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临床试验/NCT01786005
NCT01786005Unknown4 期

Antispastic Effect of Transcranial Magnetic Stimulation in Patients With Cerebral and Spinal Spasticity

Russian Academy of Medical Sciences2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2013年2月最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
60
试验地点
2
主要终点
Stroke

研究概览

简要总结

Spasticity - movement disorder, which is part of the syndrome of defeat top motor-neuron, characterized by the rate-dependent increase in muscle tone and increased dry-core reflections from hyperexcitability of stretch receptors (Lance, 1980). Spasticity - a frequent symptom of neurological diseases (Valero-Cabre, Pascual-Leone, 2005) and may be accompanied by such a disorders consequences of stroke, multiple sclerosis, head trauma and spinal cord, cerebral palsy, etc. The magnitude and severity of spasticity depends on the level of the lesion, the duration of its existence from the time before the disease, and possible plastic changes in axons and synapses on the affected level. There are two basic models of spasticity: cerebral (hemiplegic) and spinal (paraplegicheskaya) (Nikitin, 2005). Cerebral model appears with the direct injury of the brain and is characterized by increased excitability of monosynaptic reflexes with the rapid development of pathological ref-plexes and characteristic hemiplegic posture. Model is characterized by spinal spasticity opposite lower segmental inhibition polysynaptic reflexes slow increase of nervous excitability due to the mechanism of cumulative excitation perevozbuzhdeniem flexor and razgibate-ing, as well as expansion of the area of segmental responses (Nikitin, 2005). As spinal and cerebral spasticity are extremely difficult corrected by standard medical clinic and physiotherapy methods. In this regard, in the world literature actively searched for addi-tional search correct this symptom. A new modern methods that could affect the syndrome of spasticity is rhythmic transcranial magnetic stimulation (Mori et al., 2009).

详细描述

Spasticity associated with excessive activation of the stretch reflex, the second occurs when the upper motor neuron injury (Young, 1994), which leads to a reduction of spinal inhibition, manifested in the reduction of presynaptic inhibition of Ia afferents coming from muscle spindles flexor (Nielsen et al., 1995 ) and disinapticheskogo reciprocal Ia inhibition of antagonist muscle afferents (Meunier and Pierrot-Deseilligny, 1998; Nielsen et al., 2007), abnormal activity of Ib afferents from tendon Golgi complex (autogenous Ib inhibition), resulting in relief instead of inhibiting alpha-motoneurons ( Delwaide and Olivier, 1988), the deterioration of motor neurons inhibit rekkurentnogo Renshaw cells (Katz and Pier-rot-Deseilligny, 1982, 1999).

There are two basic models of spasticity: cerebral (hemiplegic) and spinal (paraplegicheskaya) (Nikitin, 2005). Cerebral model shines through direct injury of the brain and is characterized by increased excitability of the monosynaptic reflexes with quick reflexes and the development of pathological characteristic hemiplegic posture. Model is characterized by spinal spasticity opposite lower segmental inhibition polysynaptic reflexes slow increase of nervous excitability due to the mechanism of cumulative excitation overexcitation of the flexor and extensor muscles, as well as expansion of the area of segmental responses (Nikitin, 2005). According to recent studies the mechanisms of cerebral and spinal spasticity are different.

According to most researchers increased activity (excitability) of the motor cortex can increase the inhibitory effect of the corticospinal tract and reduce hyperactivity gamma and alpha motor neurons (Valero-Cabre, Pascual-Leone, 2005; Valero-Cabre et al., 2001; Valle et al. , 2007). According to this statement is a special place in the methods of correction of spasticity can take neuromodulation techniques, one of which is a rhythmic transcranial magnetic stimulation (RTMS). In the widely discussed mechanisms of action RTMS to reduce spasticity, explaining its efficacy in MS, spinal cord injury, stroke and cerebral palsy (Nielsen et al., 1996; Kumru et al., 2010; Mori et al., 2011). However, to date, conclusive evidence explaining the mechanisms reduce both spinal and cerebral spasticity under the RTMS not.

From this point of view, it is particularly interesting to study the excitability of the motor cortex by paired TMS to the study of phenomena vnutrikorkovogo inhibition of motor response (SISI in English literature) and vnutrikorkovogo facilitate induced motor response (ICF in the English language), which allow to study the mechanisms of differentiated inhibition and excitation in central nervous system at different levels (Chen et al., 1998).

Transcranial magnetic stimulation (TMS) is a technique that, on the one hand, it can be considered as a way to assess neyroplasticheskih processes, and on the other, the special modes, as neyromoduliruyuschego impact.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The age of the patients and healthy volunteers from 18 to 70 years
  • persons with confirmed and verified lesion of the central nervous system (the effects of CVD, multiple sclerosis, traumatic brain injury, SMC) with symptoms of spasticity any vyrazhenngosti;
  • informed consent;
  • healthy volunteers who gave informed consent to participate in the study.
  • The criteria included:
  • The presence of an implanted pacemaker, intracardiac catheters, electronic pumps;
  • The difficult patient, requiring the maintenance of vital functions by hardware (mechanical ventilation, continuous application infusomats), including an increase of neurological symptoms after 8 days from the start of CVD, acute myocardial infarction, venous thrombosis of the lower extremities, episodes of pulmonary embolism;
  • The severity of the neurological deficit, which does not allow the patient to go through 10 meters (you can use an additional support);
  • Pregnancy or possibility of pregnancy in women of childbearing age (before menopause), according to a pregnancy test;
  • The presence of metal implants or in the head area, located closer than 20 cm from the edge of the surface coil magnetic stimulator, with the exception of the mouth (metal brackets, vascular sutures, metal plate covering defects in the skull, metallic foreign body in the cavity of the skull);
  • Identification of epileptiform activity during the screening EEG prior to the study;
  • Epilepsy or seizures in history;
  • Failure of a patient to participate in the study;

排除标准

  • Identification of the study a total intolerance to a pulsed magnetic field;
  • Development after inclusion of acute myocardial infarction and acute ischemic;
  • Installation of the pacemaker, intracardiac catheters or operations on the brain, requiring the abandonment of metal objects in the cranial cavity;
  • Pregnancy;
  • Enhancement of the patient, which requires the maintenance of vital functions by hardware (mechanical ventilation, continuous application infusomats);
  • The emergence of an epileptic seizure in response to rhythmic TMS;
  • Failure of the patient to continue participation in the study;

研究组 & 干预措施

Sham

Sham Comparator

Imitation of stimulation.

干预措施: Transcranial magnetic stimulation (Device)

High-frequency stimulation

Experimental

High-frequency stimulation

干预措施: Transcranial magnetic stimulation (Device)

TBS Theta burst stimulation

Experimental

TBS Theta burst stimulation

干预措施: Transcranial magnetic stimulation (Device)

Low-frequency stimulation

Experimental

Low-frequency stimulation

干预措施: Transcranial magnetic stimulation (Device)

结局指标

主要结局

Stroke

时间窗: 20 days

Epileptic seizure

时间窗: 20 days

次要结局

  • The patient is discharged from clinic(20 days)

研究者

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

Chervyakov Alexander

Russian academy of medical science

Russian Academy of Medical Sciences

研究点 (2)

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