Brain-Train Home Based Pain Treatment

Neuropathic Pain Clinical Trial

Official title:

Home Based Brain-Train Treatment of Central Neuropathic Pain Following Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678494
• Other study ID #: GN15NE124
• Status: Completed
• Phase: N/A
• Start date: June 9, 2016
• Est. completion date: November 1, 2017

Study information

• Verified date: August 2017
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Spinal Cord Injuries

Intervention

Other:
• Neurofeedback training

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth National Spinal Injuries Unit	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Change in intensity of pain as measured by the Visual Numerical Scale	Baseline and 3 months
Secondary	Brain activity	Change in brain activity as measured by EEG	Baseline and 3 months
Secondary	Patients' perspective of home-based neuro-therapy training	Qualitative assessment of patient's perspective of treatment as assessed by questionnaire and one-to-one semi-structured interview	3 months