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

NCT ID: NCT00947999

Last Updated: 2013-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 93 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-10-31

Brief Summary

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.

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.

Conditions

Spinal Cord Injury; Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Craig H. Neilsen Foundation

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Mark Jensen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark P Jensen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22801188 (View on PubMed)

Other Identifiers

124155-A

Identifier Type: -

Identifier Source: secondary_id

36292-D Phase I

Identifier Type: -

Identifier Source: org_study_id