Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT03834857
Eligibility Criteria:
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
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03834857
Study Brief:
Protocol Section:
NCT03834857