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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
equipment rehabilitation stereognosis
TENS
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring transcutaneous electrical nerve stimulation, sensitivity, multiple sclerosis,Reeducation through labor tactile discrimination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Pasteur

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

A group enjoying a corrective touch

A group receiving TENS (TENS)

A control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Full Information

First Posted
April 30, 2013
Last Updated
March 8, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT01866878
Brief Title
Rehabilitation Protocol for Disorders on Hand Sensitivity in Multiple Sclerosis Patients.
Acronym
FINGER
Official Title
Rehabilitation Protocol for Disorders on Hand Sensitivity in Multiple Sclerosis Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 30, 2013 (Actual)
Primary Completion Date
July 28, 2015 (Actual)
Study Completion Date
July 28, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
transcutaneous electrical nerve stimulation, sensitivity, multiple sclerosis,Reeducation through labor tactile discrimination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A group enjoying a corrective touch
Arm Type
Experimental
Arm Description
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.
Arm Title
A group receiving TENS (TENS)
Arm Type
Experimental
Arm Description
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.
Arm Title
A control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
equipment rehabilitation stereognosis
Intervention Type
Device
Intervention Name(s)
TENS
Primary Outcome Measure Information:
Title
Compare quality of life between baseline and procedure
Description
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
Time Frame
frist day, 1 month and 3 month
Secondary Outcome Measure Information:
Title
Compare the performance during functional tests between baseline and procedure
Description
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
Time Frame
first day, 1 month and 3 month
Title
Compare the improvement clinically sensitive target from baseline procedure
Description
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.
Time Frame
first day, 1 month and 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikael COHEN, Medical Doctor
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Pasteur
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

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

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