Health TrialsbyHealthPanel

Functional Outcomes and Control Using Synchron BCI - Canada

ConditionsNeurologic DisorderALSMotor Neuron Disease
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Stentrode

    Device

    The Stentrode is an endovascular electrode array that senses electrical signals from the sensorimotor cortices.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: SingleOther 1 intervention

Trial outcomes

Primary outcomes

1

Device-related serious adverse events resulting in death or permanently increased disability up to 90 days after implant.

Time frame
3 Months

Secondary outcomes

1

Device-related serious adverse events resulting in death or permanently increased disability up to 1 year after implant.

Time frame
12 Months
2

Target vessel patency assessed using CT venography at 90 and 365 days after implant.

Time frame
3 Months and 12 Months
3

Device migration assessed using CT venography at 90 and 365 days after implant.

Time frame
3 Months and 12 Months

Other outcomes

1

Time in days from implant to device activation.

Time frame
Number of days from device implant to device activation, up to 12 months after implant.
2

Stability of recorded BCI signal, using monthly measurements up to 1 year after device implant.

Time frame
12 Months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Synchron, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now