Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

NCT05335486 | Withdrawn Phase 2 DMC

• 1 other identifier: RELEARN2200701
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Knee Pain; Chronic Pain; Osteoarthritis

Keywords

chronic pain; Chronic Knee Pain; Osteoarthritis; Neurofeedback; EEG; EMG; Movement evoked potentials; Neuroplasticity; Pain perception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in quality of life

  Up to 6 month

• Change in pain characteristics

  Up to 6 month

• Change in consumption of analgesics

  Up to 6 month

• Evaluate the safety of the RELEARN software by assessment of adverse events and device deficiencies

  Up to 6 month

Study Arms (2)

RELEARN - Intervention

EXPERIMENTAL

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 control

ACTIVE COMPARATOR

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

Interventions

RELEARN Neurofeedback DEVICE

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.

RELEARN - Intervention

Standard care control OTHER

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

Standard care control

Eligibility Criteria

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

You may qualify if:

• Age 18-65 years old
• Knee arthrosis (Kellgren-Lawrence score of ≥ 2)
• h VAS ≥ 4
• Ongoing pain, lasting more than three months

You may not qualify if:

• Participants who meet any of the below criteria will be excluded from the investigation:
• Pregnant or lactating woman
• Use of opioids or cannabis
• Active drug addiction defined as the use of cannabis, opioids, or other drugs
• Previous or current neurologic, systemic, or mental illness, including any liver, kidney or metabolic disease.
• Rheumatoid arthritis
• Evidence of other pain types such as visceral, neuropathic, or malignant pain.
• Evidence of other sources of ongoing pain such as root affect, traumas, or congenital malformation
• Severe inflammation in the area of interest
• Blindness or deafness
• Consumption of alcohol, caffeine, nicotine on test day
• Recent history of fractures or surgery in the area of interest
• Participation in other clinical trials throughout the study period and one month prior to participation
• History of epilepsy
• Obesity class III and above. I.e. BMI \> 39,9

Sponsors & Collaborators

• Redo-Neurosystems: lead
• Regionshospital Nordjylland: collaborator

Study Sites (1)

Center for Clinical Research

Hjørring, 9800, Denmark

Location

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Peter Christian Leutscher, Dr. PhD

  Center of Clinical Research, Regional Hospital North Jutland, Hjørring, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised controlled study

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 19, 2022
• Study Start: October 5, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)