Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

Sponsor

Redo-Neurosystems (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05335486

Collaborator

North Denmark Regional Hospital (Other)

Enrollment

Arms

8.5

Anticipated Duration (Months)

Study Details

Study Description

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. Potential participants will be identified during routine consultations and have access to their health information.

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Knee Pain Chronic Pain Osteoarthritis	Device: RELEARN Neurofeedback	Phase 2/Phase 3

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

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised controlled studyRandomised controlled study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

Anticipated Study Start Date :

Apr 15, 2022

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RELEARN - Intervention 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 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.
No Intervention: Standard treatment control 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. Also, participants will undergo three follow-up sessions: one month, three months, and five months post-intervention

Arm

Intervention/Treatment

Experimental: RELEARN - Intervention

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

No Intervention: Standard treatment control

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. Also, participants will undergo three follow-up sessions: one month, three months, and five months post-intervention

Outcome Measures

Primary Outcome Measures

Alteration 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

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)
Change in consumption of analgesics [Up to 6 month]
Consumption of analgesics (MQS-III)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-65 years old
Be a candidate for unilateral knee arthroplasty
Suffer from medial compartment osteoarthritis
Kellgren-Lawrence score of > 2
24h VAS ≥ 6

Exclusion Criteria:

Pregnant or lactating woman
Active drug addiction defined as the use of cannabis, opioids, or other drugs
Previous or current neurologic, systemic, or mental illness
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 I and above. I.e. BMI > 30