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

NCT02178917 | Completed

• 1 other identifier: GN14NE311
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Intensity of Pain

  As measured by a numerical analogue scale

  1 year

Secondary Outcomes (4)

• Changes in EEG activity

  1 year

• Changes in Spasticity

  1 year

• Changes in Mood

  1 year

• Changes in quality of sleep

  1 year

Study Arms (3)

patients with central neuropathic pain

EXPERIMENTAL

Randomised to 20 neurofeedback therapy sessions

Other: Neurofeedback therapy

Control: patients with central neuropathic pain

OTHER

Randomised to no neurofeedback treatment

Other: No neurofeedback therapy

patients with no central neuropathic pain

NO INTERVENTION

Observed for development of central neuropathic pain

Interventions

Neurofeedback therapy OTHER

patients with central neuropathic pain

No neurofeedback therapy OTHER

Control: patients with central neuropathic pain

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Central Neuropathic Pain (Treatment and Control Groups)
• Normal or corrected to normal vision
• No history of brain disease or injury
• Incomplete/complete spinal cord injury at level C5 to T12
• Below level neuropathic pain for at least 6 weeks
• Intensity of pain 4 or above (verbal numeric scale - VNS)
• Stable medication regime responding to some extent to CNP medication treatment
• Patients with no chronic pain
• Normal or corrected to normal vision
• No history of brain disease or injury
• Incomplete/complete injury at level C5 to T12
• Within 23 months post-injury

You may not qualify if:

• Patients with Central Neuropathic Pain (Control and Treatment Groups)
• Chronic or acute muscular or visceral pain larger than 4 VNS.
• Epilepsy
• Diagnosed mental health problems
• Active intervention of pain team
• Patients with no chronic pain
• Chronic or acute pain larger than 3 on the VNS.
• Epilepsy
• Diagnosed mental health problems

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

Queen Elizabeth National Spinal Injuries Unit, Southern General Hospital

Glasgow, G51 4TF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29751110 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 1, 2014
• Study Start: August 27, 2014
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

GB (1)