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Electrophysiology of Brain Activity During Electrode Implantation in Patients Treated With Deep Brain Stimulation (LFP-DBS)

12 de marzo de 2019 actualizado por: University Hospital, Grenoble

Primary objective

Demonstrate functional markers derived from electrophysiological signals recorded during cognitive tests. These markers should make it possible to optimize the targeting procedures of electrode implantation sites for a better effectiveness of deep brain stimulation therapy.

Research hypotheses

The mechanisms of action of the deep brain stimulation (DBS) involve the modulation of the activity, locally and on a large scale, of functional cortical-subcortical networks showing pathological behavior beforehand. The electrophysiological measurements in response to different tasks make it possible to highlight precise dysfunctions of these neural networks, in relation with the behavioral and / or motor disorders associated with the pathologies treated by DBS.

Consequently, we hypothesize that the exploitation of electrophysiological responses during cognitive or sensorimotor tasks performed during the implantation procedure of stimulation electrodes in patients treated with DBS will allow :

  • To collect fundamental data to understanding the physiological functioning of basal ganglia in humans ;
  • To collect functional markers from the operating room in relation to the symptoms targeted by the DBS that will help in the choice of implantation site of the stimulation electrode ;
  • Define long-term predictive markers of DBS effects by comparing electrophysiological effects measured post-operatively and clinical scores under DBS.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

125

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Grenoble, Francia
        • Reclutamiento
        • CHU Grenoble-Alpes
        • Contacto:
        • Contacto:
          • Stephan CHABARDES, Pr
          • Número de teléfono: 04 76 76 75 59

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Pathology requiring brain stimulation therapy (criteria of severity, therapeutic resistance and severity of disability): motor disorders (eg Parkinson's disease, dystonia) or psychiatric disorders (eg OCD, depression).
  • These pathologies therefore include motor disorders (eg Parkinson's disease, dystonia) or psychiatric disorders that can be treated with brain stimulation therapy. Note that these are independent of motor disorders. The inclusion criteria obviously depend on the pathology.

As an example for a motor pathology treated by stimulation, in Parkinson's disease the following inclusion criteria are used :

  • patients aged 18 to 75 and affiliated to a social security scheme
  • Idiopathic Parkinson's disease that meets the United Kingdom Parkinson's Disease Brain Bank (UKPDSBB) criteria or suffering from recessive autosomal juvenile parkinsonism
  • duration of evolution of the disease> 5 years
  • stage of severe motor complications of levodopa despite optimal treatment.

For dystonic patients, the following inclusion criteria are used :

  • Disabling dystonia (severe focal, segmental or generalized).
  • Patient ≥ 18 years of age and under age 65
  • Duration of evolution of dystonia greater than one year.

For patients with obsessive-compulsive disorder (OCD), the following inclusion criteria are used :

  • OCD which has been diagnosed for at least 5 years according to the DSM-IV criteria as OCD with "good insight", confirmed using the Diagnostic Interview Genetic Study (DIGS) - OCD section ; score below the delusional idea threshold at the BABS (Brown Assessment of Beliefs Scale) insight scale (Eisen, Phillips et al., 1998)
  • OCD of severe intensity (total YBOCS > 25, or subscale Obsessions or Compulsions > 15, EGF < 40, CGI > 4) with prognosis considered to be bad in the absence of intervention
  • Non-responder OCD (an improvement of less than 25% on the Y-BOCS scale) to at least three IRS-type antidepressants, including clomipramine, used sequentially at the maximum tolerated dose for at least 12 weeks. Used alone and in combination for at least 1 month with risperidone or pimozide and any of the following products : lithium salts or clonazepam or buspirone or pindolol (Greist and Jefferson 1998) (McDougle, Epperson et al 2000) (Dannon , Sasson et al., 2000)
  • OCD having benefited from Behavioral and Cognitive Therapy for at least 1 year (application of classical programs, including exposure techniques with prevention of ritualized response, with at least two sessions per month).
  • Patient between 18 and 60 years of age who has given his signature and informed consent after receiving written information on the proposed procedure
  • Sick with social security

For patients with depressive illness, the following inclusion criteria were used :

  • male or female between the ages of 30 and 65
  • with a diagnosis of unipolar major depression (MINI) resistant to conventional treatments
  • Hamilton and Montgomery Depression Scale (HAMD) score> 20
  • Duration of the current depressive episode of more than 12 months, the patient being included in a care system has established the chronic and recurrent state of this depression,
  • Ineffective treatment of the current episode with at least 4 therapeutic attempts including antidepressant drug monotherapy treatments (MAOIs, tricyclic antidepressants, selective serotonin reuptake inhibitors, mixed serotonin reuptake inhibitors, and norepinephrine), the potentiations of antidepressant treatments (by lithium salts, thyroid hormones or neuroleptics), the psychotherapies structured according to validated techniques, the ECT carried out under conditions in conformity with the recommendations (ANAES, 1998) (at least 6 sessions in technical bilateral with control of duration of seizure)

    • Women of childbearing age should follow a contraceptive method that is considered sufficiently effective by the investigator. In this case a pregnancy test will be performed on inclusion
    • outpatient or inpatient
    • fluent in the French language and able to understand the procedures of the study and in particular complete the self-questionnaires used
    • Patient likely to give informed consent
    • Patient affiliated with Social Security
    • Patient's written agreement to participate in the study
    • Intellectual abilities compatible with cognitive or motor tasks

Exclusion Criteria:

  • Persons referred to in Articles L1121-5 to L1121-8 of the CSP.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: electrophysiological data from DBS
For each selected patient, the evaluation of cognitive or sensory-motor functions by electrophysiology will be conducted in the operating room, preoperatively the week before implantation and post-operatively within five days between the implantation of deep electrodes and the setting of the stimulator.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of functional markers derived from electrophysiological signals recorded during cognitive tests.
Periodo de tiempo: 5 days
The latency of task-related electrophysiological responses derived from deep brain electrodes, as assessed by time-frequency and evoked-responses analyses.
5 days
Number of functional markers derived from electrophysiological signals recorded during cognitive tests.
Periodo de tiempo: 5 days
The amplitude of task-related electrophysiological responses derived from deep brain electrodes, as assessed by time-frequency and evoked-responses analyses.
5 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
cognitive and sensorimotor tasks
Periodo de tiempo: 5 days
percentage of electrode contacts within a given brain area that will display task-evoked neural responses (as assessed by time-frequency analyses) for a given task.
5 days
functional atlas of basal ganglia
Periodo de tiempo: 5 days
statistical effects of each task as assessed by t-tests performed across patient's task-related electrophysiological responses (as assessed by time-frequency analyses).
5 days
number of electrophysiological responses
Periodo de tiempo: 5 days
time and frequency analyses
5 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de abril de 2011

Finalización primaria (Anticipado)

31 de marzo de 2021

Finalización del estudio (Anticipado)

31 de marzo de 2021

Fechas de registro del estudio

Enviado por primera vez

30 de abril de 2018

Primero enviado que cumplió con los criterios de control de calidad

12 de marzo de 2019

Publicado por primera vez (Actual)

14 de marzo de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de marzo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

12 de marzo de 2019

Última verificación

1 de junio de 2018

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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