Chronic Pain and Brain Activity in Spinal Cord Injury

NCT01012635 | Completed DMC

• 2 other identifiers: 36127-B1R21HD058049-01A2
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; chronic pain

Outcome Measures

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.

  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 (2)

• Study procedures will result in changes in the EEG (electroencephalogram) assessment.

  Post procedure EEG (electroencephalogram) assessment is completed right after each study procedure

• 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.

Study Arms (1)

Neurofeedback, tDCS (2 levels), Self-hypnosis, Meditation

Other: Hypnosis; Other: Meditation; Other: Neurofeedback training; Other: Two different levels of tDCS

Interventions

Hypnosis OTHER

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

Neurofeedback, tDCS (2 levels), Self-hypnosis, Meditation

Meditation OTHER

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

Neurofeedback, tDCS (2 levels), Self-hypnosis, Meditation

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.

Also known as: biofeedback

Neurofeedback, tDCS (2 levels), Self-hypnosis, Meditation

Two different levels of tDCS OTHER

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

Neurofeedback, tDCS (2 levels), Self-hypnosis, Meditation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosed with Spinal Cord Injury
• years of age or older
• Daily pain
• At least 12 months since injury
• Read speak and understand English

You may not qualify if:

• History of seizure disorder or non-normative brain activity
• Presence of traumatic brain injury or significant skull defects
• Exhibit moderate to severe cognitive impairment

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Chronic Pain

Interventions

Hypnosis; Meditation; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Feedback, Psychological

Study Officials

• Mark P. Jensen, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 13, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

US (1)