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Neurofeedback Treatment of Pain in Persons With Spinal Cord Injury (SCI)

4. juni 2013 oppdatert av: Mark Jensen, University of Washington

Neurofeedback Treatment of Pain in Persons With SCI: Phase 1

There has been little research on how chronic pain is related to brain activity. The purpose of this study is to learn more about pain and brain activity by finding any differences in brain activity among people who have moderate to severe chronic pain and a spinal cord injury, those who have a spinal cord injury but do not experience chronic pain, and people who have neither a spinal cord injury nor chronic pain (please note: subjects do not have to have pain to participate in this study). The information we collect will help the investigators get a better understanding of chronic pain.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

93

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Washington
      • Seattle, Washington, Forente stater, 98195
        • University of Washington

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

Inclusion Criteria:

SCI Chronic Pain Group

  1. 18 years old or older.
  2. At least 12 months post-SCI.
  3. Otherwise healthy (i.e., no other secondary medical complications, such as pressure ulcers, that could impact pain scores).
  4. Read, write and understand English.
  5. Experience SCI-related pain on a daily basis.
  6. Report an average pain intensity of at least 4 on a 0-10 Numerical Scale.
  7. An individual must have a worst or most significant pain problem if he/she has more than one pain problem.
  8. Pain problem has lasted at least six months.

SCI No Pain Group

  1. 18 years old or older.
  2. At least 12 months post-SCI.
  3. Otherwise healthy (i.e., no other secondary medical complications, such as pressure ulcers, that could impact pain scores).
  4. Read, write and understand English.

Healthy Control Group

  1. 18 years old or older.
  2. Otherwise healthy (i.e., no other secondary medical complications, such as pressure ulcers, that could impact pain scores).
  3. Read, write and understand English.

Exclusion Criteria:

SCI Chronic Pain Group

  1. History of seizure activity or has non-normative brain activity.
  2. Suicidal or paranoid thoughts.
  3. Presence of traumatic brain injury or significant skull defects.
  4. Exhibit moderate to severe cognitive impairment (<=20) on the TICS questionnaire.

SCI No Pain Group

  1. History of seizure activity or has non-normative brain activity.
  2. Suicidal or paranoid thoughts.
  3. Presence of traumatic brain injury or significant skull defects.
  4. Experience pain more than once a week.
  5. Exhibit moderate to severe cognitive impairment (<=20) on the TICS questionnaire.

Healthy Control Group

  1. History of seizure activity or has non-normative brain activity.
  2. Suicidal or paranoid thoughts.
  3. Presence of traumatic brain injury or significant skull defects.
  4. Experience pain more than once a week.
  5. Exhibit moderate to severe cognitive impairment (<=20) on the TICS questionnaire.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.
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.
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
EEG brain wave activity.
Tidsramme: Recorded at time of assessment.
Recorded at time of assessment.

Sekundære resultatmål

Resultatmål
Tidsramme
Pain intensity before, during an after EEG assessment.
Tidsramme: Collected at time of assessment.
Collected at time of assessment.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Washington

Samarbeidspartnere

The Craig H. Neilsen Foundation

Etterforskere

  • Hovedetterforsker: Mark P Jensen, Ph.D., University of Washington

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2009

Primær fullføring (Faktiske)

1. oktober 2011

Studiet fullført (Faktiske)

1. oktober 2011

Datoer for studieregistrering

Først innsendt

27. juli 2009

Først innsendt som oppfylte QC-kriteriene

28. juli 2009

Først lagt ut (Anslag)

29. juli 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. juni 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. juni 2013

Sist bekreftet

1. oktober 2011

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 36292-D Phase I
  • 124155-A

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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