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

NCT03834857 | Completed DMC

• 1 other identifier: S-01-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

SWITCH Study

Conditions

Neurologic Disorder

Outcome Measures

Primary Outcomes (1)

• Treatment-Related Adverse Events

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

  12 month post implant

Secondary Outcomes (1)

• High fidelity and stable signals over 12 months

  36 months

Study Arms (1)

single

OTHER

Implantation of Stentrode device

Device: Stentrode

Interventions

Stentrode DEVICE

Implantation of Stentrode device

single

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Synchron Australia Pty Ltd.: lead

Study Sites (1)

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Related Publications (1)

• 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.

  PMID: 36622685 DERIVED

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Thomas Oxley

  University of Melbourne and Synchron

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Insertion of Stentrode TM device

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 8, 2019
• Study Start: May 27, 2019
• Primary Completion: December 10, 2021
• Study Completion: January 9, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

AU (1)