Chronic Pain and Brain Activity in Spinal Cord Injury

NCT ID: NCT01012635

Last Updated: 2013-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Hypnosis

Intervention Type OTHER

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

Meditation

Intervention Type OTHER

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

Neurofeedback training

Intervention Type 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.

Two different levels of tDCS

Intervention Type OTHER

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

Interventions

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Hypnosis

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

Intervention Type OTHER

Meditation

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

Intervention Type 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.

Intervention Type OTHER

Two different levels of tDCS

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

Intervention Type OTHER

Other Intervention Names

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biofeedback

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Mark Jensen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark P. Jensen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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1R21HD058049-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

36127-B

Identifier Type: -

Identifier Source: org_study_id

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