Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620536
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Restoring Hand Function in Patients with Tetraplegia by Intraneural Stimulation of Peripheral Nerves
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Restoring Hand Function in Patients with Tetraplegia by Intraneural Stimulation of Peripheral Nerves
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REGRASP
Brief Summary:
The aim of the clinical investigation is to evaluate the feasibility in terms of efficacy and safety of a prosthetic system the Regrasp 1 system based on intraneural stimulation via TIME- 4H electrodes as an aid device for restoring hand function in tetraplegic patients
Detailed Description:
The study involves implanting intraneural electrodes in the nerve used to open and close the hand
Electrical stimulation will activate the forearm and hand muscles and thus evoke movements such as opening and closing the fingers of the hand and wrist movements Electrodes will be implanted temporarily and reversibly within the fascicles so that a more selective and therefore more effective stimulation can be determined The electrodes will remain implanted for about 6 months
During this period the results of the external electrical stimulation will be analysed through experimental sessions that will take place at the Careggi University Hospital At the end of the study the electrodes will be removed by surgery under general anaesthesia
Electrical stimulation will activate the forearm and hand muscles and thus evoke movements such as opening and closing the fingers of the hand and wrist movements Electrodes will be implanted temporarily and reversibly within the fascicles so that a more selective and therefore more effective stimulation can be determined The electrodes will remain implanted for about 6 months
During this period the results of the external electrical stimulation will be analysed through experimental sessions that will take place at the Careggi University Hospital At the end of the study the electrodes will be removed by surgery under general anaesthesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None