No registrations found.
Source
Brief title
Health condition
multiple sclerosis, dysphagia, swallowing disorders, NMES
multiple sclerose, dysfagie, slikproblemen, NMES
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
A protocol to determine optimal electrode placement and neuromuscular electrical stimulation parameters for NMES for
dysphagia in individual MS patients.
Secondary outcome
The variability in location and type of motor dysfunctions of hyoid muscles in patients with MS visualized with
ultrasonography.
Background summary
This study will allow the investigation of the optimal parameters of neuromuscular electrical stimulation (NMES) in MS patients. We aim to develop a protocol for NMES to determine optimal electrode placement and stimulation parameters in dysphagia MS patients. The use of NMES as treatment may prevent complications and may increase Quality of Life in MS patients with dysphagia.
Study objective
The reported incidence of dysphagia in multiple sclerosis (MS) varies between 33% and 90% and is higher in more disabled patients. Dysphagia is associated with an increased risk of aspiration pneumonia, increase in health-care cost and increase in mortality and a decrease of quality of life (QOL). Patients with oropharyngeal swallowing problems are commonly referred to a speech-therapist for further assessment and treatment.
Limited evidence is available for treatment of dysphagia in MS. A significant decrease of dysphagia in MS after treatment with neuromuscular electrical stimulation (NMES) was found, but in other studies the results of the effect of NMES on dysphagia were inconsistent. Therefore, the need for research into the optimal parameters for the application of NMES is clear.
Study design
One timepoint of measurement: ultrasonography and NMES will be used at the same day in approximately 1 hour.
Intervention
Ultrasonography will be used to determine the location and
assess the morphology of the hyoid muscles.
Electrical stimulation will be used to stimulate the hyoid muscles.
Simultaneously, ultrasonography will be used to guide optimal electrode placement and stimulation characteristics.
Leonie Ruhaak
[default] 2042XK
The Netherlands
+31204440763
l.ruhaak@amsterdamumc.nl
Leonie Ruhaak
[default] 2042XK
The Netherlands
+31204440763
l.ruhaak@amsterdamumc.nl
Inclusion criteria
- > 18 years of age
- confirmed diagnosis of MS
- dysphagia characterized by incomplete hyoid movement
Exclusion criteria
- other neurological disorders
- obstruction of nasal passage
- significant cognitive deficits (has to be able to follow instructions during endoscopy and give feedback on sensing stimulation or pain in head and neck
- medically not stable enought to participate in endoscopy
- radiotherapy or oncology in head/neck area
- in case of heart problems, metal implants in head/neck area, inflamed skin, implanted stimulators or electronic devices, participation should be evaluated by a medical doctor
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7182 |
NTR-old | NTR7373 |
CCMO | NL62007.029.17, 2017.532, 16-948 MS |