Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05041114




Registration number
NCT05041114
Ethics application status
Date submitted
1/09/2021
Date registered
10/09/2021
Date last updated
21/03/2023

Titles & IDs
Public title
SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
Scientific title
Stentrode With Thought-controlled Digital Switch: An Early Feasibility Study of the Safety of an Endovascular Motor Neuroprosthesis in Participants With Severe Upper Limb Impairment.
Secondary ID [1] 0 0
S-01-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurologic Disorder 0 0
Paralysis 0 0
Paralysis; Stroke 0 0
Amyotrophic Lateral Sclerosis 0 0
Muscular Dystrophies 0 0
Spinal Cord Injury 0 0
Stroke, Lacunar 0 0
Stroke, Brainstem 0 0
Upper Limb Injury 0 0
Spinal Muscular Atrophy 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Injuries and Accidents 0 0 0 0
Fractures
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Neurological 0 0 0 0
Neurodegenerative diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Skin 0 0 0 0
Other skin conditions

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

Other: Single - Implantation of motor neuroprosthesis medical device.


Treatment: Devices: Motor Neuroprosthesis
Type of implantable brain computer interface
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 months post implant

Eligibility
Key inclusion criteria
1. Severe motor impairment

2. Able to give consent

3. Appropriate candidate for neurointerventional procedure

4. Able and willing to access all clinical testing and not impeded by geographical
location

5. Proficient in English

6. Have a study partner
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active condition resulting in immunosuppression

2. Unsuitable for general anaesthetic

3. Anaphylactic allergy to contrast media

4. Allergy to nickel

5. History of pulmonary embolism

6. History of recent deep vein thrombosis

7. Psychiatric or psychological disorder

8. No study partner or caregiver

9. Unable to provide evidence of COVID vaccination

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2022
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Sydney Local Health District - Sydney
Recruitment hospital [2] 0 0
Metro North Health - Brisbane
Recruitment hospital [3] 0 0
Melbourne Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 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
The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor
impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning
motor cortex. The purpose of this research is to evaluate safety and feasibility.

The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor
neurons. The device is designed to restore the transmission of neural signal from the
cerebral cortex utilized for neuromuscular control of digital devices, resulting in a
successful execution of non-mechanical digital commands.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05041114
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/ct2/show/NCT05041114