Chronic Pain and Brain Activity in Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Chronic Pain
Study type: Observational

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.
    

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.
    

Intervention name(s): Hypnosis; Meditation; Neurofeedback training; Two different levels of tDCS
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Hypnosis Training: Verbal suggestions from an audio recording (via headphones).; Meditation: focus on a single word ("one") for the entire session.; Neurofeedback Training: Two electrodes will be placed on your scalp, and one electrode clipped on your head. There is no risk of electrical shock.; Direct stimulation of the brain by using a weak electrical current. There is no risk of electrical shock.
Other intervention name(s): biofeedback
Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: spinal cord injury; chronic pain