|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03496025 |
|
Date of registration:
|
19/03/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Facial Function Reanimation by Electrical Pacing in Unilateral Facial Paralysis.
|
|
Scientific title:
|
Mimetic Interfaces - Toispuoleisen Kasvohermohalvauksen Kojeellinen Kuntoutus Terveen Puolen Lihasaktiviteettiohjauksella. Stimulaattorin Prototyypin Testaus terveillä koehenkilöillä ja Kasvohermohalvauspotilailla. |
|
Date of first enrolment:
|
August 1, 2015 |
|
Target sample size:
|
77 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03496025 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
Finland
| | | | | | | |
|
Contacts
|
|
Name:
|
Markus Rautiainen, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
professor, head physician |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- a unilateral peripheral facial nerve palsy (patients)
- willingness to participate (patients, healthy volunteers)
Exclusion Criteria:
- malignant diseases (a previously treated cancer is not an exclusion criterion)
- unstable cardiovascular disease
- severe immune deficiency
- other severe neurological diseases (causing cognitive or physical impairment)
- diabetic neuropathy
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Facial Nerve Palsy
|
|
Intervention(s)
|
|
Device: Electrical muscle stimulation
|
|
Primary Outcome(s)
|
|
Amplitudee of the movement elicited by electrical stimulation
[Time Frame: Immediate]
|
|
Secondary Outcome(s)
|
|
Subjective ratings related to the tolerability of stimulations
[Time Frame: Immediate]
|
|
Subjective ratings related to acceptability of the stimulated movement
[Time Frame: Immediate]
|
|
Changes in lacrimal fluid
[Time Frame: Immediate]
|
|
Visual acuity
[Time Frame: Immediate]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|