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

Pain Clinical Trial

Official title:

Neurofeedback Treatment of Pain in Persons With SCI: Phase 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947999
• Other study ID #: 36292-D Phase I
• Secondary ID: 124155-A
• Status: Completed
• Phase: N/A
• First received: July 27, 2009
• Last updated: June 4, 2013
• Start date: July 2009
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pain
• Spinal Cord Injuries
• Spinal Cord Injury

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG brain wave activity.		Recorded at time of assessment.	No
Secondary	Pain intensity before, during an after EEG assessment.		Collected at time of assessment.	No