Neurofeedback Treatment of Pain in Persons With Spinal Cord Injury (SCI)
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.
Spinal Cord Injury
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Neurofeedback Treatment of Pain in Persons With SCI: Phase 1|
- EEG brain wave activity. [ Time Frame: Recorded at time of assessment. ] [ Designated as safety issue: No ]
- Pain intensity before, during an after EEG assessment. [ Time Frame: Collected at time of assessment. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947999
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Mark P Jensen, Ph.D.||University of Washington|