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临床试验/NCT05467657
NCT05467657已完成不适用

Efficacy of Repetitive Transcranial Magnetic Stimulation of the Somatosensory Cortex on Motor Learning

Neuron, Spain2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Change in electroencephalographic activity

研究概览

简要总结

The purpose of this study is to know the efficacy about the application of repetitive transcranial magnetic stimulation (rTMS) on the somatosensory cortex (S1) to enhance motor function in people with stroke.

详细描述

Subjects will attend the Neuron rehabilitation clinic or La Beata Hospital on their own to begin a rehabilitation program. After being recruited for the study and signing informed consent an electroencephalography test (EEG) will be performed to determine the absence of ectopic foci and to reduce risks during the treatment process with repetitive transcranial magnetic stimulation (rTMS).

One assessor will be in charge of carrying out the rest of the neurophysiological tests, so the Resting Motor Treshold (RMT) will be collected. To finalise the assessment, a second evaluator will test sensory aspects with the two-point discrimination test, the Semmes-Wenstein monofilaments, the pinprick test and the sterognosia test, and motor aspects by means of the ARAT test.

Once the assessment is completed, the participant will be assigned to the control or experimental group through a randomisation process carried out by another person in the research group using GraphPad software. The control group treatment will consist of a daily one-hour session of 30 minutes of task-oriented training (TOT) and 30 minutes of robotic-assisted therapy (RAT), for 5 days per week, to which the rTMS placebo treatment will be added. To achieve the placebo, the localisation of the area to be stimulated will be carried out but the coil will be placed in a vertical position so the current wil not go through the skull and the patient will just feel the vibration, communicating to the participant that it is likely that during the stimulation process he/she will not feel anything.

Participants in the experimental group will receive one hour of rehabilitation therapy daily with 30 minutes of TOT and 30 minutes of RAT, 5 days per week, and rTMS will be applied. This process will comprise 5 weekly sessions of excitatory stimulation over the primary somatosensory area of the participant's affected side. For this purpose, the motor area will be localised and a coil will be placed 2 cm posterior to it. An isolated pulse will be applied to the stimulation area to ensure that the coil is not placed over the motor area using 110% of the motor resting threshold. After this, 24 trains of 5 Hz at an intensity of 90% of the motor resting threshold will be applied for 10 seconds, with a rest between series of 5 seconds (a total of 1200 pulses).

Finally, once the treatment period is over, after 20 sessions, the assessment will be carried out again, recording the initial tests in the same order by the same assessors.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having suffered an ischaemic or haemorrhagic stroke with more than 3 months of evolution
  • Presenting a score >21 points on the Mini-mental State Examination scale.

排除标准

  • Severe impairment of upper limb motor function (<15 points on the Fugl-Meyer Assessment Upper Extremity scale)
  • Any contraindications to rTMS, such as metal implants, history of epileptic seizures or taking medication that lowers the seizure threshold
  • Previous history of neurological pathology.

结局指标

主要结局

Change in electroencephalographic activity

时间窗: Change from Baseline in electroencephalographic activity at 4 weeks

The electrical signal evoked by the motor cortex when realizing a movement. It will be measured with an electroencephalograph

次要结局

  • Changes in Sensitivity(Change from Baseline in Sensitivity at 4 weeks)
  • Changes in Motor learning(Change from Baseline in Motor learning at 4 weeks)
  • Changes in Resting Motor Treshold(Change from Baseline in Resting Motor Treshold at 4 weeks)
  • Changes in Esterognosia(Change from Baseline in esterognosia at 4 weeks)

研究者

发起方
Neuron, Spain
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alfredo Lerín Calvo

Physical Therapist

Neuron, Spain

研究点 (2)

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