Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Unilateral GPi vs Unilateral STN DBS in the Same Patient With PD

2 de marzo de 2021 actualizado por: Bomin Sun, Ruijin Hospital

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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

9

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.

Ubicaciones de estudio

    • Shanghai
      • Shanghai, Shanghai, Porcelana, 200025
        • Functional neurosurgery of Shanghai Jiaotong University affiliated Ruijin Hospital

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

55 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Experimental: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference in Timed Up-and-Go (TUG) task scores between treatment conditions in the on- and off- medication states
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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

Colaboradores e Investigadores

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

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el 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)

1 de marzo de 2020

Finalización primaria (Actual)

27 de febrero de 2021

Finalización del estudio (Actual)

2 de marzo de 2021

Fechas de registro del estudio

Enviado por primera vez

2 de febrero de 2020

Primero enviado que cumplió con los criterios de control de calidad

4 de febrero de 2020

Publicado por primera vez (Actual)

5 de febrero de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de marzo de 2021

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

2 de marzo de 2021

Última verificación

1 de marzo de 2021

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

Estudia un producto de dispositivo 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. .

Ensayos clínicos sobre Enfermedad de Parkinson

Ensayos clínicos sobre DBS

3
Suscribir