Rehabilitation Protocol for Disorders on Hand Sensitivity in Multiple Sclerosis Patients.

Multiple Sclerosis Clinical Trial

— FINGER  

Official title:

Rehabilitation Protocol for Disorders on Hand Sensitivity in Multiple Sclerosis Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866878
• Other study ID #: 12-PP-13
• Status: Completed
• Phase: N/A
• First received: April 30, 2013
• Last updated: March 8, 2018
• Start date: July 30, 2013
• Est. completion date: July 28, 2015

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 28, 2015
• Est. primary completion date: July 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• equipment rehabilitation stereognosis

• TENS

Locations

Country	Name	City	State
France	Hôpital Pasteur	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare quality of life between baseline and procedure	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
Secondary	Compare the performance during functional tests between baseline and procedure	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
Secondary	Compare the improvement clinically sensitive target from baseline procedure	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