跳至主要内容
临床试验/NCT03676439
NCT03676439招募中2 期

Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy - Multicenter Double Blind Randomized and Controlled Trial

Sociedad Argenttina de Neuromodulación2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11月18日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
Changes in Modified Ashworth Scale (MAS)

研究概览

简要总结

Lateral cord stimulation (LCS) was discovered by the author as the producer of an average threshold increase for abnormal muscle contraction responses, in experimental pathological conditions, as described and referred.

This physiological effect is proposed to improve tone, motor function and speech, in patients with spasticity of different causes, such as cerebrovascular accident, congenital brain malformations, perinatal anoxia (image called cerebral palsy), sequels of neurosurgery, etc.

Due to its non-invasiveness and possible efficacy, the use of magnetic stimulation is proposed to try to demonstrate its therapeutic utility.

This is the clinical test of phase 2/3 of the method, in the future, and how its use could be extended, if the results were positive, its indications could be extended to other pathological conditions, giving a greater spectrum of spastic patients, potentially benefited

详细描述

Cerebral Palsy (CP) is a chronic and non-progressive morbid disease that affects psychomotor development, with multiple etiologies that share a common condition of acquired perinatal anomalies during development.

The manifestations are multiple and varied, with more frequent motor disorders, speech disorders, mental retardation, spasticity, dystonia, etc.. About a third of these patients have a normal IQ, for whom those signs are more disabling than for others, and for refractory speech problems there is no therapy available These subjects have generally been unsuccessfully treated with medications, botulinum toxin injections, rehabilitation or kinesic orthosis, maintaining their abnormal stable conditions at the end of childhood or early adulthood.

The rational for this clinical trial is that the author has demonstrated the reduction of the excitability threshold of the nociceptive response by electrically stimulating the lateral spinal cord in an animal model, therefore, its possible beneficial action on abnormal muscle tone, somatic motor functions and improvement of speech, by this method.

Spastic Cerebral Palsy has been chosen as a targeted population, because it use to be a chronic and irreversible condition with few therapeutic options, ineffective and frequent complications.

It is of ancient knowledge that electric currents can alter the functions of the Nervous System In the last decades there was a refinement of these techniques of stimulation, being able to emphasize especially the Transcranial or Spinal Magnetic Stimulation (TMS). This therapeutic method, developed in the eighties, is able to modulate brain activity, through the stimulation of limited cortical or spinal areas, with minimal side effects, which is applied through a coil that produces an alternating electrical current.

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
Double (Participant, Outcomes Assessor)

盲法说明

Patient and independent evaluator

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 16 years or older.
  • Spastic Cerebral Palsy with stable condition.
  • Motor disability unilateral or predominantly unilateral.
  • Clinically evident speech disorders.
  • Normal or slightly subnormal intellectual coefficient (I.Q 80 or more)
  • Absence of psychiatric disorders

排除标准

  • Cardiac or severe respiratory disorders.
  • Steady abnormal postures (except possible orthopedic surgical correction)
  • Recurrent chronic bronchial or pulmonary infections.
  • Psychiatric disorders
  • Chronic recurrent urinary infections
  • Severe osteoporosis in affected limbs
  • Chronic skin ulcers
  • Drug addiction.
  • Episodes of Status Epileptucus
  • Personal history, or in close relatives, of medical legal complaint

结局指标

主要结局

Changes in Modified Ashworth Scale (MAS)

时间窗: One pre interventional and monthly - up to three months - post interventional

Scale evaluationg muscle stiffness, from 0(normal) to 5 (maximal rigidity). It wiil be employed to evaluate the spasticity related to limbs.

Changes in Functional Independence measure (FIM) for the speech.

时间窗: One pre interventional and monthly - up to three months - post interventional

The FIM measures what an individual can perform - Only the ability for communication, comprehension and expression, will be evaluated to assess speech changes

次要结局

  • Changes in Barthel's Scale(One pre interventional and monthly - up to three months - post interventional)

研究者

发起方
Sociedad Argenttina de Neuromodulación
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan Carlos M. Andreani MD

MD

Sociedad Argenttina de Neuromodulación

研究点 (2)

Loading locations...

相似试验