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SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

Primary Purpose

Neurologic Disorder, Paralysis, Paralysis; Stroke

Status
Withdrawn
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Motor Neuroprosthesis
Sponsored by
Synchron Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurologic Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Sydney Local Health District
  • Metro North Health
  • Melbourne Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single

Arm Description

Implantation of motor neuroprosthesis medical device.

Outcomes

Primary Outcome Measures

Treatment related adverse events

Secondary Outcome Measures

Full Information

First Posted
September 1, 2021
Last Updated
March 17, 2023
Sponsor
Synchron Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05041114
Brief Title
SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study moved to U.S.
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synchron Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurologic Disorder, Paralysis, Paralysis; Stroke, Amyotrophic Lateral Sclerosis, Muscular Dystrophies, Spinal Cord Injury, Stroke, Lacunar, Stroke, Brainstem, Upper Limb Injury, Spinal Muscular Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single
Arm Type
Other
Arm Description
Implantation of motor neuroprosthesis medical device.
Intervention Type
Device
Intervention Name(s)
Motor Neuroprosthesis
Intervention Description
Type of implantable brain computer interface
Primary Outcome Measure Information:
Title
Treatment related adverse events
Time Frame
12 months post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe motor impairment Able to give consent Appropriate candidate for neurointerventional procedure Able and willing to access all clinical testing and not impeded by geographical location Proficient in English Have a study partner Exclusion Criteria: Active condition resulting in immunosuppression Unsuitable for general anaesthetic Anaphylactic allergy to contrast media Allergy to nickel History of pulmonary embolism History of recent deep vein thrombosis Psychiatric or psychological disorder No study partner or caregiver Unable to provide evidence of COVID vaccination
Facility Information:
Facility Name
Sydney Local Health District
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Metro North Health
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Melbourne Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

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