Chronic Pain and Brain Activity in Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Cortical Modulation of Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012635
• Other study ID #: 36127-B
• Secondary ID: 1R21HD058049-01A
• Status: Completed
• Phase: N/A
• First received: October 30, 2009
• Last updated: January 14, 2013
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Other:
• Hypnosis
Hypnosis Training: Verbal suggestions from an audio recording (via headphones).
• Meditation
Meditation: focus on a single word ("one") for the entire session.
• 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.
• Two different levels of tDCS
Direct stimulation of the brain by using a weak electrical current. There is no risk of electrical shock.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		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	No
Secondary	Study procedures will result in changes in the EEG (electroencephalogram) assessment.	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.	Post procedure EEG (electroencephalogram) assessment is completed right after each study procedure	No
Secondary	The observed changes in EEG (electroencephalogram) bandwidth activity associated with these procedures will mediate the decreases in pain intensity.		Changes in the EEG (electroencephalogram) completed after each procedure will be related to the amount of pain relief experienced.	No