Clinical trial NCT01866878: Rehabilitation Protocol for Disorders on Hand Sensitivity in Multiple Sclerosis Patients.
Official title: Rehabilitation Protocol for Disorders on Hand Sensitivity in Multiple Sclerosis Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: transcutaneous electrical nerve stimulation, sensitivity, multiple sclerosis,Reeducation through labor tactile discrimination
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Compare quality of life between baseline and procedure
timeFrame: frist day, 1 month and 3 month
Secondary outcomes:
measure: Compare the performance during functional tests between baseline and procedure
timeFrame: first day, 1 month and 3 month
measure: Compare the improvement clinically sensitive target from baseline procedure
timeFrame: first day, 1 month and 3 month
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital Pasteur
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Mikael COHEN, Medical Doctor
role: STUDY_DIRECTOR
References: