Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00977041
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : June 6, 2013
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
Mark Jensen, University of Washington

Tracking Information
First Submitted Date  ICMJE July 27, 2009
First Posted Date  ICMJE September 15, 2009
Last Update Posted Date June 6, 2013
Study Start Date  ICMJE August 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2011)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
Average daily (past 24 hours) below-level neuropathic 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 3 months to one year after treatment begins), and 3 months following the end of treatment (approximately 6 months to 15 months after treatment begins). ]
Change History Complete list of historical versions of study NCT00977041 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2011)
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
  • 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) and just after the last treatment session(approximately 3 months to one year after treatment begins). ]
  • 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 3 months to one year after treatment begins), and 3 months following the end of treatment (approximately 6 months to 15 months after treatment begins). ]
  • Pain interference will be assessed using the modified Brief Pain Inventory BPI; Cleeland and Ryan, 1994; modified so that the "interference with walking" item asks about "interference with mobility." [ Time Frame: Just before treatment begins, just after treatment ends (approximately 3 months to one year after treatment begins), and 3 months following the end of treatment (approximately 6 months to 15 months after treatment begins). ]
  • 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 3 months to one year after treatment begins), and 3 months following the end of treatment (approximately 6 months to 15 months after treatment begins). ]
  • Analgesic 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 3 months to one year after treatment begins), and 3 months following the end of treatment (approximately 6 months to 15 months after treatment begins). ]
  • Benefits received from treatment. [ Time Frame: Following the end of treatment (approximately 3 months to one year after treatment begins). ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurofeedback Treatment of Pain in Persons With Spinal Cord Injury (SCI)
Official Title  ICMJE Neurofeedback Treatment of Pain in Persons With SCI: Phase 2
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injuries
  • Pain
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Neurofeedback
See Intervention description below.
Intervention: Behavioral: Neurofeedback
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2013)
13
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2009)
15
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00977041
Other Study ID Numbers  ICMJE 36292-D Phase 2
124155
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark Jensen, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE The Craig H. Neilsen Foundation
Investigators  ICMJE
Principal Investigator: Mark P Jensen, Ph.D. University of Washington
PRS Account University of Washington
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP