M. Genioglossus (GG) response to electrical stimulation of the internal branch of the Superior Laryngeal Nerve (iSLN)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 7
Study Overview
Brief Summary
The results of the 6 patients compatible with PP analysis showed that the iSLN electrostimulation is able to generate at least an ipsilateral GG response, i.e., to increase the activity of this muscle. In general, it was observed that the time interval between stimulation bursts and the current intensity of the stimuli contribute to the generation of the respective EMG activity. The patients who where mechanically ventilated did not show this inspiratory related activity, but tonic EMG activity elicited by iSLN stimulation. Switching from mechanical ventilation to spontaneous respiration led to an increase in tonic GG_I activity, which further increased during one stimulation burst. In this case, the increased tonic GG_I activity persisted but but did not further increase following several stimulation bursts. The experimental setting and the great inter-patient variability prevented the collection of poolable data.
Study Design
- Study Type
- Interventional
- Allocation
- N/a: Single Arm Study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •Age = 18 years
- •Patients who, independently from the enrollment in this clinical investigation, are pre-scheduled for an ENT surgery (such as laryngectomies or neck dissections) for which the iSLN exposure is foreseen and for whom, as a consequence of the said pre-scheduled ENT surgery the post-operative functionality of the exposed iSLN is irrelevant
- •Anatomic, physiological and mental conditions compatible with the participation in this clinical investigation
- •Signed and dated informed consent before the start of any clinical investigation-specific procedure for all the recruited subjects
Exclusion Criteria
- •Lack of compliance with any inclusion criteria
- •Pregnant or breast-feeding women
- •Other clinical diseases that might result in alteration of the outcomes of this clinical investigation (e.g. other types of dystonia, tremors, etc.)
- •Use of an active medical implant
- •Known allergies or intolerance to the material used for this clinical investigation
- •Parallel participation in a device/drug clinical investigation in the period of data collec-tion, which could confound the results of the clinical investigation 2019CIP001
- •Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation