Functional Outcomes and Control Using Synchron BCI - Canada
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSynchron, Inc.
About this trial
Functional Outcomes and Control Using Synchron BCI - Canada (FOCUS-CAN)
Eligibility criteria
Qualifiers
Able to provide informed consent to participate in the study, in the opinion of the Investigator(s).
Diagnosis of amyotrophic lateral sclerosis or motor neuron disease, with bilateral upper-limb paresis.
Aged 18 years or older.
Life expectancy greater than 12 months post-implantation, in the opinion of the Investigator(s).
Disqualifiers
Unrealistic expectations regarding the potential benefits of the device, in the opinion of the Investigator(s).
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 (e.g., severe depression, psychotic features, personality disorder, severe emotional lability, substance abuse), in the opinion of the Investigator(s).
Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities, in the opinion of the Investigator(s).
Trial design
Treatments tested in this trial
- Stentrode
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
2Sunnybrook Health Sciences CentreM5C 1N2, TorontoOntario, Canada
St. Michael's HospitalM5C 1R6, Toronto Canada
Sponsors and collaborators
Synchron, Inc.
Lead sponsor
Source ClinicalTrials.gov