Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

Chronic Pain Clinical Trial

— RELEARN  

Official title:

Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05335486
• Other study ID #: RELEARN2200701
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: October 5, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: February 2024
• Source: Redo-Neurosystems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Knee Pain
• Chronic Pain
• Musculoskeletal Pain
• Osteoarthritis

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.

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

Locations

Country	Name	City	State
Denmark	Center for Clinical Research	Hjørring

Sponsors (2)

Lead Sponsor	Collaborator
Redo-Neurosystems	North Denmark Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in pain characteristics	Pain characteristics (MPQ and WOMAC)	Up to 6 month
Secondary	Change in consumption of analgesics	Consumption of analgesics (MQS-III)	Up to 6 month
Secondary	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