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临床试验/RBR-6sc7tp
RBR-6sc7tp尚未招募未知

Stimulation of the Pontino peduncle nucleus area in patients with Parkinson's disease evaluation of motor results focusing on gait changes falls balance and impact on quality of life - Stimulation of the nucleus area of ??the Pontino peduncle in patients with Parkinson's disease

Faculdade de Medicina da Univeridade de São Paulo0 个研究点开始时间: 2020年8月24日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Intervention

入排标准

入选标准

  • Patients diagnosed with idiopathic PD according to Queen Square Brain Bank criteria 23.
  • The diagnosis will be given by a neurologist specializing in movement disorders.
  • Presence of moderate PD, at least 4 years from the onset of motor symptoms.
  • Persistent motor dysfunction for at least 1 month despite drug adjustment.
  • Patients with moderate to severe gait disturbances and refractory balance to drug treatment.
  • Thus, they should have: score 3 (moderate) or 4 (severe) in items 12 and 13 of part II of the MDS-UPDRS and score 3 (moderate) or 4 (severe) in items 9, 10, 11 and 12 of part III UPDRS being on medication (medication status ON).
  • Cognitive performance appropriate to preoperative care.
  • Understanding of the stimulation system and recognition of adverse events.
  • Willingness of the caregiver or family member, and the patient himself, to come in frequent returns to ensure the best brain stimulation parameters.

排除标准

  • Age under 18 years.
  • Parkinsonism Associated With Other Degenerative Diseases
  • Secondary Parkinsonism.
  • Prior surgical treatment of PD symptoms.
  • Patients without clinical conditions for the surgical procedure due to noncompensated systemic disease.
  • Behavioral disorders and hallucinations associated with dopamine drug use and without drug control.
  • Patients with less than two years of schooling or visually impaired who cannot perform properly on neuropsychological tests.
  • Depression.
  • Dementia associated with PD
  • Refusal to undergo neurosurgical procedure.
  • Refusal to accept the informed consent form.

研究者

发起方
Faculdade de Medicina da Univeridade de São Paulo

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