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Completed

NCT Number: NCT01012635

Chronic Pain and Brain Activity in Spinal Cord Injury

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Washington

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Hypnosis

Other

Hypnosis Training: Verbal suggestions from an audio recording (via headphones).

Meditation

Other

Meditation: focus on a single word ("one") for the entire session.

Neurofeedback training

Other

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 names: biofeedback

Two different levels of tDCS

Other

Direct stimulation of the brain by using a weak electrical current. There is no risk of electrical shock.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Cortical Modulation of Chronic Pain

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 13, 2009
Registry last updated
Jan 16, 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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