NCT02678494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 9, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

February 5, 2016

Last Update Submit

August 30, 2018

Conditions

Neuropathic Pain

Keywords

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Change in intensity of pain as measured by the Visual Numerical Scale

    Baseline and 3 months

Secondary Outcomes (2)

  • Brain activity

    Baseline and 3 months

  • Patients' perspective of home-based neuro-therapy training

    3 months

Study Arms (1)

Neurofeedback training

EXPERIMENTAL

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

Interventions

Neurofeedback trainingOTHER
Neurofeedback training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth National Spinal Injuries Unit

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

NeuralgiaSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Aleksandra Vuckovic, Dipl Ing MSc PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 9, 2016

Study Start

June 9, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

September 4, 2018

Record last verified: 2017-08

Locations

GB(1)