- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01866878
Rehabilitation Protocol for Disorders on Hand Sensitivity in Multiple Sclerosis Patients. (FINGER)
Sensory disorders in patients with multiple sclerosis are among the most common symptoms encountered.
A functional impairment based on sensory disorders of the hand. The hand is a sensory organ that transmits the cerebral cortex protopathic sensitive information, proprioceptive or epicritiques. The view-hand association plays an important role in the understanding of the environment. Its exploratory use remains an essential and voluntary basis. The process of recognition of the object passes through manipulation, but operates instantaneously. The brain is able to do a quick summary of the information it receives to determine the nature of the manipulated object. The exploration takes a posteriori, the brain can then determine the details component object (texture, shape, composition, temperature and weight).
Neurophysiological mechanisms that would explain the analgesic effects of transcutaneous electrical nerve stimulation (TENS) are not fully understood. Several theories underlying its use as a neuromodulator of pain. The gate control theory has led to the development of TENS devices. Recruitment of myelinated, large caliber, by the TENS electrodes afferent fibers increases the control exerted on spinal level, thereby inhibiting the action of afferent fibers of small caliber related to nociception. This stimulation strengthens the blocking of "gate" at the corresponding cell bodies of spinothalamic tract and reduces the transmission of nociceptive impulses to the spinal cord dorsal horn. This is segmental presynaptic inhibition depends on the area and stimulated.
The objective of this study is to improve the quality of life through improved sensitivity disorders of the hand in patients with MS, thanks to reeducation of the hand.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Nice, France, 06000
- Hôpital Pasteur
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients with relapsing remitting MS defined according to Poser criteria [9] and McDonald [5].
- Age ≥ 18 years, male or female sex
- Patients with sensory disorders interesting hands, evidenced by clinical examination objective.
- Patients with an EDSS between 2 and 4 with functional sensitivity parameter ≥ 2.
- Patients affiliated to a social security scheme.
- Patients signed informed consent for the study.
Exclusion Criteria:
- Patients with other central or peripheral disorders may affect the sensitivity of the hand.
- Patients with allodynia in the study area
- Patients with a motor and / or deficit cerebellar ataxia of the upper limbs.
- Patients treated with psychotropic or antiepileptic drugs.
- Patients for whom a flare occurred affecting the sensitivity of the hand, within 30 days before enrollment.
- Patients holders of an active implantable medical device.
- Pregnant women and vulnerable patient population.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: A group enjoying a corrective touch
At first, the patient is asked to gradually define the different types of touch that is applied to the hyposensitive area (fixed or mobile touches) with different textures and then compare them with the healthy side. In a second step, the patient is asked to associate multiple items sensation shape and texture, shape and weight. In a third step is used everyday objects. Desensitisation techniques find their interest mainly when symptoms or dysesthetic hyperesthésique. The objective is to increase the threshold of sensitivity to textures and particles eventually reduce dysaesthetic sensations. The patient class in order of increasing tolerance 10 textures. Dysesthetic area is stimulated 5 to 10 minutes by the first texture to numb the area by saturation of the action potential. This helps promote functional work and recognition of objects. As soon as the texture causes more trouble we go to the next texture by applying the same job. |
|
Expérimental: A group receiving TENS (TENS)
Well known in the management of neuropathic pain based on the gate control theory, the application of TENS in the rehabilitation of touch remains to be demonstrated.
A recent study applied to the September highlighted the long-term interest of the transcutaneous electrical nerve stimulation (TENS) to improve sensitivity tact arguing possible action on brain plasticity.
|
|
Aucune intervention: A control group
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Compare quality of life between baseline and procedure
Délai: frist day, 1 month and 3 month
|
Improve the quality of life through improved sensitivity disorders of the hand in patients with MS, thanks to reeducation of the hand. Unit of mesure: scale MusiQoL |
frist day, 1 month and 3 month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Compare the performance during functional tests between baseline and procedure
Délai: first day, 1 month and 3 month
|
Improve performance of MS patients during functional tests in patients undergoing rehabilitation treatment compared to the control group. Using picking up test and thr Nine Hole Peg Test |
first day, 1 month and 3 month
|
Compare the improvement clinically sensitive target from baseline procedure
Délai: first day, 1 month and 3 month
|
Improve clinically sensitive target of MS patients through a rehabilitation treatment compared to the control group. Using the Threshold pressure, the Threshold to the vibration and the Weber test. |
first day, 1 month and 3 month
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Mikael COHEN, Medical Doctor, Centre Hospitalier Universitaire de Nice
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12-PP-13
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur DIZAINES
-
Yeditepe UniversityActif, ne recrute pasPhysiothérapie sportive | Douleur, ÉpauleTurquie
-
Cropper MedicalComplété
-
Thync Global, Inc.ethica Clinical Research Inc.ComplétéStresser | PsoriasisÉtats-Unis
-
University Hospital, AkershusComplétéFractures de la claviculeNorvège