- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01298609
Occipital Nerve (C2) Stimulation in the Treatment of Fibromyalgia
A Randomized Controlled Pilot Study to Examine the Efficacy of Greater Occipital Nerve (C2) Stimulation in the Treatment of Fibromyalgia
The study is designed as a prospective, randomized, double-blind, single center study with a 6 month duration post permanent system implantation. Forty patients will be implanted.
During trial stimulation, patients will be randomized into one of two study arms for two weeks. Crossover will occur at the 2 week study visit to the opposite group. After completion of these two arms, every patient will subsequently complete participation in the third study arm.
After completion of the third arm, patients will be evaluated to determine if they are a positive responder responder. If so, the patient will have the option of obtaining the permanent implant.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Antwerpen, Belgia
- Universitair Ziekenhuis Antwerpen
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients able to provide informed consent to participate in the study;
- Patient has had chronic widespread pain for at least 3 months in all 4 body quadrants;
- Patient has at least 11 out of 18 tender points based on the tender points examination;
- Patient has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to drugs, physical therapy, acupuncture, etc.);
- Patient medication has remained stable for at least 4 weeks prior to baseline data collection;
- Psychological screening has been completed and the patient has been cleared by a psychologist as a suitable study candidate;
- Patient agrees not to add or increase medication throughout the randomization trial period of the study;
- Patient is willing to cooperate with the study requirements including compliance with the treatment regimen and completion of all office visits.
Exclusion Criteria:
- Patient has current evidence of any psychiatric disorder, as documented by the DSM-IV-TR criteria with psychotic characteristics, (e.g. bipolar disorder, major depressive disorder);
- Patient has been diagnosed with any disease mimicking the symptoms of the Fibromyalgia Syndrome (e.g. Epstein Barr, autoimmune diseases, etc.) that is not currently being treated or has not been stable for at least 6 months;
- Patient is currently in active menopause;
- Patient has been diagnosed with sleep apnea and is not currently involved in a treatment regime;
- Patient has a history of substance abuse or substance dependency in the past 6 months prior to baseline data collection;
- Patient currently participating in another clinical study;
- Patient with demand-type cardiac pacemakers, an infusion pump or any implantable neurostimulator device;
- Patient is likely to require an MRI evaluation in the future;
- Patient is not willing to maintain current medication regimen;
- Female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Suprathreshold Stimulation
Patients will be stimulated at supra-sensory threshold levels for two weeks using occipital stimulation
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Occipital Nerve Stimulation will be used in each study arm using the Eon Mini neuromodulation system
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Sham-komparator: minimal stimulation
Patients will be stimulated at minimal stimulation for two weeks using occipital stimulation
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Occipital Nerve Stimulation will be used in each study arm using the Eon Mini neuromodulation system
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Aktiv komparator: Subthreshold Stimulation
Patients will be stimulated at sub-sensory threshold stimulation for two weeks using occipital stimulation
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Occipital Nerve Stimulation will be used in each study arm using the Eon Mini neuromodulation system
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Fibromyalgia Impact Questionnaire (FIQ)
Tidsramme: End of 6 week stimulation trial
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The Fibromyalgia Impact Questionnaire (FIQ) is a self administered scale that was developed to measure fibromyalgia patient status, progress and outcomes. It measures the components of health that are most affected by fibromyalgia. The maximum score is 100 and a higher score indicates a greater impact of the syndrome on the person. The change in the Fibromyalgia Impact Questionnaire (FIQ) will be analyzed and reported. |
End of 6 week stimulation trial
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CRD_545
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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University of AberdeenFullførtFibromyalgi | Fibromyalgi, primær | Fibromyalgi, sekundærStorbritannia
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Cairo UniversityHar ikke rekruttert ennå
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Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases...Fullført
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University of UtahAvsluttet
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State University of New York - Upstate Medical...FullførtFibromyalgi, primærForente stater
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University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloFullført
Kliniske studier på Occipital Stimulation
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IRCCS Sacro Cuore Don Calabria di NegrarFullført
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Rush University Medical CenterJohns Hopkins UniversityTilbaketrukketOccipital nevralgi | Posttraumatisk nevralgiForente stater
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MedtronicNeuroFullførtKronisk migrene hodepineForente stater, Canada, Storbritannia
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Southern Medical University, ChinaRekrutteringChiari misdannelse | Basilar invaginasjon | Atlantoaksial dislokasjonKina
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Alberta Health Services, CalgaryRekruttering
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Assiut UniversityUkjentCervikal ustabilitet Ryggraden
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Aydin Adnan Menderes UniversityRekrutteringBlokkere | Kronisk migrene, hodepine | Occipital nevralgiTyrkia
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Keimyung University Dongsan Medical CenterRekruttering
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Riphah International UniversityRekrutteringNakkesmertepasienter med tetthet i hamstringPakistan