Neurofeedback for Treatment of Central Neuropathic Pain (CNP) in Sub-acute Spinal Cord Injury (SCI)

NCT ID: NCT02178917

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-27
• Study Completion Date: 2017-11-29

Brief Summary

Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body. SCI is also an indirect cause of a persistent pain, called Central Neuropathic Pain (CNP). This pain typically develops several months after the injury. In 30-40% of SCI patients, severe CNP affects their everyday living including sleep and mood. Many patients give up work, not because of the injury, but because of pain. Medical treatment of CNP is moderately effective and costly, both to the patient and to the health care system.

In previous research, characteristic 'signatures' of brain waves that are probably related to CNP have been defined. Based on this, a novel treatment for CNP based on neurofeedback was developed and clinically tested on five SCI patients. Electroencephalograph (EEG) was used to record patients' brain waves and these were shown to patients on a computer screen in a simple graphical form (e.g. bars). Patients were trained to change their brain activity at will and, as a consequence, their pain was reduced. Patients who had suffered from CNP for years received up to 40 neurofeedback treatment sessions, reducing their pain for several days after each session.

The primary aim of this study is to apply neurofeedback therapy to a larger number of recently injured patients, who are still in a hospital. It is hypothesised that neurofeedback treatment will be more effective in people who have suffered from CNP for a shorter period of time.

The secondary aim of the study is to define EEG predictors of CNP. EEG will be recorded in recently injured patients with no chronic pain, knowing that a certain number of patients will develop CNP within weeks or months. These patients will be followed up for a year and the EEGs of patients who develop CNP will be compared with those who do not.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients with central neuropathic pain

Randomised to 20 neurofeedback therapy sessions

Group Type: EXPERIMENTAL

Neurofeedback therapy

Intervention Type: OTHER

Control: patients with central neuropathic pain

Randomised to no neurofeedback treatment

Group Type: OTHER

No neurofeedback therapy

Intervention Type: OTHER

patients with no central neuropathic pain

Observed for development of central neuropathic pain

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Neurofeedback therapy

Intervention Type: OTHER

No neurofeedback therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients with Central Neuropathic Pain (Treatment and Control Groups)

1. Normal or corrected to normal vision

2. No history of brain disease or injury

3. Incomplete/complete spinal cord injury at level C5 to T12

4. Below level neuropathic pain for at least 6 weeks

5. Intensity of pain 4 or above (verbal numeric scale - VNS)

6. Stable medication regime responding to some extent to CNP medication treatment

Patients with no chronic pain

1. Normal or corrected to normal vision

2. No history of brain disease or injury

3. Incomplete/complete injury at level C5 to T12

4. Within 23 months post-injury

Exclusion Criteria

Patients with Central Neuropathic Pain (Control and Treatment Groups)

1. Chronic or acute muscular or visceral pain larger than 4 VNS.

2. Epilepsy

3. Diagnosed mental health problems

4. Active intervention of pain team

Patients with no chronic pain

1. Chronic or acute pain larger than 3 on the VNS.

2. Epilepsy

3. Diagnosed mental health problems

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Queen Elizabeth National Spinal Injuries Unit, Southern General Hospital

Glasgow, , United Kingdom

Countries

United Kingdom

References

Vuckovic A, Jajrees M, Purcell M, Berry H, Fraser M. Electroencephalographic Predictors of Neuropathic Pain in Subacute Spinal Cord Injury. J Pain. 2018 Nov;19(11):1256.e1-1256.e17. doi: 10.1016/j.jpain.2018.04.011. Epub 2018 May 8.

Reference Type: DERIVED

PMID: 29751110 (View on PubMed)

Other Identifiers

GN14NE311

Identifier Type: -

Identifier Source: org_study_id