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临床试验/NCT04501731
NCT04501731Unknown不适用

Controlling Coordination After Childhood Cerebellar Cancer - Pilot Study

University of Nottingham1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年4月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Completion rate of the sessions of TMS, MRI and motor tasks

研究概览

简要总结

Posterior fossa tumours (PFT) account for 2/3 of childhood brain cancers. They can be highly malignant requiring combined chemotherapy and radiotherapy post-surgery for a >50% chance of cure. PFT frequently involve the cerebellum which is responsible for coordinating movement, balance, emotional control, and links closely to control of affect and executive function. PFT survivors show highly variable profiles for cognitive and sensorimotor functioning which are influenced strongly by the severity of the pre-diagnostic or post-surgical brain injury

State-of-the-art magnetic resonance imaging (MRI) scans can allow to measure a variety of different biological processes in the brain, and the investigators believe that some of these MRI measures (called MRI biomarkers) have the potential to improve our ability to understand and monitor consequences of the ablative brain surgery and complex mechanisms of motor skills recovery. Biomarkers are very important for the development of intervention because 1) they help understand the recuperation process and 2) they allow to effectively assess whether or not a treatment or intervention works.

Transcranial magnetic stimulation (TMS) is a powerful non-invasive neuro-modulatory intervention that has the potential to evaluate the integrity of the nervous tracts from the brain to the hand. It is a procedure that applies magnetic pulses on the surface of the scalp to reach underlying brain tissue. TMS has built a reputable status among neuro-rehabilitative research, and there is currently a major effort to translate the positive research findings into clinically useful therapeutic strategies.

This study is therefore an important first step towards understanding how potential MRI biomarkers and responses to TMS relate to motor symptoms in PFT young survivors. Once completed, this study will allow the investigators to select the most promising MRI biomarkers and TMS protocols to take forward into future treatment trials. The investigators aim to stimulate the recovery of coordination skills, help the development of targeted therapies, and consequently improve long-term quality of life in children and young people with history of brain tumour.

The proposed research intends to prove the feasibility of such brain stimulation and imaging and collect some preliminary measures

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
16 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Able to undergo MRI scan without sedation or general anaesthetic
  • Able to give informed consent.

排除标准

  • History of seizure
  • Current cancer or post surgery treatment
  • Contraindication to TMS or MRI
  • Pregnancy

结局指标

主要结局

Completion rate of the sessions of TMS, MRI and motor tasks

时间窗: 6 months

Measure of quality of MRI images (participants motion) - Feasibility will be confirmed if 50% or more of these participants complete the TMS session

5C-pilot Satisfaction Questionnaire

时间窗: 6 months

Participants rating their experience of MRI, TMS and motor assessment

次要结局

  • Motor performance (PFT vs control) - Grooved pegboard(1 year)
  • Anatomical MRI metrics (PFT vs control)(1 year)
  • Diffusion MRI metrics (PFT vs control)(1 year)
  • Single-pulse TMS metrics (PFT vs control)(1 year)
  • Dual-pulse TMS metrics (PFT vs control)(1 year)
  • fMRI metrics (PFT vs control)(1 year)
  • Quality of life of PFT survivors: FACT-Peds-Br Questionnaire(6 months)
  • Motor performance (PFT vs control) - Grip force(1 year)
  • Motor performance (PFT vs control) - Reaching and grasping task(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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