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Neurologic DisorderNCT03834857

SWITCH: Stentrode First-in-Human Study of Implantable BCI for Control of a Digital Device

A study testing Stentrode in people with Neurologic Disorder, run by Synchron Australia Pty Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

SWITCH Study Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neurologic Disorder
What is being tested?
Stentrode
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteAustralia
Study dates
27 May 2019to 9 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of spinal cord injury (SCI), motor neurone disease (MND) [also known as amyotrophic lateral sclerosis (ALS)], stroke, muscular dystrophy or loss of limbs.
  • Diagnosed for at least six (6) months and if SCI, at least twelve (12) months
  • Aged between 18 and 75 years of age; females must be of non-child bearing potential or with negative pregnancy test and not breast feeding
  • Life expectancy of at least twelve (12) months in the opinion of the treating physician
  • Understands English
  • Is computer literate
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  • Is willing and able to access all clinical testing locations and is not impeded by geographical location (ie: ideally lives within 100 kms or Less than 2 hours travel time to study site)
  • No conditions, including an eye movement disorder, that would prevent the use of eye tracking software and has a level of vision that will not impede viewing of screens and visualisations
  • Has normal venous sinus anatomy, with two patent jugular veins (of sufficient size for the device) and bilateral patent transverse sinuses as evidenced by MR venography (MRV) or CT venography (CTV) within the last six (6) months or if vascular anatomy is unknown, is willing to undergo an MRV or CTV assessment to assess vascular suitability for endovascular device placement
  • Evidence of activation, under fMRI testing, of motor cortical areas adjacent to the superior sagittal sinus

Who cannot join

  • Is unwilling to comply with all procedures relating to study
  • Based on the doctors opinion, has unrealistic expectations regarding the possible benefits, risks and limitations associated with the implantation or surgical procedures
  • Has dementia or cognitive impairment sufficient to impair capacity to provide informed consent or which could impact ability to comply with investigational requirements (eg: MMSE <24, ECAS or other determination made by Investigator)
  • For MND participants, has NOT had a formal capacity assessment by a professional with experience in capacity assessment (psychiatrist, neurologist, psychologist) within 90 days of Screen1 visit, which assesses capacity to consent and excludes Frontotemporal dementia
  • Has a history of substance abuse within the preceding two (2) years
  • Chronic oral or intravenous steroids or immunosuppressive therapy or other therapy/clinical condition that severely reduces immunity Has been hospitalized for a psychiatric condition with the preceding two (2) years or has had a history of psychosis within the preceding two (2) years
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  • Has a contraindication to magnetic resonance imaging (MRI)
  • Has an active implanted stimulation device (eg: pacemaker, deep brain stimulator, spinal cord stimulator)
  • Is deemed unsuitable by a specialist anaesthesiologist or respiratory physician to undergo a general anaesthetic
  • Has findings on MRV deemed incompatible, by an experienced neurointerventionalist, with device implantation in the SSS [eg: isolated dominant, superior anastomotic vein (vein of Trolard)]
  • Has a contraindication to angiographic imaging, including chronic kidney injury (CKI -eGFR < 60mls/min)
  • Has known allergy to contrast media
  • Has any bleeding disorders (tests required if clinical status unknown) or is resistant to aspirin and/or clopidogrel or has any contraindication that precludes antithrombotic treatment
  • Has an allergy to any materials included in the implanted device
  • Has a history of Deep Vein Thrombosis (DVT) or on hormone therapy (eg: HRT)
  • Any serious disease or disorder that in the opinion of the Investigator, could seriously affect ability to participate in the study
  • Does not have a family member/caregiver (or equivalent) who can be present during the consent process and support all study visits
  • Has had any of the following neuropathologies;
  • Sinus Thrombosis
  • Venous Hypertension
  • Hydrocephalus
  • Bleeding Disorders

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3050

Other trials in Australia

About this study

Official title: Stentrode With Thought-controlled Digital Switch: An Early Feasibility Study (EFS) of the Safety of the Stentrode Device in Participants With Loss of Motor Function Due to Paralysis

SWITCH Study

Read the detailed description

STENTRODE WITH THOUGHT CONTROLLED DIGITAL SWITCH: An early feasibility study (EFS) of the safety of the StentrodeTM device in participants with loss of motor function due to paralysis from spinal cord injury, motor neuron disease, stroke, muscular dystrophy or loss of limbs.

Research has shown that in individuals with neurological conditions, brain signals can be recorded using electrical sensors implanted on to the brain. These signals could be used by the individuals to control assistive technology (e.g. spelling devices) that help with daily life, just by thinking. However, implanting these electrical sensors often requires open brain surgery.

A new medical device and surgical technique has been developed, which allows implantation of the electrical sensors without open brain surgery. The device, called Stentrode™, is a small metallic mesh tube (stent), with electrode contacts (small metal disks) within the stent structure. It can be placed inside a blood vessel of the brain located in the motor cortex. This does not involve open brain surgery.

The purpose of this research is to evaluate the safety of the Stentrode™ device in humans. This is an experimental device. This research will be the first of its kind to be performed in humans and may help find safer, more effective ways to introduce/implant electrical sensors in patients. This could foster the development of user friendly biotechnology for patients with neurological conditions.

Being tested
Stentrode
Medical subject headings
Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StentrodeDevice

    Implantation of Stentrode device

Study groups in NCT03834857
Study groupRoleWhat they receive
singleOtherImplantation of Stentrode device
Receives: Device: Stentrode

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-Related Adverse Events

    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    Measured: 12 month post implant

Secondary outcomes (1)

  1. High fidelity and stable signals over 12 months

    1. The mean and standard deviation (SD) of first three measurements of impedance values across all 16 channels, excluding flag values, to a maximum of 10 measurements
    2. The mean and SD of noise floor calculated from 2 mins of baseline recording
    3. The mean and SD of signal-to-noise ratio across 3 mins recording of photic stimulation

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2019
  2. Study start27 May 2019
  3. Primary completion10 Dec 2021
  4. Study completion9 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Insertion of Stentrode TM device
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03834857
Sponsor's protocol ID
S-01-01
Status last verified
Aug 2022
First submitted
1 Feb 2019
Last updated
1 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kacker K, Chetty N, Feldman AK, Bennett J, Yoo PE, Fry A, Lacomis D, Harel NY, Nogueira RG, Majidi S, Opie NL, Collinger JL, Oxley TJ, Putrino DF, Weber DJ. Motor activity in gamma and high gamma bands recorded with a Stentrode from the human motor cortex in two people with ALS. J Neural Eng. 2025 Mar 31;22(2):026036. doi: 10.1088/1741-2552/adbd78.

    PubMed 40048825

  • Mitchell P, Lee SCM, Yoo PE, Morokoff A, Sharma RP, Williams DL, MacIsaac C, Howard ME, Irving L, Vrljic I, Williams C, Bush S, Balabanski AH, Drummond KJ, Desmond P, Weber D, Denison T, Mathers S, O'Brien TJ, Mocco J, Grayden DB, Liebeskind DS, Opie NL, Oxley TJ, Campbell BCV. Assessment of Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis in 4 Patients: The Stentrode With Thought-Controlled Digital Switch (SWITCH) Study. JAMA Neurol. 2023 Mar 1;80(3):270-278. doi: 10.1001/jamaneurol.2022.4847.

    PubMed 36622685

Questions about this trial

What is this clinical trial studying?

A study testing Stentrode in people with Neurologic Disorder, run by Synchron Australia Pty Ltd. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-Related Adverse Events (time frame: 12 month post implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03834857, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.

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