. Ongoing pain, lasting more than three months

   Exclusion Criteria:

   Participants who meet any of the below criteria will be excluded from the investigation:

5. Pregnant or lactating woman
6. Use of opioids or cannabis
7. Active drug addiction defined as the use of cannabis, opioids, or other drugs
8. Previous or current neurologic, systemic, or mental illness, including any liver, kidney or metabolic disease.
9. Rheumatoid arthritis
10. Evidence of other pain types such as visceral, neuropathic, or malignant pain.
11. Evidence of other sources of ongoing pain such as root affect, traumas, or congenital malformation
12. Severe inflammation in the area of interest
13. Blindness or deafness
14. Consumption of alcohol, caffeine, nicotine on test day
15. Recent history of fractures or surgery in the area of interest
16. Participation in other clinical trials throughout the study period and one month prior to participation
17. History of epilepsy
18. Obesity class III and above. I.e. BMI > 39,9

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RELEARN - Intervention; Intervention group participants will be seen at the orthopedic ward and receive standard care for knee osteoarthrosis, defined by Danish clinical guidelines. In addition, intervention group participants will be asked to attend eight sessions of RELEARN neurofeedback with an approximate duration of 45 minutes per session. Also, participants will undergo three follow-up sessions: one month, three months, and five months post-intervention	Device: RELEARN Neurofeedback; Standard care + The RELEARN intervention. Intervention group participants will be seen at the orthopedic ward and receive standard care for knee osteoarthrosis, defined by Danish clinical guidelines. During standard care, intervention group participants will be subject to the RELEARN intervention, consisting of encephalography (EEG) neurofeedback of cerebral movement evoked signatures of pain, where the participants will be instructed in attempting to manipulate these signatures to reduce pain perception.
Active Comparator: Standard care control; Standard Care control. Control group participants will be seen at the orthopedic ward and receive standard care for knee osteoarthrosis, defined by Danish clinical guidelines. During standard care, the control group participants will be asked to attend eight control sessions with no RELEARN intervention with an approximate duration of 5 minutes per session. Also, participants will undergo three follow-up sessions: one month, three months, and five months post-intervention	Other: Standard care control; Standard Care control. Control group participants will be seen at the orthopedic ward and receive standard care for knee osteoarthrosis, defined by Danish clinical guidelines. During standard care, the control group participants will be asked to attend eight control sessions with no RELEARN intervention with an approximate duration of 5 minutes per session. Also, participants will undergo three follow-up sessions: one month, three months, and five months post-intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Pain Perception	Change in the 10-point Visual Analogue Scale (VAS) over time (0 = no pain, 10 = maximum imaginable pain)	Up to 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	QoL (EQ-5D), Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).	Up to 6 month
Change in pain characteristics	Pain characteristics (MPQ and WOMAC)	Up to 6 month
Change in consumption of analgesics	Consumption of analgesics (MQS-III)	Up to 6 month
Evaluate the safety of the RELEARN software by assessment of adverse events and device deficiencies	Incidence of AE/ADE/SAE/SADE/DD	Up to 6 month

Collaborators and Investigators

• Sponsor: Redo-Neurosystems
• Collaborators: North Denmark Regional Hospital
• Investigators: Principal Investigator: Peter Christian Leutscher, Dr. PhD, Center of Clinical Research, Regional Hospital North Jutland, Hjørring, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: chronic pain; Osteoarthritis; Neuroplasticity; EMG; EEG; Neurofeedback; Pain perception; Chronic Knee Pain; Movement evoked potentials
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Muscular Diseases; Osteoarthritis; Chronic Pain; Musculoskeletal Pain
• Other Study ID Numbers: RELEARN2200701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No