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

16 november 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Faktisk)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 80 år (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Real rTMS stimulation over M1 and PFC
Enhet: rTMS with H-coil
Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
Enhet: 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
Enhet: 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
Enhet: rTMS with H-coil
Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
Enhet: 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
Enhet: rTMS with H-coil
Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
Sham Comparator: Sham rTMS over M1 and PFC
Enhet: rTMS with H-coil
Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
Enhet: 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
Enhet: rTMS with H-coil
Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change at Unified Parkinson's disease rating scale III over time
Tidsram: 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]
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Tidsram
Change at Pegboard test over time
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Giancarlo Comi

Utredare

  • Huvudutredare: Giancarlo Comi, MD, IRCCS San Raffaele

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

27 september 2010

Primärt slutförande (Faktisk)

8 juni 2012

Avslutad studie (Faktisk)

2 juli 2012

Studieregistreringsdatum

Först inskickad

5 november 2020

Först inskickad som uppfyllde QC-kriterierna

16 november 2020

Första postat (Faktisk)

20 november 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 november 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 november 2020

Senast verifierad

1 november 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • rTMS-PD

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

all IPD that underlie results in a publication

Tidsram för IPD-delning

starting 6 months after publication

Kriterier för IPD Sharing Access

data are available from the corresponding author, upon reasonable request

IPD-delning som stöder informationstyp

  • ICF
  • ANALYTIC_CODE

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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