- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Nice, Francia, 06000
- Hôpital Pasteur
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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. |
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Experimental: 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.
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Sin intervención: A control group
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Compare quality of life between baseline and procedure
Periodo de tiempo: 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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Compare the performance during functional tests between baseline and procedure
Periodo de tiempo: 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
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Compare the improvement clinically sensitive target from baseline procedure
Periodo de tiempo: 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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Mikael COHEN, Medical Doctor, Centre Hospitalier Universitaire de Nice
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12-PP-13
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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