Text Size

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:
NCT00977041
First received: July 27, 2009
Last updated: October 24, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injuries
Pain
 Behavioral: Neurofeedback
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neurofeedback Treatment of Pain in Persons With SCI: Phase 2

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

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. [ 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neurofeedback
See Intervention description below.
 Behavioral: Neurofeedback
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977041

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
The Craig H. Neilsen Foundation
Investigators
Principal Investigator: Mark P Jensen, Ph.D. University of Washington
  More Information

No publications provided

Responsible Party: Mark Jensen, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00977041     History of Changes
Other Study ID Numbers: 36292-D Phase 2, 124155
Study First Received: July 27, 2009
Last Updated: October 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Neurofeedback

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 May 23, 2013