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
  Purpose

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 Intervention
Spinal Cord Injury
Other: Hypnosis
Other: Meditation
Other: Neurofeedback training
Other: Two different levels of tDCS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cortical Modulation of Chronic Pain

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012635

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Mark P. Jensen, PhD University of Washington
  More Information

No publications provided

Responsible Party: Mark Jensen, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01012635     History of Changes
Other Study ID Numbers: 36127-B, 1R21HD058049-01A2
Study First Received: October 30, 2009
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 20, 2014