NCT07357428招募中不适用
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) to Provide Human Connection Through Communication
Paradromics3 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2026年3月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Primary Safety: Number of Subjects With Device Related Adverse Events
研究概览
简要总结
The Connect-One Study is an early feasibility study to obtain preliminary device safety information for the Connexus Brain-Computer Interface (BCI). The Connexus BCI is intended to be used as: (1) an assistive communication device to decode imagined language correlates and speech for patients with impaired communication as a result of severe loss of voluntary motor control; and (2) to provide control of computer devices for individuals with severe loss of voluntary motor control of the upper extremity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of a progressive neuromuscular disease or a neurological injury.
- •Clinical diagnosis of anarthria or severe dysarthria.
- •Wheelchair dependent with severely impaired upper limb function.
- •Has a reliable method of communication and the ability to read and understand the English language.
- •Has a study care partner (e.g. caregiver or multiple caregivers) for the duration of the study.
- •Lives within a 4-hour radius of a study site.
排除标准
- •Cognitive impairment or psychiatric illness that could impact the ability to comply with study requirements, as determined by the Study Investigator.
- •Co-morbidities or an ongoing chronic medical condition that would impair the ability to comply with study requirements.
- •The presence of another implanted device, like a pacemaker, deep brain stimulator, or implantable pulse generator.
- •Requires, or is expected to require regular MRI scans for on-going medical conditions.
- •In the opinion of the Study Investigator, the patient is not an appropriate candidate for the study, for reasons that could place the patient at undue risk or otherwise result in non-compliance with the study requirements.
研究组 & 干预措施
Connect-One
Other
干预措施: Connexus Brain-Computer Interface (Device)
结局指标
主要结局
Primary Safety: Number of Subjects With Device Related Adverse Events
时间窗: Up to 12 months post-implant
Device Related Adverse Events: Number of subjects with device-related adverse events
次要结局
- Long-Term Safety: Number of Subjects With Device Related Adverse Events(Up to 6 years post-implant)
研究者
研究点 (3)
Loading locations...
相似试验
招募中
1/2 期
A study evaluating the safety and efficacy of anti-CD19 CAR T in subjects with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma2022-501686-47-00Galapagos, Galapagos25
招募中
1 期
An early Phase 1b Study to assess how safe and effective is the treatment with drugs, called Mosunetuzumab or Glofitamab in Combination with drugs called, CC-220 and CC-99282 in Patients with B-Cell Non-Hodgkin Lymphoma.2023-505185-28-00F. Hoffmann-La Roche AG52
招募中
2 期
Phase 1b Study to Assess the Safety, Tolerability and Pharmacodynamics of PBFT02 in Adult Participants with Frontotemporal Dementia (FTD) and GRN or C9orf72 Mutations2023-507724-23-00Passage Bio Inc.4
撤回
1 期
A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a pDNA Vaccine Candidate Against COVID-19 in Healthy Adults2023-505135-12-00Imam Abdulrahman Bin Faisal University60
招募中
1 期
A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Denikitug (GS-1811), an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With an Anti–PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors2022-501684-40-00Gilead Sciences Inc.93