Repetitive Transcranial Magnetic Stimulation With H-coil in Parkinson's Disease (rTMS-PD) (rTMS-PD)
16. November 2020 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Interventionell
Einschreibung (Tatsächlich)
60
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
MI
-
Milan, MI, Italien, 20132
- IRCCS San Raffaele
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
Nicht älter als 80 Jahre (Kind, Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Real rTMS stimulation over M1 and PFC
|
Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
Real repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC
Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
|
|
Aktiver Komparator: Real rTMS stimulation over M1 and sham rTMS over PFC
|
Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
Real repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC
Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
|
|
Schein-Komparator: Sham rTMS over M1 and PFC
|
Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
Real repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC
Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change at Unified Parkinson's disease rating scale III over time
Zeitfenster: 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]
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change at Pegboard test over time
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Giancarlo Comi, MD, IRCCS San Raffaele
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
27. September 2010
Primärer Abschluss (Tatsächlich)
8. Juni 2012
Studienabschluss (Tatsächlich)
2. Juli 2012
Studienanmeldedaten
Zuerst eingereicht
5. November 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
16. November 2020
Zuerst gepostet (Tatsächlich)
20. November 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. November 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. November 2020
Zuletzt verifiziert
1. November 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- rTMS-PD
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
all IPD that underlie results in a publication
IPD-Sharing-Zeitrahmen
starting 6 months after publication
IPD-Sharing-Zugriffskriterien
data are available from the corresponding author, upon reasonable request
Art der unterstützenden IPD-Freigabeinformationen
- ICF
- ANALYTIC_CODE
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .