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Trial from ClinicalTrials.gov

STENTRODE First in Human Early Feasibility Study

  • Recruitment status at the time of last update
    Recruiting
  • Has the trial been updated in the last 24 months?
    Up to date
    (Last updated: 2/4/2019)
Key trial Information

Trial ID

NCT03834857

Date registered

06 February 2019

Recruitment status

Recruiting

Anticipated date of first participant enrolment

15 June 2019

Brief summary

SWITCH Study

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

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