Remotely Supervised Transcranial Direct Current Stimulation for Slowing Disease Progression in Amyotrophic Lateral Sclerosis (ALS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Revised ALS Functioning Rating Scale (ALSFRS-R)
研究概览
简要总结
Most ALS care is centered on patient support and symptom management, making rehabilitation an integral aspect for slowing disease progression, prolonging life span, and increasing quality of life. Brain stimulation has been increasingly explored as a promising neuromodulatory tool to prime motor function in several neurological disorders. We propose a novel mechanism using remotely supervised brain stimulation to preserve motor function in individuals with ALS. This project will also aim to explore the effectiveness of brain stimulation on upper and lower motor neuron mechanisms in individuals with ALS.
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)
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
- 否
入选标准
- •Diagnosis of possible, probable, or definite amyotrophic lateral sclerosis according to El Escorial revised criteria
- •Spinal onset ALS with initial weakness in the upper or lower extremity.
- •Diagnosed with ALS within the past 5 years
- •1-2 point change in pre-slope of the ALSFRS-R at time of enrollment (ratio of drop in score from 48 to the duration in months from onset of weakness)
- •Score ≥ 2 for "swallowing" of the ALSFRS-R
- •Score ≥ 2 for "walking" of the ALSFRS-R
- •Able to provide informed consent
- •Stable dose of riluzole, edaravone, AMX0035 (Relyvrio) or no medications
- •Availability of a caregiver for remote administration of tDCS
排除标准
- •Subject has bulbar onset ALS
- •Any neurological diagnosis other than ALS
- •Psychiatric disorders
- •Any other concomitant disease that affects prognosis of ALS inclusive of systemic disease, cardiovascular disease, hepatic or renal disorder
- •Tracheostomal or noninvasive ventilation for more than 12 hours per day
- •Enrollment in an on-going ALS pharmaceutical trial
- •Subject plans on moving within 6 months.
- •TMS Exclusion Criteria:
- •Implanted cardiac pacemaker
- •Metal implants in the head or face
- •Unexplained, recurring headaches
- •History of seizures or epilepsy
- •Currently under medication that could increase motor excitability and lower seizure threshold
- •Skull abnormalities or fractures
- •Concussion within the last 6 months
- •Currently pregnant
- •tDCS Exclusion Criteria:
- •Skin hypersensitivity
- •History of contact dermatitis
- •History of allodynia and/or hyperalgesia
- •Any other skin or scalp condition that could be aggravated by tDCS
研究组 & 干预措施
Transcranial Direct Current Stimulation (tDCS)
Facilitatory transcranial direct current stimulation (tDCS)
干预措施: Transcranial Direct Current Stimulation (tDCS) (Other)
Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group
Sham tDCS followed by a switch to anodal tDCS.
干预措施: Sham tDCS + anodal tDCS (Other)
结局指标
主要结局
Change in Revised ALS Functioning Rating Scale (ALSFRS-R)
时间窗: Change from baseline to immediately after training and baseline to 3 months follow up.
This questionnaire evaluates function over time and disease progression in ALS patients with questions related to daily activities such as speech, swallowing, walking, etc. Scores range between 0-48 with higher scores corresponding to more function being retained.
次要结局
- Gait Speed(Change from baseline to immediately after training)
- Ankle Motor Control(Change from baseline to immediately after training and baseline to 3 months follow up.)
- Quality of Life With EuroQol-5D (EQ-5D)(Change from baseline to immediately after training and baseline to 3 months follow up.)
- EuroQual-Visual Analog Scale (EQ-VAS)(Change from baseline to immediately after training)
- Fatigue Severity Scale(Change from baseline to immediately after training.)
- Upper and Lower Motor Neuron Mechanisms Using Transcranial Magnetic Stimulation (TMS)(Change from baseline to immediately after training and baseline to 3 months follow up.)
- Upper and Lower Motor Neuron Mechanisms Using Peripheral Nerve Stimulation (PNS)(Change from baseline to immediately after training and baseline to 3 months follow up.)
研究者
Sangeetha Madhavan
Associate Professor, Physical Therapy
University of Illinois at Chicago