- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02235792
High Frequency Oscillations in Neurologic Disease
Chronically-recorded Deep Brain Nuclei/Hippocampal High Frequency Oscillations (HFOs) as Biomarkers of Neurologic Disease.
Panoramica dello studio
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic in Rochester
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion criteria:
Medically-refractory neurologic disease amenable to therapy with deep brain stimulation including:
Idiopathic Parkinson disease with motor fluctuation, dyskinesia, and/or medically refractory tremor despite optimal medical management by a movement disorders neurologist.
OR
Unilateral or bilateral mesial temporal lobe (hippocampal) epilepsy with complex partial, and/or secondarily generalized seizures, that is:
- confirmed through a combination of interictal scalp EEG, ictal scalp EEG under video monitoring, ictal SPECT scanning, and/or invasive EEG monitoring
- disabling seizure counts >2 per month documented over a 3 month period
- refractory to at least three antiepileptic drugs given at clinically appropriate maintenance doses resulting in therapeutic plasma levels (in cases where such levels have been established for that particular drug. Drug failures because of side- effects will not be counted toward this total.
- determined to have mesial temporal lobe epilepsy that is not amenable to resective surgery according to consensus opinion among epileptologists on our institution's multidisciplinary Epilepsy Surgery Committee
- Mayo Clinic Deep Brain Stimulation Committee approval for bilateral deep brain stimulation therapy obtained on routine clinical grounds and without reference to this protocol.
- Age 18 to 75.
- Ability and willingness to provide informed consent and participate in the study protocol.
Exclusion criteria:
- Diagnoses other than those included in #1 above.
- Comorbid nonepileptic behavioral events or psychogenic movement disorder.
- Medical contraindications to DBS surgery.
- Psychiatric comorbidities not under stable medical therapy.
- Neurodegenerative dementia (cognitive dysfunction resulting from frequent seizure activity will not be an exclusion criteria).
- Implanted electronically active medical device with the potential to interfere with intracranial recordings (ex. pacemaker, automatic implantable cardioverter defibrillator (AICD), active vagal nerve stimulator).
- Pregnancy; women of child-bearing potential will be required to commit to using an effective method of contraception during the entire duration of the trial. If a subject becomes pregnant despite these precautions, she will be required to report that to our center within two weeks at which point explantation of the experimental device would be an option.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Deep Brain Stimulation 37604 Activa PC+S
All subjects will undergo DBS using the 37604 Activa PC+S device (single arm study).
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The model 37604 Activa PC+S system is a multiprogrammable device that both delivers electrical stimulation and records bioelectric data through one or two leads implanted in the brain.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Degree of correlation of recorded neural signatures with disease severity as determined by regression analysis
Lasso di tempo: 26 weeks post deep brain stimulator implantation
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Regression analysis will be performed using the measures of clinical disease severity as the independent variables and the various HFO measurement conditions/parameters as dependent variables. HFO parameters to be analyzed will include: 1) total power within each recorded band and 2) frequency distribution as defined by the ratio of power within the higher HFO frequency band versus the lower HFO frequency band. Clinical disease severity will be determined by: 1) Unified Parkinson's Disease Rating Scale (UPDRS III) score in each of the various conditions for Parkinson Disease (PD) subjects, 2) motor diaries linked with each visit for PD subjects, and 3) seizure counts from the 4 weeks of seizure diary preceding each visit for epilepsy subjects. (Note: UPDRS is a rating scale used to follow the longitudinal course of Parkinson's disease. Part III is a clinician-scored monitored motor evaluation.) |
26 weeks post deep brain stimulator implantation
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Bryan Klassen, MD, Mayo Clinic
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 13-002360
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Activa PC+S
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Vibhor KrishnaRitiratoMorbo di ParkinsonStati Uniti
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University of WashingtonCompletato
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University Health Network, TorontoMedtronicCompletatoMorbo di ParkinsonCanada
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University of California, San FranciscoMedtronicCompletatoMorbo di Parkinson | Distonia isolataStati Uniti
-
University of MinnesotaCompletato
-
Colorado Neurological InstituteMedtronic; Swedish Medical CenterSconosciuto
-
Jonathan JagidMedtronicCompletatoLesioni del midollo spinaleStati Uniti
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Simon J. Little, MBBS, PhDAttivo, non reclutanteMorbo di ParkinsonStati Uniti
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Stanford UniversityCompletatoMorbo di ParkinsonStati Uniti
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UMC UtrechtCompletatoSindrome da bloccoOlanda