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

Primary Purpose

Spinal Cord Injuries, Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Neurofeedback
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Neurofeedback

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  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 one significant pain problem that is the worst or most painful if he/she has more than one pain problem.
  8. Pain problem has lasted at least six months, and began after injury.

Exclusion Criteria:

  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.

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurofeedback

Arm Description

See Intervention description below.

Outcomes

Primary Outcome Measures

Average daily (past 24 hours) pain will be the primary outcome measure for the clinical phase of this study. This will be assessed using a 0-10 NRS via four phone interviews performed on different days by a research assistant.

Secondary Outcome Measures

Brain wave activity will be assessed in all of second phase participants with the use of an electroencephalogram(EEG).
Sleep quality will be assessed using the six-item Medical Outcomes Study Sleep measure(Hays & Stewart, 1992).
Pain interference will be assessed using the PROMIS Pain Impact Scale.
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS; Krupp et al., 1998). The FSS is a 9-item measure assessing both fatigue severity and impact.
Medication use in the week prior to each assessment including medication use as well as pain treatments such as massage.
Benefits received from treatment.

Full Information

First Posted
July 27, 2009
Last Updated
June 4, 2013
Sponsor
University of Washington
Collaborators
The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00977041
Brief Title
Neurofeedback Treatment of Pain in Persons With Spinal Cord Injury (SCI)
Official Title
Neurofeedback Treatment of Pain in Persons With SCI: Phase 2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
The Craig H. Neilsen Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A number of studies suggest that training to increase different types of brain waves is related to pain relief. The purpose of the second phase of this study is to see if neurofeedback training might help people with chronic pain control their pain better. The information from the study may help the investigators treat chronic pain better in the future.
Detailed Description
During this phase of the study, research personnel will provide up to 15 of the subjects with SCI-related pain with a full course (up to 40 sessions) of NF training to determine the effects of this treatment on (a) chronic daily pain, (b) EEG-assessed frequency band amplitudes, and (c) other measures of quality of life (specifically, sleep quality, fatigue, and pain interference). Standard NF training procedures will be used that involve simply asking participants to relax while looking at the feedback screen and to "Do whatever is necessary to make and keep the color bar wide." EEG bandwidth activity that is associated with being pain-free or with experiencing less pain will be reinforced. This protocol will be repeated for up to 40 30-minute sessions, scheduled at least weekly (but more often if the participant and study PI can arrange this with their schedules. Brain wave activity will be measured three times during the study: once before treatment begins, once immediately after treatment ends, and three months following treatment. Research staff will collect data regarding pain intensity and quality of life from subjects via the telephone three times: before treatment, immediately after treatment, and three months after treatment ends.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Pain
Keywords
Neurofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurofeedback
Arm Type
Experimental
Arm Description
See Intervention description below.
Intervention Type
Behavioral
Intervention Name(s)
Neurofeedback
Intervention Description
Electrodes will be placed over the temporal lobes bilaterally and a ground electrode placed on the left earlobe. EEG activity will be amplified using a Procomp 2 or Nexus amplifier, and EEGer software will be used to provide subjects with feedback. Contingencies will be set such that alpha brain activity will be reinforced, and high beta and theta brain activity will be inhibited. Standard NF training procedures will be used, which involve simply asking subjects to relax while looking at the feedback screen and "Do whatever is necessary to make and keep the bar wide." This protocol will be repeated for up to 40 60-minute sessions (that will include 30 minutes of NF training), scheduled at least weekly.
Primary Outcome Measure Information:
Title
Average daily (past 24 hours) pain will be the primary outcome measure for the clinical phase of this study. This will be assessed using a 0-10 NRS via four phone interviews performed on different days by a research assistant.
Time Frame
Just before treatment begins, just after treatment ends (approximately 1 to 6 months following the beginning of treatment), and 3 months following the end of treatment.
Secondary Outcome Measure Information:
Title
Brain wave activity will be assessed in all of second phase participants with the use of an electroencephalogram(EEG).
Time Frame
EEG activity will be collected just before the first treatment session (baseline), just after the last treatment session, and three months following the end of treatment.
Title
Sleep quality will be assessed using the six-item Medical Outcomes Study Sleep measure(Hays & Stewart, 1992).
Time Frame
Just before treatment begins, just after treatment ends (approximately 1 to 6 months following the beginning of treatment), and 3 months following the end of treatment.
Title
Pain interference will be assessed using the PROMIS Pain Impact Scale.
Time Frame
Just before treatment begins, just after treatment ends (approximately 1 to 6 months following the beginning of treatment), and 3 months following the end of treatment.
Title
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS; Krupp et al., 1998). The FSS is a 9-item measure assessing both fatigue severity and impact.
Time Frame
Just before treatment begins, just after treatment ends (approximately 1 to 6 months following the beginning of treatment), and 3 months following the end of treatment.
Title
Medication use in the week prior to each assessment including medication use as well as pain treatments such as massage.
Time Frame
Just before treatment begins, just after treatment ends (approximately 1 to 6 months following the beginning of treatment), and 3 months following the end of treatment.
Title
Benefits received from treatment.
Time Frame
Following the end of treatment (approximately 1 to 6 months after treatment begins) and 3 months following the end of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old or older. At least 12 months post-SCI. Otherwise healthy (i.e., no other secondary medical complications, such as pressure ulcers, that could impact pain scores). Read, write and understand English. Experience SCI-related pain on a daily basis. Report an average pain intensity of at least 4 on a 0-10 Numerical Scale. An individual must have one significant pain problem that is the worst or most painful if he/she has more than one pain problem. Pain problem has lasted at least six months, and began after injury. Exclusion Criteria: History of seizure activity or has non-normative brain activity. Suicidal or paranoid thoughts. Presence of traumatic brain injury or significant skull defects.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark P Jensen, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23532434
Citation
Jensen MP, Gertz KJ, Kupper AE, Braden AL, Howe JD, Hakimian S, Sherlin LH. Steps toward developing an EEG biofeedback treatment for chronic pain. Appl Psychophysiol Biofeedback. 2013 Jun;38(2):101-8. doi: 10.1007/s10484-013-9214-9.
Results Reference
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Neurofeedback Treatment of Pain in Persons With Spinal Cord Injury (SCI)

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