跳至主要内容
临床试验/NCT05475236
NCT05475236已完成不适用

Brain Networks of Turning Performance With Aging and Stroke

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2023年2月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
360 Degree Turn Duration From Baseline

研究概览

简要总结

Older adults and stroke survivors often have difficulty performing complex walking tasks, due in part to changes in the brain. One task often overlooked is turning, which can lead to injury when performed poorly. The investigators will use non-invasive brain stimulation to assess brain activity and relate those observations to turning performance in older adults and stroke survivors.

详细描述

This study is associated with an ongoing Clinical Trial (NCT03790657) called the CONTROL Walking Study, which combines locomotor learning and a form of non-invasive electrical brain stimulation call transcranial direct current stimulation (tDCS). The CONTROL Walking Study, randomly places participants into one of two experimental groups (transcranial direct current stimulation or sham stimulation). Following group placement participants complete a 2 week long walking and turning locomotor learning intervention while receiving a group dependent the form of tDCS or sham stimulation.

In leveraging the CONTROL Walking Study infrastructure to further examine the neural control of turning while walking, which is often impaired for older adults and people who have had a stroke. This study will assess neurophysiological brain function using transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation as well as assessing multiple forms of turning performance in older adults. Transcranial magnetic stimulation (TMS) will be used to assess cortical inhibitory neurophysiological function in motor networks of the brain. Importantly, recent work demonstrates significant associations between brain excitatory/inhibitory function and turning performance in older adults, although these results remain largely preliminary.

Therefore, the objective of this proposal is to further elucidate associations between neurophysiological function (measured with TMS) and 360 degree and 180 degree turning performance. The investigators will address the following specific aims:

Specific Aim 1 will test the hypothesis that greater cortical inhibition will be associated with shorter turn duration for 360 degree turns and 180 degree turns.

Specific Aim 2 will test the hypothesis that participants with greater baseline cortical inhibition will demonstrate larger 360 degree and 180 degree turning performance gains (i.e., shorter turn durations).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will not be told which group (tDCS or sham) they are assigned to. Outcomes Assessors will not be told which group the participant was randomized to.

入排标准

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

入选标准

  • •age 65 years or older
  • •preferred 10m walking speed < 1.1 m/s
  • •self-report of "some difficulty with walking tasks, such as becoming tired when walking a quarter mile, or when climbing two flights of stairs, or when performing household chores."
  • •Willingness to be randomized to either study group and to participate in all aspects of study assessment and intervention

排除标准

  • •Diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition (Alzheimer's, Parkinson's, stroke, etc.)
  • •Contraindications to non-invasive brain stimulation (e.g., metal in head, wound on scalp)
  • •Contraindications to magnetic resonance imaging (e.g., metal in body, claustrophobia, etc).
  • •Use of medications affecting the central nervous system
  • •severe arthritis, such as awaiting joint replacement
  • •severe obesity (body mass index > 35)
  • •current cardiovascular, lung or renal disease; diabetes; terminal illness
  • •myocardial infarction or major heart surgery in the previous year
  • •cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
  • •current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
  • •uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg)
  • •bone fracture or joint replacement in the previous six months
  • •current participation in physical therapy for lower extremity function or cardiopulmonary rehabilitation
  • •current enrollment in any clinical trial
  • •difficulty communicating with study personnel, and/or non-English speaking
  • •planning to relocate out of the area during the study period
  • •clinical judgment of investigative team regarding safety or non-compliance

研究组 & 干预措施

Sham Stimulation

Sham Comparator

Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.

干预措施: Experimental: Locomotor Learning (Behavioral)

Transcranial Direct Current Simulation

Experimental

Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.

干预措施: Experimental: Locomotor Learning (Behavioral)

结局指标

主要结局

360 Degree Turn Duration From Baseline

时间窗: Measured at follow up visit (approximately three weeks after baseline)

Change in 360 degree turn duration during a 360 degree turn test

180 Degree Turn Duration From Baseline

时间窗: Measured at follow up visit (approximately three weeks after baseline)

Change in 180 degree turn duration as measured during a 2 minute walking task where participants walk back and forth down a corridor.

Duration of Cortical Silent Period (CSP) (ms)

时间窗: 30 minutes, Measured at Baseline

Cortical Silent Period (CSP) is a single-pulse TMS measure of GABA-mediated cortical inhibition, in which stimulation is applied to the motor cortex while participants are activating a target muscle (here, the tibialis anterior muscle), resulting in a brief reduction in muscle activity. CSP is measured as the time during which the muscle activity is less than the pre-simulation muscle activity level until the return of voluntary muscle activity. CSP is measured in milliseconds (ms).

Resting Motor Threshold (Percent of Machine Output)

时间窗: 20 minutes, Measured at Baseline

Resting motor threshold (rMT) is obtained by single-pulse TMS and assesses voltage-gated sodium-channel-mediated cortical excitability. rMT is the minimum intensity (% machine output) of stimulation needed to repeatedly evoke a motor evoked potential (MEP) of at least 50 microvolts in over 50% of trials. It is reported as a percentage of total machine output.

次要结局

  • Katz Independence Questionnaire(Baseline)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验