NCT06043765招募中不适用
TRUE-GRIT: Reducing Cognitive Impairment in Glioma with Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
Linda Douw2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年3月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of patients completing intervention and study protocol
研究概览
简要总结
The TRUE-GRIT study will assess the feasibility of a study protocol investigating the efficacy of a combination therapy consisting of cognitive strategy training (CST) and repetitive transcranial magnetic stimulation (rTMS) to reduce cognitive impairment in adult glioma patients. This study is part of the GRIP-project, a project aimed at investigating interventions for improving quality of life in brain tumor patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Histological diagnosis of diffuse glioma (WHO grade 2,3, or 4)
- •Subjective cognitive impairment, defined as CFQ-score ≥ 44
- •Being able to give informed consent and undergo treatment and measurements based on researchers insight
- •Stable disease, i.e. no oncological treatment for ≤ 2 months prior to inclusion; no radiological progression on the most recent MRI, not older than 6 months, and no clinical progression at inclusion
- •Stable dosage (for at least 8 weeks) of anti-epileptic medication
排除标准
- •Current pregnancy or have given birth less than three months ago
- •Current other treatment for cognitive complaints
- •Karnofsky performance score <70
- •A tumor located in the parietal cortex
- •TMS exclusion: implanted medical devices (e.g. pacemaker, deep brain stimulator, cochlear implants, medical infusion device, etc.); metal in the body; sleep deprivation
- •MRI exclusion: extreme claustrophobia or metallic objects in or on the body
结局指标
主要结局
Number of patients completing intervention and study protocol
时间窗: Baseline versus directly post-intervention (max. 11 weeks after baseline)
The feasibility will be assessed by number of patients completing the intervention and obligatory study measurements
次要结局
- Tolerability and side effects of the combination therapy(Weekly during the intervention (7 weeks))
研究者
Linda Douw
Associate Professor
Amsterdam UMC, location VUmc
研究点 (2)
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