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Completed

NCT Number: NCT00977041

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Washington

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurofeedback

Behavioral

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 outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Official study title

Neurofeedback Treatment of Pain in Persons With SCI: Phase 2

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 15, 2009
Registry last updated
Jun 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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