Chronic Pain and Brain Activity in Spinal Cord Injury

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark Jensen, University of Washington
ClinicalTrials.gov Identifier:
NCT01012635
First received: October 30, 2009
Last updated: January 14, 2013
Last verified: January 2013

October 30, 2009
January 14, 2013
December 2009
December 2011   (final data collection date for primary outcome measure)
Current pain intensity after each study procedure will be the primary outcome measure. This pain intensity will be assessed using a 0 - 10 Numerical Rating Scale during the EEG (electroencephalogram) assessment after each intervention. [ Time Frame: Ratings of current and of average, worst, and least pain intensity "during the past five minutes" will be obtained every 5 min during each of the EEG (electroencephalogram) assessments ] [ Designated as safety issue: No ]
Current pain intensity after each study procedure will be the primary outcome measure. This pain intensity will be assessed using a 0 - 10 Numerical Rating Scale during the EEG assessment after each intervention. [ Time Frame: Ratings of current and of average, worst, and least pain intensity "during the past five minutes" will be obtained every 5 min during each of the EEG assessments ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01012635 on ClinicalTrials.gov Archive Site
  • Study procedures will result in changes in the EEG (electroencephalogram) assessment. [ Time Frame: Post procedure EEG (electroencephalogram) assessment is completed right after each study procedure ] [ Designated as safety issue: No ]
    Specifically these procedures will induce greater relative increases in alpha [7-12 Hz] bandwidth activity and greater relative decreases in beta (14-33 Hz) bandwidth activity, then either of the two control conditions.
  • The observed changes in EEG (electroencephalogram) bandwidth activity associated with these procedures will mediate the decreases in pain intensity. [ Time Frame: Changes in the EEG (electroencephalogram) completed after each procedure will be related to the amount of pain relief experienced. ] [ Designated as safety issue: No ]
  • A single session of NF, HYP, and tDCS will result in changes in the EEG. Specifically these procedures will induce greater increases in alpha bandwidth activity and greater decreases in beta bandwidth activity, then either of the two control conditions. [ Time Frame: Approximately one year after procedure sessions ] [ Designated as safety issue: No ]
  • The observed changes in EEG bandwidth activity associated with NF, HYP, and tDCS will mediate the decreases in pain intensity. [ Time Frame: Approximately one year after procedure sessions ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Chronic Pain and Brain Activity in Spinal Cord Injury
Cortical Modulation of Chronic Pain

This study compares five different procedures to see how they affect pain and brain activity. The procedures include neurofeedback, self-hypnosis training, meditation, and two different levels of transcranial direct current stimulation (tDCS). Subjects will be compensated for their time.

During the first study visit, subjects will receive a physical exam and an electroencephalogram (EEG), which measures brain activity. Research staff will put a cap on your head that has sensors which measure your brain activity. There is no risk of electrical shock. In addition to the sensors in the cap, two clips will be put on your ears. EEG activity will be collected for 20 minutes: you will have your eyes open for ten minutes, and then have your eyes closed for ten minutes.

Additional study visits will follow where we will perform five different procedures (neurofeedback, self-hypnosis, two levels of transcranial direct current stimulation, and meditation). All subjects will receive all five procedures and each procedure will be conducted for 20 minutes.

Self-Hypnosis Training: You will be given verbal suggestions from an audio recording (via headphones) for relaxation and changes in the way you think about pain.

Meditation: You will be asked to focus on a single word ("one") for the entire session.

Neurofeedback Training: During this procedure, three sensors will be placed on your scalp, and one on each earlobe. A small amount of electrode paste will be used when placing the sensor on your scalp. There is no risk of electrical shock. You will be able to see images on a computer screen that correspond to your brain waves. You will learn how to change your brainwaves by changing the images on the computer.

Electric Stimulation (two different levels): This procedure consists of direct stimulation of the brain by a weak electrical current. The two procedure sessions will differ in the characteristics of the stimulation. Two electrodes will be placed on your scalp and secured by a rubber strap. The tDCS procedure is considered experimental and is not currently approved by the FDA but has been studied previously, at the same level of current, in spinal cord injury.

Before and after each procedure we will complete a 10 minutes EEG assessment similar to what is described above. The final procedure session will end with a 20 minute assessment to determine how responsive you are to hypnosis. Each procedure visits may last up to three hours. There will be a total of 6 study visits over approximately 2 months.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Subjects may be referred by their personal physician or enrolled after seeing recruitment flyers or brochures. Subjects will be recruited from a previous survey study conducted by the principal investigator, as well as a data registry maintained by the principal investigator. Individuals recruited from these studies were recruited primarily from rehabilitation clinics.

Spinal Cord Injury
  • Other: Hypnosis
    Hypnosis Training: Verbal suggestions from an audio recording (via headphones).
  • Other: Meditation
    Meditation: focus on a single word ("one") for the entire session.
  • Other: Neurofeedback training
    Neurofeedback Training: Two electrodes will be placed on your scalp, and one electrode clipped on your head. There is no risk of electrical shock.
    Other Name: biofeedback
  • Other: Two different levels of tDCS
    Direct stimulation of the brain by using a weak electrical current. There is no risk of electrical shock.
Neurofeedback, tDCS (2 levels), Self-hypnosis, Meditation
Interventions:
  • Other: Hypnosis
  • Other: Meditation
  • Other: Neurofeedback training
  • Other: Two different levels of tDCS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with Spinal Cord Injury
  • 18 years of age or older
  • Daily pain
  • At least 12 months since injury
  • Read speak and understand English

Exclusion Criteria:

  • History of seizure disorder or non-normative brain activity
  • Presence of traumatic brain injury or significant skull defects
  • Exhibit moderate to severe cognitive impairment
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01012635
36127-B, 1R21HD058049-01A2
Yes
Mark Jensen, University of Washington
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Mark P. Jensen, PhD University of Washington
University of Washington
January 2013

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