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临床试验/NCT03228472
NCT03228472招募中不适用

Noninvasive Brain Stimulation Training to Help Recover Brain-related Symptoms

Neuromed IRCCS2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年11月22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
100
试验地点
2
主要终点
Barthel's Activities of Daily Living (ADL) (O'Sullivan et al 2007)

研究概览

简要总结

Non-invasive cerebral stimulation techniques have shown potential in the treatment of neurological disorders such as chronic pain, Parkinson's disease, neglect, aphasia, memory, engine deficit and epilepsy In general, non-invasive cerebral stimulation techniques have been shown to be able to induce changes in cortical plasticity that may last even beyond the end of the stimulation period. Considering this potential, there is growing interest in the application of these therapeutic techniques.

Hypotheses Based on these assumptions, the underlying hypothesis behind this project is that the therapeutic use of cranial - electrical or magnetic stimulation - can aid the recovery of various brain injury symptoms.

Specific objectives This study aims to provide preliminary data about the benefits of using cortical stimulation to recover various brain injury symptoms. This will be made possible thanks to the specific skills of a multidisciplinary team of neurologists and physiatrists, healthcare professionals such as physiotherapists, occupational therapists, psychologists, speech therapists and the support of a biomedical engineer. These professional figures are already available at the UCK Neurosurgery of the IRCCS Neuromed directed by the proposer and actively collaborate to optimize the therapeutic exercise of patients with neurological damage.

详细描述

Introduction TMS is a non-invasive neuronal stimulation of surface areas of the brain that since its introduction in 1985 has been frequently used in neurology as a diagnostic and research tool. TMS uses magnetic fields to induce electrical currents that cross the nervous tissue depolarizing neurons, and reproduced motions generated are recorded as electromyograph potentials. TMS is able to explore the functionality of the cortical-spinal system, measure cortical excitability, mapcortical features, and evaluate brain modulators.

Repetitive transcranial magnetic stimulation (rTMS) is frequently used in the experimental field for cortical function scans and modulation of the intrinsic cortical plasticity. In particular, high frequency rTMS has facilitating effects on cortico-spinal excitability and the low-frequency one is usually inhibitory. rTMS is a method of extreme interest for the possible therapeutic role in conditions of altered cerebral excitability, both psychiatric (schizophrenia, posttraumatic stress disorder, obsessive-compulsive disorder, major depression) and neurological (epilepsy , stroke, degenerative diseases). At experimental level, the actual stimulation is compared with an inactive stimulus called sham, which acts as a control condition.

Direct Transcranial Electric Stimulation (tDCS) requires the application of weak electrical currents directly to the head for several minutes. These currents generate an electric field modulating neural activity based on the application mode. tDCS alters the rate of discharge of neurons. In fact, cathodic polarization applied to the motor cortex can induce a robust reduction in cortical excitability, while anodic polarization increases the excitability of the motor cortex. The short-term effects of tDCS are probably due to a change in neural membrane polarization. Similarly to rTMS, these changes last even after the end of stimulation for periods ranging from minutes to hours. Thus, tDCS can modify performance in many cognitive tasks.

Non-invasive cerebral stimulation have demonstrated a potential for the treatment of neurological disorders such as chronic pain, Parkinson's disease, neglect, aphasia, memory, motor deficiency and epilepsy. In general, non-invasive brain stimulation techniques have shown to induce changes in cortical plasticity that may last even beyond the end of the stimulation period. Considering this potential, there is an increasing interest in the application of these techniques in the therapeutic field.

In our study, we suggest evaluating any variations in the muscular tone of the lower limbs as a result of high frequency repetitive transcranial magnetic stimulation (rTMS) in patients with multiple sclerosis with relapsing-remitting pattern without evidence of medullary demyelination areas. rTMS allows modulation of intracortical excitability and can therefore modify the control of spinal excitability.

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
None

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

入选标准

  • The sample estimate was made by analogy after a literature analysis. Considering the risk of abandonment quite high, our intention is to recruit at least 100 subjects in a population of patients with cerebral injury who are involved in the neurological department of I.R.R.C.S. Neuromed by Pozzilli, featuring the symptoms described below in the inclusion criteria
  • Inclusion criteria:
  • Males or females aged between 18 and 80;
  • Presence of: Disinfection, Multiple Sclerosis, Depression, Sensory Disorder or Neuropathic Pain;
  • Female subjects can not be pregnant, can not breastfeed, have been born at least three months before the beginning of the study, undertake not to schedule a pregnancy for the duration of the study;
  • Patients should be able to follow protocol guidelines throughout the study;
  • Patients should be able to understand the aims and risks of the study;
  • Signature of informed consent, approved by our Ethics Committee.

排除标准

  • Tumors or systemic infections;
  • Patients with impaired hepatic function (ALT> 3 x Upper Limit Normal (ULN), Alkaline Phosphatase> 2 x ULN, bilirubin tot> 2 x ULN if associated with any increase in ALT or alkaline phosphatase); Severe or moderate renal failure;
  • Patients with TMS or tDCS (pacemaker, intracerebral metal clip, epilepsy ...)
  • Patients with other pathologies which, according to the scientific officer's opinion, prevent recruitment;
  • Patients unable to even partially understand and want.

结局指标

主要结局

Barthel's Activities of Daily Living (ADL) (O'Sullivan et al 2007)

时间窗: up to 3 years

Abilities of daily living

stroke

时间窗: up to 3 years

NIH Stroke Scale / Score (NIHSS)

disability

时间窗: up to 3 years

Expanded Disability Status Scale (EDSS) (Kurtzke, 1983)

parkinson

时间窗: up to 3 years

Unified Parkinson's Disease Rating Scale (Rammer et al. )

FIM

时间窗: up to 3 years

Functional Independence Measurement (FIM) (Chumney et al., 2010)

depression

时间窗: up to 3 years

Beck Depression Inventory (BDI) (Beck, 1972)

次要结局

  • Cognition(up to 3 years)
  • locomotion(up to 3 years)
  • neuronal plasticity(up to 3 years)
  • deglutition(up to 3 years)
  • posture(up to 3 years)

研究者

发起方
Neuromed IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Stampanoni Bassi

Principal Investigator

Neuromed IRCCS

研究点 (2)

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