Brain-Train Home Based Pain Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Other: Neurofeedback training

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).

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • Queen Elizabeth National Spinal Injuries Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neurofeedback training; Neurofeedback training: self-administered at home for 3 months. 3-5 sessions per week initially, then at least once a week. Each session consists of 5-6 blocks of 5 minute training.	Other: Neurofeedback training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Change in intensity of pain as measured by the Visual Numerical Scale	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain activity	Change in brain activity as measured by EEG	Baseline and 3 months
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

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Investigators: Principal Investigator: Aleksandra Vuckovic, Dipl Ing MSc PhD, University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 5, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Spinal Cord Injury
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: GN15NE124