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

22. oktober 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Transcranial Magnetic Stimulation I
Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex
Enhed: 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 navne:
  • rTMS
  • Navigated
Eksperimentel: Transcranial Magnetic Stimulation II
Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the secondary somatosensory cortex
Enhed: 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 navne:
  • rTMS
  • Navigated
Sham-komparator: Sham Stimulation
Intervention: Repetitive sham Transcranial Magnetic Stimulation with SHAM block of the motor cortex
Enhed: SHAM rTMS with SHAM block
Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks.
Andre navne:
  • Placebo
  • rTMS
  • Navigated

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Helsinki University Central Hospital

Efterforskere

  • Ledende efterforsker: 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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2013

Primær færdiggørelse (Faktiske)

1. maj 2016

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

22. oktober 2014

Først indsendt, der opfyldte QC-kriterier

27. oktober 2014

Først opslået (Skøn)

29. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TYH2013311

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

That is not allowed according to the ethical committees decision.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Central post slagtilfælde smerte

Kliniske forsøg med navigated rTMS of motor cortex

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Betingelser

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