- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00947999
Neurofeedback Treatment of Pain in Persons With Spinal Cord Injury (SCI)
Neurofeedback Treatment of Pain in Persons With SCI: Phase 1
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
Research staff will record the brain activity of subjects by using an electroencephalogram (EEG), a device that measures the electrical activity in the brain through electrodes put on the scalp. There is no risk of electrical shock. Research staff will put a cap on the subject's head that has electrodes that will measure your brain activity. In addition to the electrodes in the cap, two electrode clips will be put on your ears. EEG activity will be collected for 20 minutes: subjects will have their eyes open for ten minutes, and then eyes closed for ten minutes.
Before the assessment, subjects will be asked how much pain they are currently in. Once the 20-minute assessment has ended, the research staff member will again ask subjects how much pain they are currently in, and how much pain they had during the EEG assessment. Subjects with SCI-related pain on a daily basis may also be contacted in the future to see if they want to participate in the second phase of this study that will involve learning to directly change their brain activity.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
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Washington
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Seattle, Washington, Yhdysvallat, 98195
- University of Washington
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Subjects will be recruited primarily from a previous survey study conducted by the principal investigator, as well as a data registry maintained by the principal investigator. Individuals recruited for these studies were recruited primarily from rehabilitation clinics. Interested individuals may also learn about the study from advertisements in newsletters and magazines from consumer organizations, physician referrals, recruitment descriptions on University of Washington websites, and study brochures in clinics.
In addition, SCI subjects participating in the study will give friends and relatives who do not have a spinal cord injury or chronic pain a brochure informing them about the study.
Kuvaus
Inclusion Criteria:
SCI Chronic Pain Group
- 18 years old or older.
- At least 12 months post-SCI.
- Otherwise healthy (i.e., no other secondary medical complications, such as pressure ulcers, that could impact pain scores).
- Read, write and understand English.
- Experience SCI-related pain on a daily basis.
- Report an average pain intensity of at least 4 on a 0-10 Numerical Scale.
- An individual must have a worst or most significant pain problem if he/she has more than one pain problem.
- Pain problem has lasted at least six months.
SCI No Pain Group
- 18 years old or older.
- At least 12 months post-SCI.
- Otherwise healthy (i.e., no other secondary medical complications, such as pressure ulcers, that could impact pain scores).
- Read, write and understand English.
Healthy Control Group
- 18 years old or older.
- Otherwise healthy (i.e., no other secondary medical complications, such as pressure ulcers, that could impact pain scores).
- Read, write and understand English.
Exclusion Criteria:
SCI Chronic Pain Group
- History of seizure activity or has non-normative brain activity.
- Suicidal or paranoid thoughts.
- Presence of traumatic brain injury or significant skull defects.
- Exhibit moderate to severe cognitive impairment (<=20) on the TICS questionnaire.
SCI No Pain Group
- History of seizure activity or has non-normative brain activity.
- Suicidal or paranoid thoughts.
- Presence of traumatic brain injury or significant skull defects.
- Experience pain more than once a week.
- Exhibit moderate to severe cognitive impairment (<=20) on the TICS questionnaire.
Healthy Control Group
- History of seizure activity or has non-normative brain activity.
- Suicidal or paranoid thoughts.
- Presence of traumatic brain injury or significant skull defects.
- Experience pain more than once a week.
- Exhibit moderate to severe cognitive impairment (<=20) on the TICS questionnaire.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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Healthy Control Group
Subjects in particular group will not have a diagnosis of SCI and do not experience chronic pain.
Subjects in this group will be matched roughly to subjects in the SCI chronic pain group based on age, gender and race/ethnicity.
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Subjects with SCI and Chronic Pain
Individuals recruited into this particular group will have a diagnosis of a spinal cord injury and experience pain on a daily basis with an average intensity of 4 out of 10 on a 0-10 scale.
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Subjects with SCI and No Chronic Pain
Subjects in particular group will have a diagnosis of SCI and not have chronic pain.
Subjects in this group will be matched roughly to subjects in the SCI chronic pain group based on age, gender and race/ethnicity.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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EEG brain wave activity.
Aikaikkuna: Recorded at time of assessment.
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Recorded at time of assessment.
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Pain intensity before, during an after EEG assessment.
Aikaikkuna: Collected at time of assessment.
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Collected at time of assessment.
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Mark P Jensen, Ph.D., University of Washington
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 36292-D Phase I
- 124155-A
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