Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343285
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-01-26
Brief Title:
Upper Limb Tremor Reduction in Essential Tremor Patients
Sponsor:
Encora Inc
Organization:
Encora Inc
Study Overview
Official Title:
Upper Limb Tremor Reduction in Essential Tremor Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
ULTRE
Brief Summary:
This study is designed to demonstrate the safety and tolerability of the Encora Therapeutics Tremor Mitigation Device in subjects with upper limb tremor caused by Essential Tremor
Detailed Description:
A prospective randomized blinded clinical trial Subjects meeting all inclusion criteria will have five days of treatment with each of the three arms received in a randomized order Subjects will complete two rounds of assessments each day
Arm 1 Inactive stim Arm 2 Stim therapy utilizing a specific dermatome Arm 3 Stim therapy utilizing a tailored frequency
Arm 1 Inactive stim Arm 2 Stim therapy utilizing a specific dermatome Arm 3 Stim therapy utilizing a tailored frequency
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None