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Eine Studie entspricht den Filterkriterien
Kartenansicht
Identifying the Neural Signature of Exercise to Advance Treatment of PD Cognitive Declines
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05972759 ist eine interventionsstudie zur Untersuchung von Parkinson-Krankheit und hat den Status offene rekrutierung. Die Studie startete am 15. August 2023 und soll 25 Teilnehmer aufnehmen. Durchgeführt von The Cleveland Clinic ist der Abschluss für 31. Dezember 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 24. Juli 2025 aktualisiert.
Kurzbeschreibung
Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be enrolled for this project and complete a single bout of both FE and VE. The 150-minute experimental session will be completed in the OFF antiparkinsonian and Off-DBS state.
Ausführliche Beschreibung
Parkinson's disease (PD) is a progressive neurological disease, most prevalent in older adults, estimated to affect over 12 million people world-wide by 2040. Traditionally considered a motor disorder, the impact of PD on cognitive performance is now widely accepted with 80% of PD patients developing executive function impairments. Typical PD related cognitive effects include impaired information processing, set-switching, working memory and dual-tasking. While antiparkinsonian medication and deep brain simulation (DBS) are effective in managing disease symptoms, disease modification has remained elusive. Exercise has been proposed as the Universal Prescription for PD capable of slowing disease progression; stationary cycling in particular has been suggested as an ideal exercise modality for people with PD (PwPD). The investigator's seminal tandem cycling study was the first to utilize forced exercise (FE) in human PD patients and demonstrated a 30% improvement in clinical ratings compared to voluntary exercise (VE). Briefly, FE is a mode of high intensity exercise originating in animal models of PD in which voluntary exercise rate is augmented, but not replaced. Thus, PwPD were assisted in pedaling at a higher rate (cadence) on the tandem cycle compared to those on a standard stationary cycle performing voluntary exercise (VE). This work resulted in a paradigm shift in terms of recommending high intensity exercise for PwPD. Despite the potential of exercise to alter disease progression, its mechanism of action and effects on basal ganglia function are not understood.
Offizieller Titel
Identifying the Neural Signature of Exercise to Advance Treatment of PD Cognitive Declines
Erkrankungen
Parkinson-KrankheitPublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:Weitere Studien-IDs
- 22-568
NCT-Nummer
Studienbeginn (tatsächlich)
2023-08-15
Zuletzt aktualisiert
2025-07-24
Studienende (vorauss.)
2025-12-31
Geplante Rekrutierung
25
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Deep Brain Stimulation
DBS
DBS
Primäres Ziel
Grundlagenforschung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellExperimental Arm Two modes of high intensity exercise. | Forced and Voluntary Exercise Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be enrolled for this project and complete a single bout of both FE and VE. The 150-minute experimental session will be completed in the OFF antiparkinsonian and Off-DBS state. |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Local Field Potentials during Cognitive Testing | Change in power in frequency bands of interest | an average of 3 total days |
Trail Making Test A & B | Change in neuropsychological tests designed to evaluate set-switching and attention | an average of 3 total days |
Information Processing | Change in mobile application of simple and choice reaction time | an average of 3 total days |
N-Back Test | Change in working memory test of word recall | an average of 3 total days |
Force-tracking with n-back | Change in upper extremity motor control assessment with cognitive component | an average of 3 total days |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Adult with a diagnosis of PD by a movement disorders neurologist
- Previous placement, at least six months, of bilateral Medtronic Precept DBS as standard of care treatment for their PD.
- Stable and clinically optimized DBS parameters for three months prior to enrollment.
- Demonstrate the ability to safely mount and dismount a recumbent exercise cycle with an upright back.
- Willingness to withhold antiparkinsonian medication and DBS stimulation.
- Exercise clearance using the American College of Sports Medicine (ACSM) Pre-participation Health Screen: a. If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provider prior to participation; b. Those who choose not to obtain physician clearance will not be eligible for participation.
- Diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent.
- A musculoskeletal issue that limits one's ability to cycle
- Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke) that impacts motor or cognitive function
- Uncontrolled cardiovascular risk factor such as a current cardiac arrhythmia, uncontrolled hypertension, untreated deep vein thrombosis, etc.
Verantwortliche Partei
Jay Alberts, Hauptprüfer, Principal Investigator, The Cleveland Clinic
Zentrale Studienkontakte
Kontakt: MacKenzie Dunlap, BS, 216-219-3949, [email protected]
Kontakt: Elizabeth Jansen, MPH, 216-445-3866, [email protected]
1 Studienstandorte in 1 Ländern
Ohio
Cleveland Clinic, Cleveland, Ohio, 44195, United States
MacKenzie Dunlap, Kontakt, 216-219-3949, [email protected]
Jay Alberts, Ph.D., Hauptprüfer
Offene Rekrutierung