Neurofeedback Treatment of Pain in Persons With Spinal Cord Injury (SCI)

This study has been completed.
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
Mark Jensen, University of Washington
ClinicalTrials.gov Identifier:
NCT00947999
First received: July 27, 2009
Last updated: June 4, 2013
Last verified: October 2011

July 27, 2009
June 4, 2013
July 2009
October 2011   (final data collection date for primary outcome measure)
EEG brain wave activity. [ Time Frame: Recorded at time of assessment. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00947999 on ClinicalTrials.gov Archive Site
Pain intensity before, during an after EEG assessment. [ Time Frame: Collected at time of assessment. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Neurofeedback Treatment of Pain in Persons With Spinal Cord Injury (SCI)
Neurofeedback Treatment of Pain in Persons With SCI: Phase 1

There has been little research on how chronic pain is related to brain activity. The purpose of this study is to learn more about pain and brain activity by finding any differences in brain activity among people who have moderate to severe chronic pain and a spinal cord injury, those who have a spinal cord injury but do not experience chronic pain, and people who have neither a spinal cord injury nor chronic pain (please note: subjects do not have to have pain to participate in this study). The information we collect will help the investigators get a better understanding of chronic pain.

Research staff will record the brain activity of subjects by using an electroencephalogram (EEG), a device that measures the electrical activity in the brain through electrodes put on the scalp. There is no risk of electrical shock. Research staff will put a cap on the subject's head that has electrodes that will measure your brain activity. In addition to the electrodes in the cap, two electrode clips will be put on your ears. EEG activity will be collected for 20 minutes: subjects will have their eyes open for ten minutes, and then eyes closed for ten minutes.

Before the assessment, subjects will be asked how much pain they are currently in. Once the 20-minute assessment has ended, the research staff member will again ask subjects how much pain they are currently in, and how much pain they had during the EEG assessment. Subjects with SCI-related pain on a daily basis may also be contacted in the future to see if they want to participate in the second phase of this study that will involve learning to directly change their brain activity.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Subjects will be recruited primarily from a previous survey study conducted by the principal investigator, as well as a data registry maintained by the principal investigator. Individuals recruited for these studies were recruited primarily from rehabilitation clinics. Interested individuals may also learn about the study from advertisements in newsletters and magazines from consumer organizations, physician referrals, recruitment descriptions on University of Washington websites, and study brochures in clinics.

In addition, SCI subjects participating in the study will give friends and relatives who do not have a spinal cord injury or chronic pain a brochure informing them about the study.

  • Spinal Cord Injury
  • Pain
Not Provided
  • Healthy Control Group
    Subjects in particular group will not have a diagnosis of SCI and do not experience chronic pain. Subjects in this group will be matched roughly to subjects in the SCI chronic pain group based on age, gender and race/ethnicity.
  • Subjects with SCI and Chronic Pain
    Individuals recruited into this particular group will have a diagnosis of a spinal cord injury and experience pain on a daily basis with an average intensity of 4 out of 10 on a 0-10 scale.
  • Subjects with SCI and No Chronic Pain
    Subjects in particular group will have a diagnosis of SCI and not have chronic pain. Subjects in this group will be matched roughly to subjects in the SCI chronic pain group based on age, gender and race/ethnicity.
Jensen MP, Sherlin LH, Gertz KJ, Braden AL, Kupper AE, Gianas A, Howe JD, Hakimian S. Brain EEG activity correlates of chronic pain in persons with spinal cord injury: clinical implications. Spinal Cord. 2013 Jan;51(1):55-8. doi: 10.1038/sc.2012.84. Epub 2012 Jul 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

SCI Chronic Pain Group

  1. 18 years old or older.
  2. At least 12 months post-SCI.
  3. Otherwise healthy (i.e., no other secondary medical complications, such as pressure ulcers, that could impact pain scores).
  4. Read, write and understand English.
  5. Experience SCI-related pain on a daily basis.
  6. Report an average pain intensity of at least 4 on a 0-10 Numerical Scale.
  7. An individual must have a worst or most significant pain problem if he/she has more than one pain problem.
  8. Pain problem has lasted at least six months.

SCI No Pain Group

  1. 18 years old or older.
  2. At least 12 months post-SCI.
  3. Otherwise healthy (i.e., no other secondary medical complications, such as pressure ulcers, that could impact pain scores).
  4. Read, write and understand English.

Healthy Control Group

  1. 18 years old or older.
  2. Otherwise healthy (i.e., no other secondary medical complications, such as pressure ulcers, that could impact pain scores).
  3. Read, write and understand English.

Exclusion Criteria:

SCI Chronic Pain Group

  1. History of seizure activity or has non-normative brain activity.
  2. Suicidal or paranoid thoughts.
  3. Presence of traumatic brain injury or significant skull defects.
  4. Exhibit moderate to severe cognitive impairment (<=20) on the TICS questionnaire.

SCI No Pain Group

  1. History of seizure activity or has non-normative brain activity.
  2. Suicidal or paranoid thoughts.
  3. Presence of traumatic brain injury or significant skull defects.
  4. Experience pain more than once a week.
  5. Exhibit moderate to severe cognitive impairment (<=20) on the TICS questionnaire.

Healthy Control Group

  1. History of seizure activity or has non-normative brain activity.
  2. Suicidal or paranoid thoughts.
  3. Presence of traumatic brain injury or significant skull defects.
  4. Experience pain more than once a week.
  5. Exhibit moderate to severe cognitive impairment (<=20) on the TICS questionnaire.
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00947999
36292-D Phase I, 124155-A
No
Mark Jensen, University of Washington
University of Washington
The Craig H. Neilsen Foundation
Principal Investigator: Mark P Jensen, Ph.D. University of Washington
University of Washington
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP