Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Efficacy of Transcranial Magnetic Stimulation (TMS) in Central Post Stroke Pain ( CPSP)

22. oktober 2018 oppdatert av: Juhani Ojala, Helsinki University Central Hospital

Efficacy of Navigated Repetitive Transcranial Magnetic Stimulation in Treatment of Central Post Stroke Pain

The aim of the study is to evaluate the analgesic effects of navigated repetitive transcranial magnetic stimulation in central post stroke pain. MRI based navigation is used to determine the exact locations for stimulation.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Central post stroke pain is often very resistant to treatment. TMS has been shown to be a promising tool in treating difficult pain conditions. The best sites for stimulation are still not known and navigation has been used only in few studies.

The aim is to evaluate the analgesic effects of Navigated Repetitive Transcranial Magnetic Stimulation ( nrTMS ) on pain in a three armed crossover study. The navigation is done by using magnetic resonance imaging and stereotactic camera system. The three arms include stimulation to M1, S2 and sham stimulation to M1. 10 Hz repetitive stimulation is given to a specified location once a day 5 days a week for two weeks in each of the three arms. A months washout period is kept between each arm of the study.

Pain and other variables are followed before, during and after the study for 6 months.

Studietype

Intervensjonell

Registrering (Faktiske)

21

Fase

  • Ikke aktuelt

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • MRI defined brain infarction or hemorrhage before or at the age of 65 years
  • CPSP diagnostic criteria is met (definite), verified by a neurologist
  • Stable analgesic medication
  • Average pain NRS 4 or more

Exclusion Criteria:

  • Epilepsy
  • Difficult aphasia
  • Dementia
  • Contraindication for TMS or MRI
  • Alcohol and/or drug abuse

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Transcranial Magnetic Stimulation I
Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex
Enhet: navigated rTMS of motor cortex
Navigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks.
Andre navn:
  • rTMS
  • Navigated
Eksperimentell: Transcranial Magnetic Stimulation II
Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the secondary somatosensory cortex
Enhet: navigated rTMS of somatosensory cortex 2
Navigated repetitive transcranial magnetic stimulation of the secondary somatosensory cortex ( 10 Hz ), 5 daily sessions per week for two weeks
Andre navn:
  • rTMS
  • Navigated
Sham-komparator: Sham Stimulation
Intervention: Repetitive sham Transcranial Magnetic Stimulation with SHAM block of the motor cortex
Enhet: SHAM rTMS with SHAM block
Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks.
Andre navn:
  • Placebo
  • rTMS
  • Navigated

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in average pain compared to baseline
Tidsramme: 1 month after each arm of the study
Patients will keep a pain diary for one week before stimulation and for two weeks after the stimulation. A nurse will call the patient one month after the last stimulation.
1 month after each arm of the study

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of life (EQ-5D)
Tidsramme: One week after each arm of the study and 6 months after the last one
Questionnaire EQ-5D
One week after each arm of the study and 6 months after the last one
Depression
Tidsramme: One week after each arm of the study and 6 months after the last stimulation
Questionnaire
One week after each arm of the study and 6 months after the last stimulation
Change in average pain compared to baseline
Tidsramme: 2,3,4,5 and 6 months after the last stimulation
Phone call ( Numeric Rating Scale (NRS) in rest and movement )
2,3,4,5 and 6 months after the last stimulation
Magnetoencephalography (MEG)
Tidsramme: One week before and after each arms stimulations
Changes in the irritability of the motor cortex and somatosensory cortex
One week before and after each arms stimulations
Number of patients with adverse effects
Tidsramme: From the start to the end of the study, on average 12 months per patient.
Adverse effects are followed actively
From the start to the end of the study, on average 12 months per patient.
Hands´ motor function and dexterity
Tidsramme: One week before and after each arm of the study
Nine hole peg, Pinch and Jamar
One week before and after each arm of the study
Cold water test
Tidsramme: One week before and after each arm of the study
Conditioned pain modulation (CPM)
One week before and after each arm of the study
Genetics
Tidsramme: No time frame, just a blood sample
Evaluation of genetical properties in terms of TMS related pain reduction
No time frame, just a blood sample

Samarbeidspartnere og etterforskere

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

Sponsor

Helsinki University Central Hospital

Etterforskere

  • Hovedetterforsker: Eija Kalso, PhD, Prof., Professor of Pain Research and Management, University of Helsinki. Director of the Multidisciplinary Pain Clinic, Department of Anaesthesia and Intensive Care Medicine Helsinki University Central Hospital
  • Studiestol: Jyrki Mäkelä, MD, PhD, Head of laboratory, BioMag, Helsinki University Central Hospital
  • Studiestol: Erika Kirveskari, MD, PhD, Head and Chief Physician of Clinical Neurophysiology at Medical Imaging Center, Helsinki University Hospital

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. mai 2013

Primær fullføring (Faktiske)

1. mai 2016

Studiet fullført (Faktiske)

1. september 2016

Datoer for studieregistrering

Først innsendt

22. oktober 2014

Først innsendt som oppfylte QC-kriteriene

27. oktober 2014

Først lagt ut (Anslag)

29. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. oktober 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. oktober 2018

Sist bekreftet

1. oktober 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TYH2013311

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

That is not allowed according to the ethical committees decision.

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. .

Kliniske studier på Sentral post-slagsmerte

Kliniske studier på navigated rTMS of motor cortex

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Portugal

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere