Spinal Cord InjuryNCT01012635
Chronic Pain and Brain Activity in Spinal Cord Injury
An observational study of Spinal Cord Injury, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Hypnosis, Meditation and Neurofeedback training
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosed with Spinal Cord Injury
- 18 years of age or older
- Daily pain
- At least 12 months since injury
- Read speak and understand English
Who cannot join
- History of seizure disorder or non-normative brain activity
- Presence of traumatic brain injury or significant skull defects
- Exhibit moderate to severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cortical Modulation of Chronic Pain
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Hypnosis, Meditation, Neurofeedback training, Two different levels of tDCS
- Keywords
- spinal cord injury, chronic pain
- Medical subject headings
- Spinal Cord Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
Hypnosis Training: Verbal suggestions from an audio recording (via headphones).
MeditationOther
Meditation: focus on a single word ("one") for the entire session.
Neurofeedback trainingOther
Also called biofeedback
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 tDCSOther
Direct stimulation of the brain by using a weak electrical current. There is no risk of electrical shock.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback, tDCS (2 levels), Self-hypnosis, Meditation | Not described Receives: Other: Hypnosis; Other: Meditation; Other: Neurofeedback training; Other: Two different levels of tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: Changes in the EEG (electroencephalogram) completed after each procedure will be related to the amount of pain relief experienced.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Mark Jensen, University of Washington
- Investigators
- Mark P. Jensen, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012635
- Sponsor's protocol ID
- 36127-B
- Other IDs
- 1R21HD058049-01A2
- Status last verified
- Jan 2013
- First submitted
- 30 Oct 2009
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Modulation of Chronic Pain
- ClinicalTrials.gov ID
- NCT01012635
- Acronym / sponsor ID
- 36127-B
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback, tDCS (2 levels), Self-hypnosis, Meditation | – | Other: Hypnosis, Other: Meditation, Other: Neurofeedback training, Other: Two different levels of tDCS |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Diagnosed with Spinal Cord Injury
- 18 years of age or older
- Daily pain
- At least 12 months since injury
- Read speak and understand English
Key exclusion criteria (3 listed)
- History of seizure disorder or non-normative brain activity
- Presence of traumatic brain injury or significant skull defects
- Exhibit moderate to severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnosisHypnosis Training: Verbal suggestions from an audio recording (via headphones). | Other | Neurofeedback, tDCS (2 levels), Self-hypnosis, Meditation |
| MeditationMeditation: focus on a single word ("one") for the entire session. | Other | Neurofeedback, tDCS (2 levels), Self-hypnosis, Meditation |
| Neurofeedback trainingAlso: biofeedbackNeurofeedback Training: Two electrodes will be placed on your scalp, and one electrode clipped on your head. There is no risk of electrical shock. | Other | Neurofeedback, tDCS (2 levels), Self-hypnosis, Meditation |
| Two different levels of tDCSDirect stimulation of the brain by using a weak electrical current. There is no risk of electrical shock. | Other | Neurofeedback, tDCS (2 levels), Self-hypnosis, Meditation |
Primary outcome
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
2 secondary outcomes
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark P. Jensen, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.