bRain-triggered Electrical stimulAtioN for Inducing Muscle Activation in individuals wiTh sEvere facial paralysis (REANIMATE)

bRain-triggered Electrical stimulAtioN for Inducing Muscle Activation in individuals wiTh sEvere facial paralysis (REANIMATE) - REANIMATE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56911

Enrollment

Registered

2024-07-31

Start date

2024-05-01

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

n/a

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Experiment I with healthy volunteers: • Age 18 years and higher Experiment II with patient participants: • Age 18 years and higher • A clinical indication for undergoing a surgery, such as a brainstem stroke or a neurovascular conflict Survey study with healthy volunteers: • Age 18 years and higher

Exclusion criteria

Exclusion criteria: Experiment I with healthy volunteers: • A history of electrical stimulation on the face for clinical reasons • Impairment in facial muscle movement Experiment II with patient participants: • Indication of longer than average (6 hours for brainstem surgery and 4 hours for neurovascular conflict surgery) duration of the procedure (estimation by the neurosurgeon). • The neurosurgeon or neurophysiologist decides that a certain patient is not eligible to participate in the study (e.g., for medical or surgical reasons). • Reported function loss that prohibits the accurate performance of the required tasks. Survey study with healthy volunteers: • Participation in Experiment I.

Design outcomes

Primary

Measure	Time frame
The main study parameter is the accuracy of FES-induced facial expressions. The accuracy will be accessed using a number of different measurements and analyses, including 1) manual and computer-based analysis of video recordings of subjects* facial movements during FES; 2) self-reported perceptual feedback of subjects regarding what facial expression was induced and their certainty estimates about it; 3) ratings of recognizability of FES-induced facial expressions in processed video recordings by external observers; 4) whenever possible, electromyography recordings tracking individual facial muscle movements during FES application.	—

Measure

Time frame

The main study parameter is the accuracy of FES-induced facial expressions. The accuracy will be accessed using a number of different measurements and analyses, including 1) manual and computer-based analysis of video recordings of subjects* facial movements during FES; 2) self-reported perceptual feedback of subjects regarding what facial expression was induced and their certainty estimates about it; 3) ratings of recognizability of FES-induced facial expressions in processed video recordings by external observers; 4) whenever possible, electromyography recordings tracking individual facial muscle movements during FES application.

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Secondary

Measure	Time frame
The secondary study parameters or endpoints consist of stimulation parameters, effects of inter-subject variability and the relationship between individual facial muscles and wholistic facial expressions.	—

Countries

Netherlands

Outcome results