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STENTRODE First in Human Early Feasibility Study (SWITCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834857
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Synchron Medical, Inc

Tracking Information
First Submitted Date  ICMJE February 1, 2019
First Posted Date  ICMJE February 8, 2019
Last Update Posted Date April 4, 2019
Estimated Study Start Date  ICMJE June 15, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
Treatment-Related Adverse Events [ Time Frame: 12 month post implant ]
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
High fidelity and stable signals over 12 months [ Time Frame: 36 months ]
  1. 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
  2. The mean and SD of noise floor calculated from 2 mins of baseline recording
  3. The mean and SD of signal-to-noise ratio across 3 mins recording of photic stimulation
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
Performance Assessment [ Time Frame: 36 months ]
Impedance measurements, Switch activation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STENTRODE First in Human Early Feasibility Study
Official Title  ICMJE 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
Brief Summary SWITCH Study
Detailed Description

STENTRODE WITH THOUGHT CONTROLLED DIGITAL SWITCH: An early feasibility study (EFS) of the safety of the StentrodeTM 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.

Research has shown that in individuals with neurological conditions, brain signals can be recorded using electrical sensors implanted on to the brain. These signals could be used by the individuals to control assistive technology (e.g. spelling devices) that help with daily life, just by thinking. However, implanting these electrical sensors often requires open brain surgery.

A new medical device and surgical technique has been developed, which allows implantation of the electrical sensors without open brain surgery. The device, called Stentrode™, is a small metallic mesh tube (stent), with electrode contacts (small metal disks) within the stent structure. It can be placed inside a blood vessel of the brain located in the motor cortex. This does not involve open brain surgery.

The purpose of this research is to evaluate the safety of the Stentrode™ device in humans. This is an experimental device. This research will be the first of its kind to be performed in humans and may help find safer, more effective ways to introduce/implant electrical sensors in patients. This could foster the development of user friendly biotechnology for patients with neurological conditions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Insertion of Stentrode TM device
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Neurologic Disorder
Intervention  ICMJE Device: StentrodeTM
Implantation of Stentrode TM device
Study Arms  ICMJE single
Implantation of Stentrode TM device
Intervention: Device: StentrodeTM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2019)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christin Bird +6139342 7572 christin.bird@mh.org.au
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03834857
Other Study ID Numbers  ICMJE S-01-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Synchron Medical, Inc
Study Sponsor  ICMJE Synchron Medical, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thomas Oxley Sponsor GmbH
PRS Account Synchron Medical, Inc
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP