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临床试验/NCT02740530
NCT02740530终止不适用

Improving Mobility and Cognition in Older Adults: Establishment of an Interdisciplinary Clinical Research Program Using Non-Invasive Brain Stimulation

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
25
试验地点
1
主要终点
Gait velocity - cm/s

研究概览

简要总结

This study aims to test the efficacy of a type of non-invasive brain stimulation (NIBS), known as repetitive transcranial magnetic (rTMS) stimulation, in improving mobility, particularly gait stability and variability, and executive dysfunction in older adults. The study will be conducted in forty older adults (≥60 years) with a diagnosis of executive dysfunction.

详细描述

The proposed study using rTMS will build upon the investigators previous work demonstrating the link between cognitive impairment, particularly executive dysfunction, and mobility/gait abnormalities in older adults, even in those labeled as "cognitively normal". Emerging evidence demonstrates that executive dysfunction is an early phenomenon in the pathway to mobility disability and subtle changes in executive function are independently associated with future falls. The investigators have piloted studies showing that pharmacological enhancement of executive function, can improve gait-motor performance and, potentially, reduce mobility decline and risk of falls. This supports the rationale for a promising intervention: enhancing cognition to prevent mobility decline and reduce risk of falls. The long-term goal is to create a clinical research program to apply rTMS as an early novel intervention for cognitive/motor interaction to ultimately delay the onset of cognitive and mobility disabilities and their devastating consequences, dementia and falls, in older adults. However, it is first necessary to study a smaller group of seniors to plan for recruitment, study retention and compliance, and to gather preliminary data as proof of principle before proceeding to a larger clinical trial.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Having executive dysfunction (defined as score below 11 out of a possible 13 in the "Montreal Cognitive Assessment -MoCA- executive score index")
  • Age 60 years and older
  • English speaking
  • Able to ambulate 10m independently without any gait aid (eg. walker, cane)

排除标准

  • Unable to understand or communicate in English
  • Parkinsonism or any neurological disorder with residual motor deficit (eg. Major stroke, epilepsy)
  • Musculoskeletal disorder detected by clinical examination which affects gait performance -Active osteoarthritis affecting lower limbs (American College of Rheumatology criteria)
  • Severe depression operationalized as Geriatric Depression Scale (GDS) score>10
  • TMS specific exclusion criteria:
  • Persons with metal anywhere in the head, excluding the mouth, including shrapnel, and screws and clips from surgical procedures
  • Persons with cardiac pacemakers, implanted medication pumps, electrodes inside the heart
  • Unstable heart disease
  • Persons with increased intracranial pressure, as in acute large infarctions or trauma
  • Previous major stroke, history seizure, Parkinson D, Huntington D.
  • History of schizophrenia/schizo-affective disorder, substance use disorder within 1 year of study

研究组 & 干预措施

rTMS Active

Experimental

High frequency pulsed repetitive magnetic stimulation at 100 % resting motor threshold will be delivered using a figure of 8 air film cooled coil attached to the Magstim® Rapid 2 machine. Resting motor threshold will be determined minimum energy needed to elicit the a reliable visible contraction in the contra-lateral first interosseous muscle using single pulse rTMS applied to the area between C1-C3 using the 10-20 international EEG electrode system. For stimulation, the coil will be positioned on the scalp corresponding to F4 then F3 electrode position using the 10-20 international EEG system. Real stimulation will consist of delivering 1200 pulses at 20 hz frequency to F4 location followed by the same stimulation to F3. The total time needed to deliver pulses is 20 minutes.

干预措施: Magstim® Rapid 2 machine (Device)

rTMS Sham

Placebo Comparator

Sham stimulation will also involve delivering the same stimulus but with angulation of the coil at 45 degrees, which will give similar scalp sensation but unlikely to deliver magnetic stimulation to the cortex

干预措施: Magstim® Rapid 2 machine (Device)

结局指标

主要结局

Gait velocity - cm/s

时间窗: Seven days

次要结局

  • Executive function, assessed as time to take to complete Trail Making A and B (TMT A and B) in seconds.(seven days)

研究者

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

Manuel Montero Odasso

MD, PhD, FRCPC

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

研究点 (1)

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