Chronic Pain and Brain Activity in Spinal Cord Injury

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. Identifier: NCT01012635
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : January 16, 2013
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Mark Jensen, University of Washington

Brief Summary:
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.

Condition or disease Intervention/treatment
Spinal Cord Injury Other: Hypnosis Other: Meditation Other: Neurofeedback training Other: Two different levels of tDCS

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cortical Modulation of Chronic Pain
Study Start Date : December 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Neurofeedback, tDCS (2 levels), Self-hypnosis, Meditation 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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01012635

United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Mark P. Jensen, PhD University of Washington

Responsible Party: Mark Jensen, Professor, University of Washington Identifier: NCT01012635     History of Changes
Other Study ID Numbers: 36127-B
1R21HD058049-01A2 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by Mark Jensen, University of Washington:
spinal cord injury
chronic pain

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Chronic Pain
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Signs and Symptoms