Development and Clinical Validation of a Rehabilitation Platform Based on Neuromodulation for Patients With Motor Control Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Motor changes
研究概览
简要总结
Movement disorders are neurological syndromes leading to excessive movements or to limited control of voluntary and automatic movements. Many of these disorders are not life-threatening but represent serious difficulties in carrying out the activities of daily living and reduce patient's independence and quality of life.
This project NeuroMOD (neuromodulation for patients with disorders of motor control) proposes the development of a neuromodulation-based platform for the rehabilitation and restoration of motor and cognitive functions of patients suffering from Parkinson's disease (PD). Our project will focus on the application of a novel neurorehabilitation strategy, its functional and clinical validation, and on the evaluation of the impact of the use of the technologies involved in the musculoskeletal and the nervous system as well as user behavior.
Parkinson's disease was selected as target pathology since it represents a paradigm of motor disorder diseases.
Parkinson's disease affects adults and has a very high prevalence and a very high functional impact.
In order to achieve this objective, we have defined the following research areas:
Subproject 1. NeuroMOD: development of a neuromodulation platform composed by a TMS system, and an EMG (electromyography) and EEG (electroencephalography) system in combination with a system of virtual reality based on immersive glasses.
Subproject 2. NeuroMOD-PD: development of therapies and evaluation of clinical evidence and motor and cognitive impact of NeuroMOD in the rehabilitation of patients suffering from Parkinson's disease impact.
Subproject 3. NeuroMOD-Image: development of neuroimaging techniques to investigate the brain areas affected by the proposed therapies and temporary terms that neural plasticity is induced and evolves in Parkinson´s Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Final outcomes evaluators are blinded. Clinical evaluation is performed using videotaped neurological examination. Neurophysiological evaluation is done with the raw data recorded during the sessions.
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
- 是
入选标准
- •Idiopathic Parkinsons Disease
- •Hoehn Yahr Scale I-III
- •No drug changes in the last 90 days
排除标准
- •Exclusion Criteria:
- •Dementia (Minimental scale score <25)
- •Dependency (modified Rankin scale > 3)
- •Pregnancy or pregnancy plans
- •Pacemaker
- •Implanted metal devices
- •cochlear implants
- •claustrophobia
- •drug infusion pumps
- •epilepsy / epileptiform anomalies in electroencephalography (EEG)
- •known structural alterations in magnetic resonance imaging (MRI)
- •Atypical Parkinsonism
- •Previous repetitive transcranial magnetic stimulation (rTMS)
- •Severe comorbidity (cancer, severe debilitating diseases, etc.)
结局指标
主要结局
Motor changes
时间窗: t2(2 weeks after finishing the protocol)
UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) part III ( total values from 0-68, higher score worse clinical situation)
Neurophysiological cortical changes
时间窗: t2(2 weeks after finishing the protocol)
Cortical silent period measured using transcranial magnetic pulse in M1 and simultaneous register of electromyographical response
次要结局
- Quality of life changes(t2(2 weeks after finishing the protocol))
- Cognitive changes in objective measures of processing speed(t2(2 weeks after finishing the protocol))
- Encephalographic changes(t2(2 weeks after finishing the protocol))