Virtual Remote Assessment of Transcranial Electrical Stimulation for Parkinson's Disease Motor Symptoms
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in MDS-UPDRS Part III Motor Scores
研究概览
简要总结
This study tests a new, non-invasive brain stimulation device called Sphere V3.0 to help improve movement problems in people with Parkinson's disease. The device delivers gentle electrical signals to the scalp using small electrodes placed on the head.
Participants will use the device at home for 13 minutes each weekday (Monday through Friday) for 3 weeks, then be monitored for another 3 weeks without treatment. The entire study lasts 6 weeks and is conducted virtually through video calls and online assessments.
The investigators will measure changes in Parkinson's symptoms using standard rating scales and video recordings of movement tasks like walking and hand tremor tests. Participants will also record videos of their movements at home using their smartphone or computer.
The study includes 30 adults aged 18-80 who have been diagnosed with Parkinson's disease and have stable medication for at least 4 weeks. Participants must have reliable internet access and be able to follow the treatment schedule.
The main goal is to see if this brain stimulation treatment can reduce motor symptoms like tremor, stiffness, and slowness of movement. The investigators will also check if any improvements last after treatment ends and monitor for any side effects.
All participants receive the active device treatment - there is no placebo group. The device has been tested in over 250 people in previous studies with no serious adverse events reported
详细描述
BACKGROUND AND RATIONALE:
Transcranial electrical stimulation (tES) represents a promising non-invasive approach for treating Parkinson's disease motor symptoms. The Sphere V3.0 device utilizes amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS) with randomized timing parameters to target motor cortex regions. Previous clinical experience with this technology includes over 250 participants across multiple studies with over 30,000 hours of treatment data and no adverse events recorded.
VIRTUAL STUDY DESIGN:
This fully remote study leverages HIPAA-compliant telehealth platforms to conduct all assessments and monitoring virtually. Participants receive the device via mail with comprehensive training materials and video tutorials. Virtual onboarding includes supervised device setup and electrode placement training via video call.
DEVICE SPECIFICATIONS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Adults 18-80 years with confirmed diagnosis of Parkinson's Disease
- •Hoehn & Yahr stages 1-4
- •Stable medication regimen for 4+ weeks prior to enrollment
- •Reliable internet access and telehealth capability
- •Ability to provide informed consent
- •Willingness to comply with treatment protocols and follow-up procedures
排除标准
- •Metallic head/neck implants (excluding dental fillings)
- •Pregnancy or nursing status
- •Severe skin conditions at electrode placement sites
- •History of epilepsy or seizures (unless technology specifically indicated)
- •Recent stroke or traumatic brain injury (within 6 months)
- •Severe cognitive impairment preventing treatment understanding
- •Any neurological disorders contraindicating transcranial electrical stimulation
- •Current participation in other clinical trials
- •Inability to commit to full treatment and follow-up schedule
研究组 & 干预措施
Active Treatment Arm
All participants receive active transcranial electrical stimulation treatment using the Sphere V3.0 device. Treatment consists of 13-minute daily sessions Monday through Friday for 3 weeks (15 total sessions), followed by 3 weeks of follow-up monitoring without device use. The device delivers amplitude-modulated transcranial pulsed random noise stimulation (am-tPRNS) with current intensity up to 4mA through a 4-electrode array placed on the scalp targeting motor cortex regions.
干预措施: Transcranial Electrical Stimulation Device (Device)
结局指标
主要结局
Change in MDS-UPDRS Part III Motor Scores
时间窗: Baseline to Week 3 (end of treatment)
Change from baseline to end of treatment in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III motor examination scores. The MDS-UPDRS Part III assesses motor signs of Parkinson's disease including tremor, rigidity, bradykinesia, and postural instability. Scores range from 0-132 with higher scores indicating worse motor function. All assessments conducted by qualified medical personnel including physicians, certified research coordinators, or trained clinical research assistants under physician supervision.
次要结局
未报告次要终点
研究者
Mohammed Abouelsoud
CEO, Neurotechnologist
U: The Mind Company