跳至主要内容
临床试验/NCT06401057
NCT06401057招募中不适用

Register for Longitudinal Recording of Brain Function in Patients With Brain Diseases

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
cortical data

研究概览

简要总结

The aim of this observational register study is to establish a registry that completely records and compiles the data from routinely performed technical examinations (navigated transcranial magnetic stimulation, intraoperative neuromonitoring and stimulation, MRI imaging including tractography and connectome) and clinical tests over time (pre-, intra- and postoperative, under adjuvant therapy, as part of follow-up care) of patients with intracranial masses and lesions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Intracranial lesion
  • •Age ≥ 18 years
  • •Written consent to participate in the study

排除标准

  • •Age < 18 years
  • •Patients not able to give consent
  • •Patients with intracranial ferromagnetic metal implants
  • •Patients with implanted electronic devices

结局指标

主要结局

cortical data

时间窗: until last patient FU up to 48 months

cortical nTMS-Data - distribution according the cortical parellation system

Cognitive status

时间窗: until last patient FU up to 48 months

Higher cognitive functions - determined by the Montreal Cognitive Assessment (MocA)

Motor status

时间窗: until last patient FU up to 48 months

Motor function according to the BMRC scale

Fiber tracts

时间窗: until last patient FU up to 48 months

fractional anisotropy of fiber tracts

structural imaging (Connectome)

时间窗: until last patient FU up to 48 months

characteristics of Connectome and Disconnectome analysis (Global Efficiency value)

Language status

时间窗: until last patient FU up to 48 months

Language function tested by the Aphasia Check List

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Schwendner Maximilian

Principal Investigator

University Hospital Heidelberg

研究点 (1)

Loading locations...

相似试验