- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04255719
Unilateral GPi vs Unilateral STN DBS in the Same Patient With PD
Unilateral Pallidal vs Unilateral Subthalamic Nucleus Deep Brain Stimulation in the Same Patient With Parkinson Disease: A Randomized Controlled Trial
The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two main targets in the deep brain stimulation (DBS) treatment for Parkinson's disease (PD). Large randomized controlled trials, in which patients of comparable clinical and demographics were randomized to either GPi DBS or STN DBS, have demonstrated equal effects of both targets in motor symptom improvement, the superiority of STN DBS in the medication reduction and the potential advantage of GPi DBS for cognitive, psychiatric and axial aspects. Unfortunately, in such a highly heterogeneous disease of PD, many of these randomized controlled trials didn't include sufficient subjects and thereby yielded inconsistent results. Moreover, most studies are investigating the difference between GPi and STN in different patients.
In order to address the problem, an intra-patient comparison will be made by investigating the acute turning-on effects of unilateral STN stimulation versus unilateral GPi stimulation on axial symptoms, cognition and also cardinal symptoms within each individual patient who received the treatment of combined unilateral STN and contralateral GPi DBS. Axial symptoms including gait, balance and posture, motor symptoms and cognition are comprehensively assessed under two treatment conditions.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200025
- Functional neurosurgery of Shanghai Jiaotong University affiliated Ruijin Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with idiopathic Parkinson's disease
- Aged between 55 and 75 years, both male and female
- Patients who have undergone combined unilateral STN and contralateral GPi DBS for more than 6 months
- A Hoehn-Yahr (H-Y) stage of less than 4 in the off-medication state
- A left-extremity to right-extremity ratio of less than 0.15 on the Unified Parkinson's Disease Rating Scale part Ⅲ (UPDRS-Ⅲ) in the both off-medication and on-medication states
Exclusion Criteria:
- History of serious psychosis
- History of intractable epilepsy (i.e., seizures)
- Diagnosed by the investigators that patients with severe cardiac, liver and kidney diseases, or other serious health conditions
- Dementia (A Mini-Mental State Examination (MMSE) score of < 24), inability to comprehend the experimental protocol or voluntarily provide informed consent
- Lack of cooperation
- Additional reasons for exclusion at the discretion of the clinical investigator
- Poorly controlled depression or anxiety
- Past history of suicidal attempt
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Unilateral DBS of the subthalamic nucleus (STN)
To deliver unilateral STN DBS, bilateral stimulation will be turned off for three hours, and then turn on the unilateral STN DBS.
The STN stimulation will be programmed as previous parameter configuration with optimal therapeutic benefits.
Participants will be asked to complete a comprehensive set of assessments under unilateral STN stimulation in the off-medication state.
45 minutes after taking regular medication, participants need to complete the second set of assessments in the on-medication state.
|
Unilateral DBS for treatment of patients with PD
|
Eksperimentel: Unilateral DBS of the globus pallidus interna (GPi)
To deliver unilateral GPi DBS, bilateral stimulation will be turned off for three hours, and then turn on the unilateral GPi DBS.
The study protocol is identical to the intervention of unilateral STN DBS but it was done on a different day.
|
Unilateral DBS for treatment of patients with PD
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Difference in Timed Up-and-Go (TUG) task scores between treatment conditions in the on- and off- medication states
Tidsramme: 6 months
|
Timed Up-and-Go task is a well-defined objective gait measurement.
The task requires an individual to stand up, walk 5 m, turn, walk back, and sit down.
The time taken to complete the test is strongly correlated with the level of functional mobility.
This test will be videotaped and scored by two blinded neurologists.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Differences in total Unified Parkinson's Disease Rating Scale Part Ⅲ (UPDRS Ⅲ) scores between two treatment conditions in the on- and off- medication states
Tidsramme: 6 months
|
Unified Parkinson's Disease Rating Scale Part Ⅲ measures the motor severity of Parkinson's disease.
UPDRS Ⅲ score has a range of 0 (no symptoms) to 132 (severe disease symptoms).
|
6 months
|
Differences in Burg Balance Scale (BBS) scores between two treatment conditions in the on- and off- medication states.
Tidsramme: 6 months
|
Burg Balance Scale measures patients' static and dynamic balance abilities.
BBS score has a range of 0 (severe balance problems) to 56 (no balance problems).
|
6 months
|
Differences in postural angles between two treatment conditions in the on- and off- medication states.
Tidsramme: 6 months
|
The measurement of postural angles is the same as the paper (Yamada et al) published in J Neurol Neurosurg Psychiatry
|
6 months
|
Differences in Water Swallow Test (WST) scores between treatment conditions in the on- and off- medication states.
Tidsramme: 6 months
|
The Water Swallow Test is frequently used in clinical practice as a functional assessment to detect dysphagia, with stage 1 indicating severe dysphagia and stage 6 indicating normal swallowing function.
|
6 months
|
Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.
Tidsramme: 6 months
|
The Swallowing Disturbance Questionnaire is created as a self-rated dysphagia screening tool in PD, with a range of 0 (normal swallowing function) to 42 (severe dysphagia).
|
6 months
|
Differences in voice parameters between treatment conditions in the on- and off- medication states.
Tidsramme: 6 months
|
Voice recording at a sampling rate of 44.1 kHz using 16-bit quantification will be conducted in a sound-treated room using a microphone and a digital voice recorder with a mouth-to-microphone distance of 15 cm.
The recorded voices will then be used for a composit acoustic analysis.
|
6 months
|
Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states.
Tidsramme: 6 months
|
The Voice Handicap Index is a self-administered instrument, comprising 30 items on voice-related dysfunction.
VHI has a range of 0 (normal voice function) to 120 (severe voice dysfunction).
|
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Lizarraga KJ, Luca CC, De Salles A, Gorgulho A, Lang AE, Fasano A. Asymmetric neuromodulation of motor circuits in Parkinson's disease: The role of subthalamic deep brain stimulation. Surg Neurol Int. 2017 Oct 24;8:261. doi: 10.4103/sni.sni_292_17. eCollection 2017.
- Yamada K, Shinojima N, Hamasaki T, Kuratsu J. Subthalamic nucleus stimulation improves Parkinson's disease-associated camptocormia in parallel to its preoperative levodopa responsiveness. J Neurol Neurosurg Psychiatry. 2016 Jul;87(7):703-9. doi: 10.1136/jnnp-2015-310926. Epub 2015 Sep 30.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2020 UPS study
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 Parkinsons sygdom
-
Abbott Medical DevicesBaylor College of Medicine; University of HoustonAfsluttet
-
Bial - Portela C S.A.Afsluttet
-
Mayo ClinicAfsluttet
-
Ataturk UniversityRekruttering
-
Centre Hospitalier Universitaire, AmiensUkendtParkinson | ImpulskontrolforstyrrelseFrankrig
-
Institute for Neurodegenerative DisordersAfsluttetParkinson | Parkinsons syndromForenede Stater
-
Assistance Publique - Hôpitaux de ParisCentre Hospitalier Universitaire de Pointe-a-PitreAfsluttet
-
University of MinnesotaTrukket tilbageParkinsons sygdom | ParkinsonForenede Stater
-
National Taiwan University HospitalAfsluttet
-
University of PlymouthIkke rekrutterer endnuParkinsons sygdom | ParkinsonDet Forenede Kongerige
Kliniske forsøg med DBS
-
Deep Brain Innovations LLCAfsluttetParkinsons sygdomForenede Stater
-
Chinese PLA General HospitalIkke rekrutterer endnuCervikal dystoniKina
-
University Medical Center GroningenUkendt
-
Jaimie M. HendersonHarvard Medical School (HMS and HSDM); The Cleveland Clinic; Weill Medical... og andre samarbejdspartnereAfsluttetTBI (traumatisk hjerneskade)Forenede Stater
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Radboud University Medical Center; University Medical Center Groningen; Maastricht... og andre samarbejdspartnereRekrutteringSygdomme i centralnervesystemet | Essential Tremor | Dyb hjernestimulation | Magnetisk resonans | Diffusion Tensor ImagingHolland
-
University of TorontoIkke rekrutterer endnu
-
University of Southern CaliforniaAfsluttetParkinsons sygdomForenede Stater
-
Functional Neuromodulation LtdAktiv, ikke rekrutterendeAlzheimers sygdomForenede Stater, Canada, Tyskland
-
Ruijin HospitalNational Natural Science Foundation of China; Icahn School of Medicine... og andre samarbejdspartnereTrukket tilbage
-
University of British ColumbiaIkke rekrutterer endnu