Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05224973 |
| Other study ID # |
21-PP-14 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 23, 2022 |
| Est. completion date |
March 23, 2025 |
Study information
| Verified date |
June 2023 |
| Source |
Centre Hospitalier Universitaire de Nice |
| Contact |
Guillaume SACCO, MD |
| Phone |
04 92 03 47 51 |
| Email |
sacco.g[@]chu-nice.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Swallowing disorders are a common consequence of stroke. After stroke, some patients retain a
dysphagia responsible for an alteration of the quality of life, respiratory diseases and a
degradation of the general health status.
The oral phase of the swallowing involves a significant control of the various intraoral
organs. These allow the formation of the bolus, its propulsion, and the emptying of the oral
cavity after swallowing. Precise and coordinated mobility of the tongue, lips and mandible is
essential during this time. During the speech therapy after a stroke, targeted analytical
training, coupled with passive stimulations of the swallowing reflex, is typically used.
Previous studies have shown a functional link between fine manual motor skills and oral motor
skills, particularly during child development. Little data are available for adult subjects.
A pilot study is therefore needed before a larger scale comparative study can be considered.
Our hypothesis is that there is a functional link between digital and oral motor areas that
could, through co-activation during rehabilitation sessions, promote the recovery of
swallowing disorders after stroke.
Description:
Around the world, in 2012, 5 million people were estimated to survive a stroke with permanent
disabilities. About half of stroke victims suffer from dysphagia during the acute phase and
almost a fifth of them still show clinical signs beyond 14 days. These disorders may persist
in some patients after six months and are not spontaneously resolved. In the case of
Wallenberg syndrome, for example, there is anaesthesia of the face, a fall of the veil of the
palate, a hypotonia of half the tongue. In the other clinical tables, deficits vary according
to the territories affected. Thus we distinguish the dysphagia of type bulbar paresis from
that of type pseudo-bulbar paresis. If the former still includes severe symptoms such as
complete loss or weakening of the swallowing reflex, the second is marked by the weakness of
contraction of the muscles involved in swallowing and the coordination deficits of these
voluntary movements. Right hemispheric involvement would be characterized by delayed onset of
pharyngeal time and a greater incidence of laryngeal penetrations than left involvement.
Generally speaking, the lesions can disturb voluntary movements during the mouth, the control
of the bolus and its continence, but also its transport to the esophagus. Sensory and
gustatory disorders may also result. Combined with a lack of respiratory protection, these
difficulties increase the risk of food choking, which are a vital issue.
Swallowing has three phases. During oral, voluntary time, muscle control of the lips, tongue,
mandible is essential for mouthing and handling food. While labial continence prevents
leakage, mandibular chewing movements allow food to be crushed. The movements of the language
contribute to the formation of a compact and centered bolus, before being projected by its
recoil. These movements consist of the progressive support from front to back of the lingual
apex, the deformation "in the back of the spoon" of the tongue, the recoil of the base. This
organ still intervenes after swallowing, to drain the oral cavity and eliminate any food
stasis. The innervations involved in this oral time concern the nuclei of the nerves V, VII
and XII. Pharyngeal time, reflex, requires an effective protection of the lower airways,
involving glottic closure, the tilt of the arytenoids, the ascent of the larynx against the
tongue base and the tilt of the epiglottis. The veil of the palate must allow an effective
restraint to avoid any nasal reflux. Sensory damage caused by a stroke and laryngeal
mobilization defects can be factors of penetrations, whereas they made all the more dangerous
as the cough reflex can be ineffective or abolished. The last stage of swallowing is
oesophageal. It is based on peristalsis allowing the transport of the bolus to the digestive
tract. Blockages can occur, causing pain, discomfort, feelings of stuck food. Thus,
swallowing is described as a complex skill, highly dependent on neurological control systems
and organ function, combining coordination and precision. We propose here to act on oral
time, which requires tonic and precise voluntary movements.
Classic care in stroke is multidisciplinary, intensive in the acute phase, and necessarily
early. Indeed, patients starting rehabilitation within the first twenty days of the accident
have a better probability of effective therapeutic response than those taken care of after
those twenty days. Rehabilitation focuses on three main approaches: restoration, compensation
and modification. The restoration aims to re-train damaged parts of the nervous system to
regain lost functions. Compensation seeks to adapt behaviour to deficits, without solving
them, or to use brain reorganization to relearn lost functions. Finally, the modification
plays on the patient's environmental framework to prevent risks and facilitate the functions
involved in daily life. The rehabilitation of swallowing is based on the same principles. The
effects of very early rehabilitation are difficult to demonstrate due to the high proportion
of spontaneous recovery. Rehabilitation will guide recovery, with a view to progressive
evolution. The first clinical signs of dysphagia are observed by caregivers during the first
meals given during hospitalization. In parallel with the demand for speech therapy, the first
preventive measures are put in place: thickening of the water and anterior bending of the
head during swallowing. The speech therapy assessment then makes it possible to account for
functional deficits, to adapt the textures, the amount taken and the postures. We can try, by
the modifications of textures, to slow down the bolus in case of risk of false route before
the reflex. Conversely, in the context of a propulsion deficit, more fluid and liquid
consistencies are proposed. Rehabilitation is also specific and targeted on anatomical and
neuromuscular abnormalities, in the form of analytical exercises of basic language
strengthening, lingual control, labio-jugal tonicity. The care is performed in a passive mode
based on the stimulation of reflexes and actively with analytical exercises at the level of
the oro-bucco-facial sphere, pharynx, laryngeal motor or glottic closure. For oral time,
particular use is made of tactile, thermal and oral-facial stimuli.
Functional rehabilitation is based on the neuroplasticity present in adults throughout life.
Brain plasticity is demonstrated by changes in neural structure and synaptic force, in
contexts of adaptation to external stimuli or damage to structures. The brain compensates for
the damage by reorganizing neural networks and creating new connections between the preserved
neurons. Recent studies suggest that changes in myelin, by the length of the sheath, its
thickness and its distribution would be involved in the dynamics of neural circuits in
adults. In the case of vascular diseases, recovery will be influenced by many factors,
including the type of lesion, the intensity of rehabilitation, the cognitive reserve specific
to the patient but also genetic factors influencing neuroplasticity abilities. Indeed, some
genetic polymorphisms could affect an individual's ability to learn and recover. Thus, there
are important inter-individual differences in recovery for the same care protocol in clinical
practice. Older adults have the same variability and reorganisation opportunities for
functional recovery.
Many studies have looked for links between oral movements and manual skills. At the level of
the jaw, some authors have shown the influence of the position of the mandible on the
grapho-motor gesture, in connection with the stabilization of the spine. With regard to the
intra-oral sphere, motor links to manual precision have been studied in the context of joint
disorders. The results show a correlation between manual fine motor skills and joint
movements for language in production during development. In the very young child, oral
exploration and the hand-mouth link are at the heart of the exploration of the environment
and the construction of the engine schemes. For example in the development of orality, he
must learn a new motor sequence simultaneously at the oral level and at the manual level when
switching to the spoon. This oral gnoso-praxic development supports the development of fine
motor skills. Training in digital practices, cutting, would improve oral practices,
especially lingual ones. On the neuroanatomical level, Penfield had indeed established by
electrostimulation a somatosensory and motor cortical proximity between hand and mouth. A
hand-mouth loop was also reported as simultaneous motor activation of the two areas after
cortical stimulation. This primitive synergy, also present in some monkeys, is found by
electro-stimulation at ten sites of the pre-central gyrus in adult and child subjects. A
difference in stimulation intensity at these sites would not trigger the activation of the
mouth or arm separately, the two movements triggering at the same threshold: the mouth
opening simultaneously at the flexion of the arm to approach the closed hand. The synergistic
cortical sites would be separated by other areas involving the upper limb or the mouth
independently.
We propose to study these hand-to-mouth relationships in a population that is no longer in
development, with a view to rehabilitation and plasticity in elderly patients who have
suffered injuries. This study would make it possible to analyze oral movements related to
oral swallowing time and manual movements as part of fine motor training.
We hypothesize that the addition of manual fine motor training to conventional speech therapy
will improve the recovery of oral time motion from swallowing in post-stroke patients.
