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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03834857
Ethics application status
Date submitted
1/02/2019
Date registered
8/02/2019
Date last updated
4/04/2019

Titles & IDs
Public title
STENTRODE First in Human Early Feasibility Study
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 From Spinal Cord Injury, Motor Neuron Disease, Stroke, Muscular Dystrophy or Loss of Limbs
Secondary ID [1] 0 0
S-01-01
Universal Trial Number (UTN)
Trial acronym
SWITCH
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 - StentrodeTM

Other: single - Implantation of Stentrode TM device


Treatment: Devices: StentrodeTM
Implantation of Stentrode TM device

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment-Related Adverse Events - Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Timepoint [1] 0 0
12 month post implant
Secondary outcome [1] 0 0
High fidelity and stable signals over 12 months - 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
The mean and SD of noise floor calculated from 2 mins of baseline recording
The mean and SD of signal-to-noise ratio across 3 mins recording of photic stimulation
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
Gender
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
Device Feasibility
Allocation to intervention
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Health - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Synchron Medical, Inc
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Thomas Oxley
Address 0 0
Sponsor GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Christin Bird
Address 0 0
Country 0 0
Phone 0 0
+6139342 7572
Fax 0 0
Email 0 0
christin.bird@mh.org.au
Contact person for scientific queries

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