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

Study Overview
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Brief Summary
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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.

Official Title
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Neurofeedback Treatment of Central Neuropathic Pain (CNP) in Sub-acute Patients With Spinal Cord Injury (SCI)

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Other: Neurofeedback therapy
* Other: No neurofeedback therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with central neuropathic pain<br>Randomised to 20 neurofeedback therapy sessions | Other: Neurofeedback therapy<br> <br> |
| Other: Control: patients with central neuropathic pain<br>Randomised to no neurofeedback treatment | Other: No neurofeedback therapy<br> <br> |
| No Intervention: patients with no central neuropathic pain<br>Observed for development of central neuropathic pain | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of Pain | As measured by a numerical analogue scale | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in EEG activity |  | 1 year | 
| Changes in Spasticity | Modified Ashworth Scale and patellar reflex | 1 year | 
| Changes in Mood |  | 1 year | 
| Changes in quality of sleep | Medical Outcomes Study (MOS) Sleep Scale | 1 year |