Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

Phase 2

Withdrawn

• Conditions: Chronic Knee Pain; Chronic Pain; Osteoarthritis
• Interventions: Device: RELEARN Neurofeedback; Other: Standard care control

• Registration Number: NCT05335486
• Lead Sponsor: Redo-Neurosystems

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-19
• Study Start: 2022-10-05
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RELEARN - Intervention	RELEARN Neurofeedback	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
Standard care control	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in consumption of analgesics	Up to 6 month	Consumption of analgesics (MQS-III)
Change in quality of life	Up to 6 month	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).
Change in pain characteristics	Up to 6 month	Pain characteristics (MPQ and WOMAC)
Evaluate the safety of the RELEARN software by assessment of adverse events and device deficiencies	Up to 6 month	Incidence of AE/ADE/SAE/SADE/DD

Trial Locations

Locations (1)

Center for Clinical Research; 🇩🇰 Hjørring, Denmark