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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178917
• Other study ID #: GN14NE311
• Status: Completed
• Phase: N/A
• Start date: August 27, 2014
• Est. completion date: November 29, 2017

Study information

• Verified date: February 2019
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Patients with Central Neuropathic Pain (Treatment and Control Groups)

1. Normal or corrected to normal vision

2. No history of brain disease or injury

3. Incomplete/complete spinal cord injury at level C5 to T12

4. Below level neuropathic pain for at least 6 weeks

5. Intensity of pain 4 or above (verbal numeric scale - VNS)

6. Stable medication regime responding to some extent to CNP medication treatment

Patients with no chronic pain

1. Normal or corrected to normal vision

2. No history of brain disease or injury

3. Incomplete/complete injury at level C5 to T12

4. Within 23 months post-injury

Exclusion Criteria:

Patients with Central Neuropathic Pain (Control and Treatment Groups)

1. Chronic or acute muscular or visceral pain larger than 4 VNS.

2. Epilepsy

3. Diagnosed mental health problems

4. Active intervention of pain team

Patients with no chronic pain

1. Chronic or acute pain larger than 3 on the VNS.

2. Epilepsy

3. Diagnosed mental health problems

Related Conditions & MeSH terms

• Neuralgia
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Other:
• Neurofeedback therapy

• No neurofeedback therapy

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth National Spinal Injuries Unit, Southern General Hospital	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of Pain	As measured by a numerical analogue scale	1 year
Secondary	Changes in EEG activity		1 year
Secondary	Changes in Spasticity	Modified Ashworth Scale and patellar reflex	1 year
Secondary	Changes in Mood		1 year
Secondary	Changes in quality of sleep	Medical Outcomes Study (MOS) Sleep Scale	1 year