Skip to main content
Clinical Trials/NCT05335486
NCT05335486WithdrawnPhase 2

Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

Redo-Neurosystems2 sites in 1 countryStarted: October 5, 2022Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Withdrawn
Sponsor
Locations
2
Primary Endpoint
Changes in Pain Perception

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18-65 years old
  • Knee arthrosis (Kellgren-Lawrence score of ≥ 2)
  • 24h VAS ≥ 4
  • Ongoing pain, lasting more than three months

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Changes in Pain Perception

Time Frame: Up to 6 month

Change in the 10-point Visual Analogue Scale (VAS) over time (0 = no pain, 10 = maximum imaginable pain)

Secondary Outcomes

  • Change in consumption of analgesics(Up to 6 month)
  • Change in quality of life(Up to 6 month)
  • Change in pain characteristics(Up to 6 month)
  • Evaluate the safety of the RELEARN software by assessment of adverse events and device deficiencies(Up to 6 month)

Investigators

Sponsor
Redo-Neurosystems
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials