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
  Purpose

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.


Condition
Spinal Cord Injury
Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Neurofeedback Treatment of Pain in Persons With SCI: Phase 1

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • EEG brain wave activity. [ Time Frame: Recorded at time of assessment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain intensity before, during an after EEG assessment. [ Time Frame: Collected at time of assessment. ] [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: July 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947999

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
The Craig H. Neilsen Foundation
Investigators
Principal Investigator: Mark P Jensen, Ph.D. University of Washington
  More Information

Publications:
Responsible Party: Mark Jensen, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00947999     History of Changes
Other Study ID Numbers: 36292-D Phase I, 124155-A
Study First Received: July 27, 2009
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014