State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS)

State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS

Patrocinadores

Patrocinador principal: University of Minnesota

Fuente University of Minnesota
Resumen breve

The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in Parkinson's disease and how they relate to DBS and pharmacological management, not to bring new devices to market.

Descripción detallada

Experimental: chronic brain recording This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.

Estado general Active, not recruiting
Fecha de inicio July 20, 2017
Fecha de Terminación July 31, 2020
Fecha de finalización primaria July 31, 2019
Fase Phase 1
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Cortical and sub-cortical brain signals using Activa PC+S 12 months
Inscripción 4
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Activa PC+S

Descripción: DBS

Etiqueta de grupo de brazo: chronic brain recording

Elegibilidad

Criterios:

Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's Disease (PD).

2. Age 45-75 years

3. UPDRS III motor score (off PD medications) ≥ 25

4. Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)

5. Approved for unilateral subthalamic nucleus (STN)- or globus pallidus internus (GPi)-DBS surgery to treat their clinical motor signs and plan to undergo the standard of care procedure within the next four months

6. Cleared to be scanned in a 7 tesla magnet

7. Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process

Exclusion Criteria:

1. Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., significant cardiac or pulmonary disease)

2. Evidence of secondary or atypical parkinsonism

3. Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.

4. Unable to undergo magnetic resonance imaging (e.g., due to incompatible implanted pacemaker)

5. Previous pallidotomy or DBS surgery

6. Women who are currently pregnant or are breast feeding

7. MRI showing cortical atrophy out of proportion to age and/or MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder

8. Any prior intracranial surgery

9. Subjects with depression defined according to Diagnostic and Statistical Manual V criteria and a scored on a validated depression assessment scale

10. History of seizures

11. Immunocompromised

12. Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition

13. Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.

Género: All

Edad mínima: 45 Years

Edad máxima: 75 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Jerrold Vitek, MD, PhD Principal Investigator University of Minnesota
Ubicación
Instalaciones: University of Minnesota
Ubicacion Paises

United States

Fecha de verificación

October 2019

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: chronic brain recording

Tipo: Experimental

Descripción: This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.

Datos del paciente Undecided
Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Basic Science

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov