Brain stimulation to reduce pain following spinal cord injury

Not Applicable

Completed

• Conditions: europathic spinal cord injury pain; Neuropathic spinal cord injury pain; Anaesthesiology - Pain management; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12609000071224
• Lead Sponsor: Prof Philip Siddall

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Complete thoracic spinal cord injury (American Spinal Injury Association (ASIA) Impairment Scale (AIS) A)
6 or more months following injury
Medically stable
Persistent neuropathic pain present for more than 6 months which is moderate to severe in intensity (greater than or equal to 4/10 on a numerical rating scale)
Must give informed consent to participate in the study

Exclusion Criteria

Intellectual or mental impairment preventing full understanding of the risks and benefits of participating and/or obtaining informed consent
Subjects who have metal objects in their body, anxiety disorders, such as claustrophobia, panic attacks or any psychiatric disorder may be excluded

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain severity as assessed by administration of the International Spinal Cord Injury Basic Pain Dataset and/or Neuropathic Pain Scale[At baseline, prior to and after each period of intervention, days 1-5 of each treatment week and at 10 weeks and 6 months after intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Functional independence as assessed by administration of the Spinal Cord Independence Measure (SCIM III)[At baseline, prior to and after each period of intervention and at 10 weeks and 6 months after intervention commencement];Mood as assessed by administration of the Beck Depression Inventory[At baseline, prior to and after each period of intervention and at 10 weeks and 6 months after intervention commencement];Patient global impression of change (PGIC)[At baseline, prior to and after each period of intervention and at 10 weeks and 6 months after intervention commencement];Measurements of brain changes using MRI techniques[At baseline, prior to and after each period of intervention and at 10 weeks and 6 months after intervention commencement]