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Repetitive Transcranial Magnetic Stimulation With H-coil in Parkinson's Disease (rTMS-PD) (rTMS-PD)

16. november 2020 opdateret af: Giancarlo Comi

Repetitive Transcranial Magnetic Stimulation With H-coil in Parkinson's Disease: A Double-blind, Placebo-controlled Study

Focal repetitive transcranial magnetic stimulation (rTMS) has been applied to improve symptoms in Parkinson disease (PD) with conflicting results. However, the stimulation with H-coil has been shown to stimulate a wider cortical area compared with the standard coils, with preliminary results confirming the potential efficacy of the treatment. In this study the investigators aimed to explore the safety and efficacy of excitatory rTMS with H-coil on PD motor symptoms.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This was a double-blind, placebo-controlled study, with a 1:1:1 randomization into three groups: group 1 - real rTMS over primary motor cortex and prefrontal cortex (M1-PFC): group 2 - real rTMS over M1 and sham rTMS over PFC; group 3 - sham stimulation over both targets

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Italien
    • MI
      • Milan, MI, Italien, 20132
        • IRCCS San Raffaele

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

Ikke ældre end 80 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female subjects aged ≤80 years
  • Diagnosis of Parkinson's disease according to UK Brain Bank criteria
  • Hoehn and Yahr (HY) scale II-IV
  • Stable anti-depressive and anti-parkinsonian therapy for at least two months prior to enrollment
  • Subjects who answered all questions in the TMS pre-treatment safety questionnaire in a negative manner.
  • Have given written informed consent

Exclusion Criteria:

  • Presence of an additional neurological or psychiatric pathology
  • Severe personality disorder
  • Uncontrolled hypertension.
  • History of epilepsy, seizures, febrile convulsions.
  • History of epilepsy or seizures in first degree relatives.
  • History of head injury or stroke.
  • Presence of metal prostheses in the head (except dental fillings).
  • Metal implants or known history of any metal particles in the eye, cardiac pacemakers, cochlear implants, use of neurostimulators or medical pumps.
  • History of migraine within the past six months.
  • History of drug or alcohol abuse.
  • Impossibility of adequate communication with the examiner.
  • Participation in another clinical study, either concomitant or within the previous 3 months.
  • Inability to sign the consent form.

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: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Real rTMS stimulation over M1 and PFC
Enhed: rTMS with H-coil
Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
Enhed: rTMS with H-coil
Real repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC
Enhed: rTMS with H-coil
Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
Aktiv komparator: Real rTMS stimulation over M1 and sham rTMS over PFC
Enhed: rTMS with H-coil
Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
Enhed: rTMS with H-coil
Real repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC
Enhed: rTMS with H-coil
Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
Sham-komparator: Sham rTMS over M1 and PFC
Enhed: rTMS with H-coil
Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
Enhed: rTMS with H-coil
Real repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC
Enhed: rTMS with H-coil
Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change at Unified Parkinson's disease rating scale III over time
Tidsramme: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
A comprehensive 50 question assessment of both motor and non-motor symptoms associated with Parkinson's
Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Incidence of Treatment-Emergent adverse events [Safety and Tolerability of rTMS]
Tidsramme: End of treatment (1 month after start of the treatment)
monitoring presence of side effects due to the stimulation
End of treatment (1 month after start of the treatment)

Sekundære resultatmål

Resultatmål
Tidsramme
Change at Pegboard test over time
Tidsramme: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Tapping test over time
Tidsramme: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Up & Go Test over time
Tidsramme: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at dyskinesia rating scale over time
Tidsramme: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at and at Word Fluency test over time
Tidsramme: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Digit forward & backward test over time
Tidsramme: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Beck Depression Inventory scale-II over time
Tidsramme: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at The Clinical Global Impression - Severity scale ( CGI-S) over time
Tidsramme: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)

Samarbejdspartnere og efterforskere

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

Sponsor

Giancarlo Comi

Efterforskere

  • Ledende efterforsker: Giancarlo Comi, MD, IRCCS San Raffaele

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)

27. september 2010

Primær færdiggørelse (Faktiske)

8. juni 2012

Studieafslutning (Faktiske)

2. juli 2012

Datoer for studieregistrering

Først indsendt

5. november 2020

Først indsendt, der opfyldte QC-kriterier

16. november 2020

Først opslået (Faktiske)

20. november 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • rTMS-PD

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

all IPD that underlie results in a publication

IPD-delingstidsramme

starting 6 months after publication

IPD-delingsadgangskriterier

data are available from the corresponding author, upon reasonable request

IPD-deling Understøttende informationstype

  • ICF
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Parkinsons sygdom

Kliniske forsøg med rTMS with H-coil

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