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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03834857




Registration number
NCT03834857
Ethics application status
Date submitted
1/02/2019
Date registered
8/02/2019
Date last updated
1/09/2022

Titles & IDs
Public title
SWITCH: Stentrode First-in-Human Study of Implantable BCI for Control of a Digital Device
Scientific 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
Secondary ID [1] 0 0
S-01-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurologic Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Stentrode

Other: single - Implantation of Stentrode device


Treatment: Devices: Stentrode
Implantation of Stentrode device
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment-Related Adverse Events
Timepoint [1] 0 0
12 month post implant
Secondary outcome [1] 0 0
High fidelity and stable signals over 12 months
Timepoint [1] 0 0
36 months

Eligibility
Key inclusion criteria
1. 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.
2. Diagnosed for at least six (6) months and if SCI, at least twelve (12) months
3. 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
4. Life expectancy of at least twelve (12) months in the opinion of the treating physician
5. Understands English
6. Is computer literate
7. 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)
8. 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
9. 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
10. Evidence of activation, under fMRI testing, of motor cortical areas adjacent to the superior sagittal sinus
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Is unwilling to comply with all procedures relating to study
2. Based on the doctors opinion, has unrealistic expectations regarding the possible benefits, risks and limitations associated with the implantation or surgical procedures
3. 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)
4. 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
5. Has a history of substance abuse within the preceding two (2) years
6. 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
7. Has a contraindication to magnetic resonance imaging (MRI)
8. Has an active implanted stimulation device (eg: pacemaker, deep brain stimulator, spinal cord stimulator)
9. Is deemed unsuitable by a specialist anaesthesiologist or respiratory physician to undergo a general anaesthetic
10. 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)]
11. Has a contraindication to angiographic imaging, including chronic kidney injury (CKI -eGFR < 60mls/min)
12. Has known allergy to contrast media
13. 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
14. Has an allergy to any materials included in the implanted device
15. Has a history of Deep Vein Thrombosis (DVT) or on hormone therapy (eg: HRT)
16. Any serious disease or disorder that in the opinion of the Investigator, could seriously affect ability to participate in the study
17. Does not have a family member/caregiver (or equivalent) who can be present during the consent process and support all study visits
18. Has had any of the following neuropathologies;

1. Sinus Thrombosis
2. Venous Hypertension
3. Hydrocephalus
4. Bleeding Disorders

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/01/2022
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Synchron Australia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
SWITCH Study
Trial website
https://clinicaltrials.gov/study/NCT03834857
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Oxley
Address 0 0
University of Melbourne and Synchron
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03834857