Clinical trial NCT02678494: Brain-Train Home Based Pain Treatment
Official title: Home Based Brain-Train Treatment of Central Neuropathic Pain Following Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: Spinal Cord Injury
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study examining the effectiveness of neurofeedback therapy for the treatment of Central Neuropathic Pain (CNP), in patients with a Spinal Cord Injury, using a small user-friendly device which can be operated by patients at home.

Detailed description: Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation from 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% to 40% of SCI patients, severe CNP affects their everyday living including sleep and mood. Medical treatment of CNP is moderately effective and costly, both to the patient and to the health care system.

In a previous study, some characteristic 'signatures' of brain waves that are related to CNP were 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 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. Costly laboratory devices were used and once the study was over, an adequate alternative could not be offered to patients.

In this study, a cheap, portable, wireless and user friendly, Conformité Européenne (CE) marked EEG device will be used to train 10 patients to self-administer the therapy in the comfort of their homes. Participants will be given initial training to use the equipment then will be asked to use the system at home for 3 months - initially, 3-5 times a week then, if/when pain subsides, at least once a week or as required.

The primary purpose of the study is to determine whether a portable system for neuromodulation is a useful tool for administering therapy for pain (intensity of pain will be measured by the visual numerical scale (VNS)).

The secondary purpose of the study is a quantitative analysis of changes in the brain activity due to therapy, as measured by EEG; patients' perspective of the home based neuro-therapy (assessed by questionnaires and one-to-one, semi-structured interviews).

Eligibility criteria: Inclusion Criteria:

* normal or corrected to normal vision
* no history of brain disease or injury
* incomplete/complete injury at level C5 to T12
* central neuropathic pain (below the level of injury)
* intensity of pain 4 or above (VNS)
* stable medication regime (expected not to change during the period of the study), responding to some extent to CNP medication treatment
* patient or caregiver minimum computer literacy (owning a computer, laptop, tablet, ipad etc)

Exclusion Criteria:

* chronic or acute muscular or visceral pain larger than 4 VNS
* epilepsy
* diagnosed mental health problems
* active intervention of pain team (changing existing treatments)

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Brain activity
timeFrame: Baseline and 3 months
measure: Patients' perspective of home-based neuro-therapy training
timeFrame: 3 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth National Spinal Injuries Unit
Study officials:
affiliation: University of Glasgow
name: Aleksandra Vuckovic, Dipl Ing MSc PhD
role: PRINCIPAL_INVESTIGATOR
References: