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

March 8, 2018 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Hôpital Pasteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: equipment rehabilitation stereognosis
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.
Device: TENS
No Intervention: A control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare quality of life between baseline and procedure
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the performance during functional tests between baseline and procedure
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Study Director: Mikael COHEN, Medical Doctor, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2013

Primary Completion (Actual)

July 28, 2015

Study Completion (Actual)

July 28, 2015

Study Registration Dates

First Submitted

April 30, 2013

First Submitted That Met QC Criteria

May 27, 2013

First Posted (Estimate)

June 3, 2013

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-PP-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on TENS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe