FDA批准Paradromics的脑计算机接口试验 以恢复严重受损病人的言语能力 FDA approves Paradromics' brain-computer interface trial to restore speech in severely impaired patients.

Paradromics已获得FDA批准，开展其脑机接口Connexus的长期临床试验，用于恢复严重运动障碍患者的语言能力。 Paradromics has received FDA approval for a long-term clinical trial of its brain-computer interface, the Connexus, to restore speech in people with severe motor impairments. 该植入器是一个有421个微电线电极的硬币大小装置,记录了运动皮层的神经活动,以便用用户自己的声音将想象中的言词转换成文字或合成语音输出。 The implant, a dime-sized device with 421 microwire electrodes, records neural activity from the motor cortex to translate imagined speech into text or synthetic voice output using the user’s own voice. 明年年初开始的试验首先将涉及两名参加者,评估安全、通信速度以及控制计算机光标的能力。 The trial, starting early next year, will initially involve two participants and assess safety, communication speed, and the ability to control a computer cursor. 该系统在动物试验中显示高数据传输率,有可能提供比其他BCI更快的通信。 The system has shown high data transmission rates in animal tests, potentially offering faster communication than other BCIs. 如果成功,试验可扩大到最多10名有双重植入的参与者。 If successful, the trial may expand to up to ten participants with dual implants.