ClinicalTrials.gg
WithdrawnNCT05041114Updated Mar 21, 2023

SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

An interventional study of Motor Neuroprosthesis in Neurologic Disorder, Paralysis and Paralysis; Stroke, sponsored by Synchron Medical, Inc.. Withdrawn at 3 sites in Australia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-21.

Sponsored by Synchron Medical, Inc. · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Study moved to U.S.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility.

The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.

02

Conditions studied

  • Neurologic Disorder
  • Paralysis
  • Paralysis; Stroke
  • Amyotrophic Lateral Sclerosis
  • Muscular Dystrophies
  • Spinal Cord Injury
  • Stroke, Lacunar
  • Stroke, Brainstem
  • Upper Limb Injury
  • Spinal Muscular Atrophy
03

In context

Nervous System Diseases

757 studies on the registry are indexed under Nervous System Diseases; 218 are open to participants now.

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Lead sponsor

Synchron Medical, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Severe motor impairment
  2. Able to give consent
  3. Appropriate candidate for neurointerventional procedure
  4. Able and willing to access all clinical testing and not impeded by geographical location
  5. Proficient in English
  6. Have a study partner

Exclusion criteria

Exclusion Criteria:

  1. Active condition resulting in
  2. Unsuitable for general anaesthetic
  3. Anaphylactic allergy to contrast media
  4. Allergy to nickel
  5. History of pulmonary embolism
  6. History of recent deep vein thrombosis
  7. Psychiatric or psychological disorder
  8. No study partner or caregiver
  9. Unable to provide evidence of COVID vaccination
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Single

    Implantation of motor neuroprosthesis medical device.

    Device: Motor Neuroprosthesis

Interventions

  • DeviceMotor Neuroprosthesis

    Type of implantable brain computer interface

06

What researchers measure

Primary outcomes

  1. Treatment related adverse events

    Time frame: 12 months post implant

07

Study locations

3 sites
  • Sydney Local Health District
    Sydney, New South Wales, Australia
  • Metro North Health
    Brisbane, Queensland, Australia
  • Melbourne Health
    Melbourne, Victoria 3050, Australia
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Nov 2022, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2021
First posted
Sep 10, 2021
StartActual
Apr 21, 2022
Primary completionActual
Nov 30, 2022
CompletionActual
Nov 30, 2022
Last update
Mar 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05041114
Lead sponsor
Synchron Medical, Inc.
Responsible party
Sponsor
First posted
Sep 10, 2021
Start date
Apr 21, 2022
Primary completion
Nov 30, 2022
Completion
Nov 30, 2022
Last update
Mar 21, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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