Functional Outcomes and Control Using Synchron BCI - Australia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorSynchron, Inc.

About this trial

Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)

Eligibility criteria

Qualifiers

Able to provide informed consent to participate in the study.

Bilateral upper-limb paresis or Amyotrophic lateral sclerosis (ALS) with bilateral upper limb paresis

The underlying condition causing motor impairment must be refractory to treatment and have been present for a minimum of twelve months.

Aged 21 years or older

Disqualifiers

Unrealistic expectations regarding the potential benefits of the device.

Active infection or unexplained fever in the 48 hours prior to informed consent

Major psychiatric disorder that may adversely impact the participant's safety or study compliance, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse.

Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities.

Trial design

Treatments tested in this trial

  • Stentrode

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators