Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-17 @ 3:38 AM
Study NCT ID:
NCT02878720
Status:
UNKNOWN
Last Update Posted:
2020-01-27
First Post:
2016-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients
Sponsor:
Campus Bio-Medico University
Organization:
Study Overview
Official Title:
Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Previous studies suggested that both robot-assisted rehabilitation and non-invasive vagus nerve stimulation can improve upper limb function in chronic stroke patients. Aim of present study is to explore whether the combination of these two approaches might enhance their positive effects on motor recovery. Safety and efficacy of this combination will be assessed within a proof-of-principle, double-blinded, randomized, sham-controlled trial. Transcutaneous vagus nerve stimulation (tVNS) will be delivered at left ear, in order to improve the response to the following robot-assisted therapy. Patients with both ischemic and hemorrhagic chronic stroke will be randomized to robot-assisted therapy associated with real or sham tVNS, delivered for 10 working days. Change in Fugl-Meyer has been chosen as primary outcome, while changes in several quantitative indicators of motor performance extracted by the robot as secondary outcomes.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: