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Inhibitory rTMS in Dystonic Wilson Patients (WILSTIM)

14. juni 2021 opdateret af: Assistance Publique - Hôpitaux de Paris

Study of Writing Improvement in Patients With Wilson Disease and Dystonia After One Session of Inhibitory Repetitive Transcranial Magnetic Stimulation

Wilson disease is a genetic disorder resulting in copper accumulation in liver, brain and eye. The neurologic complications include dystonic syndrome, which is a prolonged and excessive muscle activation responsible for abnormal postures. Hand dystonia prevents daily life activities such as writing, which is particularly disabling, since writing is the only mean of communication in these patients with significant slurred speech. Treatment is limited and only partially effective.

Low frequency (<or=1Hz) repetitive transcranial magnetic stimulation (rTMS) has shown inhibiting properties when applied over the cortex. Since dystonia has been correlated to hyperactivation of the neurons of the somatosensory cortex (SSC), we hypothesize that one single 20-minute session of 1 Hz rTMS applied on left SSC will improve writing of the right dystonic hand, assessed immediately at the end of the session.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study investigates the handwriting performance of an homogeneous cohort of patients with Wilson disease and right handed dystonia, after one single inhibitory repetitive transcranial magnetic stimulation (rTMS). Fifteen patients with focal right hand dystonia will receive randomly either active or sham rTMS (1 Hz) to the left somatosensory cortex (SSC) in one single 20 minutes session. Handwriting performance will be measured immediately after this unique session (Visual analogic scale of subjective discomfort in writing, DPRE and WCRS scales, pen pressure and pen velocity measured on touchpad), compared to scores obtained 24 hours before the session. Three days later, the patient will receive the other session (sham rTMS or active rTMS) and the same parameters will be evaluated.

This is a single-center, randomized, crossover, prospective, clinical and double-blind study (the rTMS session is performed by the neurophysiologist, but the patient and the neurologist who will perform the handwriting evaluation are blind to the session).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

14

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
    • Ile De France
      • Paris, Ile De France, Frankrig, 75010
        • Hospital Lariboisière

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:

  • Wilson disease with focal right hand dystonia
  • No modification of medical treatment for 6 months
  • No botulinum toxin administration within the past four months
  • Right handed
  • Focal right hand dystonia
  • Cerebral Magnetic Resonance performed the last 6 months with no other lesion than met in Wilson disease
  • Over 18
  • Insurance policy holder
  • Informed consent

Exclusion Criteria:

  • Pregnant woman
  • Guardianship procedure
  • Seizure history
  • Other cerebral lesions on cerebral MRI than met in Wilson Disease
  • Unable to stay quiet for 30 minutes
  • Handwriting impossible
  • Contra-indications to repetitive Transcranial Magnetic Stimulation

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: Active rTMS
Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session.
Enhed: Repetitive Transcranial Magnetic Stimulation (rTMS)
Inhibitory 1 Hz rTMS, delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session.
Andet: pre and post-rTMS electroencephalogram
to verify the absence of infraclinical seizures
Andet: WCRS
Writer's cramp rating scale
Andet: handwriting scale DPRE
handwriting in development and being evaluated by the NRC Wilson
Andet: visual analog scale of discomfort writing and parameters collected on touchpad
Sham-komparator: Sham rTMS
Placebo Transcranial Magnetic stimulation delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session.
Enhed: Repetitive Transcranial Magnetic Stimulation (rTMS)
Inhibitory 1 Hz rTMS, delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session.
Andet: pre and post-rTMS electroencephalogram
to verify the absence of infraclinical seizures
Andet: WCRS
Writer's cramp rating scale
Andet: handwriting scale DPRE
handwriting in development and being evaluated by the NRC Wilson
Andet: visual analog scale of discomfort writing and parameters collected on touchpad

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
immediate and significant improvement in writing
Tidsramme: up to 1 week

Improvement of handwriting performance immediately after one single 20 minutes session of inhibitory (1 Hz) repetitive transcranial magnetic stimulation over the left somatosensory cortex.

quantitative test score of writing WCRS

Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later.
up to 1 week

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
significant improvement in writing
Tidsramme: up to 1 week

improvement of other quantitative test scores of writing (VAS subjective discomfort writing, DPRE scales and parameters measured on touchpad) after a single session of 1 Hz rTMS inhibitory to the left CSS , compared to the scores achieved in the 24 hours before the session of rTMS.

Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later.
up to 1 week
improvement of dystonia on the scale WDRS
Tidsramme: up to 1 week

Assessing the improvement of dystonia on the scale WDRS after a single session of 1 Hz rTMS inhibitory to the left CSS, compared to the scores achieved in the 24 hours before the session of rTMS.

Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later.
up to 1 week
correlation between the scores and the other parameters of disease severity
Tidsramme: up to 1 week
Assess whether age, disease duration and the presence of cortical atrophy are inversely correlated with the evolution of scores.
up to 1 week

Samarbejdspartnere og efterforskere

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Efterforskere

  • Studieleder: Nathalie KUBIS, MD, PhD, Physiology Department, Lariboisière Hospital
  • Ledende efterforsker: Jean-Marc TROCELLO, MD, Neurology, Lariboisière 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 (Faktiske)

1. januar 2014

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. juli 2015

Datoer for studieregistrering

Først indsendt

24. oktober 2013

Først indsendt, der opfyldte QC-kriterier

4. november 2013

Først opslået (Skøn)

11. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P121105

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 Bevægelsesforstyrrelser

Kliniske forsøg med Repetitive Transcranial Magnetic Stimulation (rTMS)

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