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- Klinische proef NCT01990313
Neural Signatures of Parkinson's Disease (BrainRadio)
22 januari 2018 bijgewerkt door: Helen M. Bronte-Stewart, Stanford University
Neural Signatures of Tremor, Bradykinesia and Freezing in the Subthalamic Region on Parkinson's Disease and Their Acute and Long-Term Modulation by Subthalamic Deep Brain Stimulation.
The purpose of this study is to provide objective measurements of abnormal movements of the body in correlation with neural activity of the brain and track how these change over time.
This may allow for the development of objective evaluation of the neural activity causing abnormal movements, which may lead to the ability of the DBS system to stimulate the brain by sensing the abnormal neural activity that is causing abnormal movements.
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Werkelijk)
15
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Stanford, California, Verenigde Staten, 94305
- Stanford University Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- a diagnosis of idiopathic Parkinson's disease, with bilateral symptoms at Hoehn and Yahr Stage greater than or equal to II.
- Documented improvement in motor signs on versus off dopaminergic medication, with a change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of >= 30% off to on medication.
- The presence of complications of medication such as wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication due to these factors.
- Subjects should be on stable doses of medications, which should remain unchanged until the DBS system is activated. After the DBS system is optimized (during which time the overall medication dose may be reduced to avoid discomfort and complications such as dyskinesias) the medication dose should remain unchanged, if possible, for the duration of the study.
- Treatment with carbidopa/levodopa, and with a dopamine agonist at the maximal tolerated doses as determined by a movement disorders neurologist.
- Ability and willingness to return for study visits, at the initial programming and after three, six and twelve months of DBS.
- Age > 18
Exclusion Criteria:
- Subjects with significant cognitive impairment and/or dementia as determined by a standardized neuropsychological battery.
- Subjects with clinically active depression, defined according to the Diagnostic and Statistical manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and as scored on a validated depression assessment scale.
- Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage 5 on medication (non-ambulatory).
- Age > 80.
- Subjects with an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump.
- Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding.
- Patients with cortical atrophy out of proportion to age or focal brain lesions that could indicate a non-idiopathic movement disorder as determined by MRI
- Subjects having a major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin).
- Subjects having any prior intracranial surgery.
- Subjects with a history of seizures.
- Subjects, who are immunocompromised.
- Subjects with an active infection.
- Subjects, who require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition.
- Subjects, who have an inability to comply with study follow-up visits.
- Subjects, who are unable to understand or sign the informed consent
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Activa PC+S
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The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Resting State Beta Band Power Over Time
Tijdsspanne: Baseline and 1 Year
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We compared the beta band (13-30 Hz) power in the neural signal at the initial programming visit (baseline) and at the 12 month follow-up visit (1 year) after turning off deep brain stimulation therapy.
Beta band power is normalized to average beta band power at the initial programming visit.
Using a linear mixed model for repeated measures over time, regression beta coefficient was obtained to determine if beta power changed significantly between the initial programming and the 12 month follow-up visit.
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Baseline and 1 Year
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Sample Beta Entropy
Tijdsspanne: 1 day
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Sample entropy is a measure of estimated conditional predictability, calculated within a frequency range of a patient's local field potential.
Freezers are subjects who have clinical history of freezing of gait symptoms and/or if the subject displayed freezing behavior pre-operatively or during the in-study gait tasks relative to non-freezers, those who have never experienced freezing of gait.
We measured sample beta (13-30 Hz) entropy in subjects' local field potential.
Higher values of sample entropy indicate lower estimated conditional predictability.
Testing occurred over one day, at a range of approximately 1 month to 7 months post DBS device implantation.
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1 day
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Helen Bronte-Stewart, MD,MSE,FAAN, Stanford University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Quinn EJ, Blumenfeld Z, Velisar A, Koop MM, Shreve LA, Trager MH, Hill BC, Kilbane C, Henderson JM, Bronte-Stewart H. Beta oscillations in freely moving Parkinson's subjects are attenuated during deep brain stimulation. Mov Disord. 2015 Nov;30(13):1750-8. doi: 10.1002/mds.26376. Epub 2015 Sep 11.
- Blumenfeld Z, Koop MM, Prieto TE, Shreve LA, Velisar A, Quinn EJ, Trager MH, Bronte-Stewart H. Sixty-hertz stimulation improves bradykinesia and amplifies subthalamic low-frequency oscillations. Mov Disord. 2017 Jan;32(1):80-88. doi: 10.1002/mds.26837. Epub 2016 Nov 8.
- Syrkin-Nikolau J, Koop MM, Prieto T, Anidi C, Afzal MF, Velisar A, Blumenfeld Z, Martin T, Trager M, Bronte-Stewart H. Subthalamic neural entropy is a feature of freezing of gait in freely moving people with Parkinson's disease. Neurobiol Dis. 2017 Dec;108:288-297. doi: 10.1016/j.nbd.2017.09.002. Epub 2017 Sep 7.
- Trager MH, Koop MM, Velisar A, Blumenfeld Z, Nikolau JS, Quinn EJ, Martin T, Bronte-Stewart H. Subthalamic beta oscillations are attenuated after withdrawal of chronic high frequency neurostimulation in Parkinson's disease. Neurobiol Dis. 2016 Dec;96:22-30. doi: 10.1016/j.nbd.2016.08.003. Epub 2016 Aug 21.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2013
Primaire voltooiing (Werkelijk)
1 november 2016
Studie voltooiing (Werkelijk)
1 november 2016
Studieregistratiedata
Eerst ingediend
6 november 2013
Eerst ingediend dat voldeed aan de QC-criteria
15 november 2013
Eerst geplaatst (Schatting)
21 november 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 februari 2018
Laatste update ingediend die voldeed aan QC-criteria
22 januari 2018
Laatst geverifieerd
1 januari 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 25916
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .