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Correlation Between the 'Nine Holes Peg Test' Performance and the Triple Stimulation Technique Within a Group a Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Nine Hole Test
Triple Stimulation Technique
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring nine holes peg, triple stimulation, multiple sclerosis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Control group:

  • No history of neurological disease
  • No medicines intake that could disturb performance within the tests (psychotropic medications, sedatives, anti spastic and drugs acting on neuromuscular transmission).

Multiple sclerosis group

  • Multiple sclerosis diagnose. Patients followed by Dr Dachy, within the CHU Brugmann Hospital.

Exclusion Criteria:

  • Persons carrying ferromagnetic material (implants, pacemaker).
  • Epilepsy history.
  • Patients who have had a head trauma with loss of consciousness and/or brain injury.
  • Pregnant woman.

Sites / Locations

  • CHU Brugmann

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Multiple sclerosis

Control group

Arm Description

Patients with multiple sclerosis, followed by Dr Dachy within the CHU Brugmann Hospital.

Control group without neurological pathology

Outcomes

Primary Outcome Measures

Amplitude of the motor evoked potentials
Amplitude ratio of the TST
Surface ratio of the TST
Nine Holes Peg test result

Secondary Outcome Measures

Full Information

First Posted
March 31, 2016
Last Updated
April 16, 2019
Sponsor
Brugmann University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02805634
Brief Title
Correlation Between the 'Nine Holes Peg Test' Performance and the Triple Stimulation Technique Within a Group a Patients With Multiple Sclerosis
Official Title
Correlation Between the 'Nine Holes Peg Test' Performance and the Triple Stimulation Technique Within a Group a Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 9, 2016 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main goal of this study is to determine if the Triple Stimulation Technique (TST) can be correlated to performance in the manual dexterity 'nine holes peg' test, within a control group and a group of patients with multiple sclerosis. TST (Triple stimulation technique) combines two techniques used in neurologic diagnosis: magnetic stimulation and electroneuromyography. It is based on the principle of two collisions between the descending central stimulation (magnetic stimulation) and the ascending peripheric stimulation. TST allows to better quantify central nervous system diseases. The abnormal amplitude registered by TST is proportional to the intensity of conduction disorders. The evaluation of these disorders is more precise than with the magnetic stimulation technique alone. The Nine Hole Pegs technique is a simple manual dexterity test, commonly used in ergotherapy. The participant tries to place 9 pegs in a 9 holes perforated plate, and then tries to remove them as quickly as possible. The hand must stay in a depression within the plate, thereby insuring a constant distance between the hand and the pegs. The nine hole peg will be realized first, and the triple stimulation examination performed after. The acquired data will be analyzed in order to find a correlation between the impairment level given by these two tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
nine holes peg, triple stimulation, multiple sclerosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiple sclerosis
Arm Type
Experimental
Arm Description
Patients with multiple sclerosis, followed by Dr Dachy within the CHU Brugmann Hospital.
Arm Title
Control group
Arm Type
Other
Arm Description
Control group without neurological pathology
Intervention Type
Other
Intervention Name(s)
Nine Hole Test
Intervention Description
The Nine Hole Pegs technique is a simple manual dexterity test, commonly used in ergotherapy. The participant tries to place 9 pegs in a 9 holes perforated plate, and then tries to remove them as quickly as possible. The hand must stay in a depression within the plate, thereby insuring a constant distance between the hand and the pegs.
Intervention Type
Device
Intervention Name(s)
Triple Stimulation Technique
Intervention Description
TST (Triple stimulation technique) combines two techniques used in neurologic diagnosis: magnetic stimulation and electroneuromyography. It is based on the principle of two collisions between the descending central stimulation (magnetic stimulation) and the ascending peripheric stimulation. TST allows to better quantify central nervous system diseases. The abnormal amplitude registered by TST is proportional to the intensity of conduction disorders. The evaluation of these disorders is more precise than with the magnetic stimulation technique alone.
Primary Outcome Measure Information:
Title
Amplitude of the motor evoked potentials
Time Frame
during the TST (30 min)
Title
Amplitude ratio of the TST
Time Frame
during the TST (30 min)
Title
Surface ratio of the TST
Time Frame
during the TST (30 min)
Title
Nine Holes Peg test result
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Control group: No history of neurological disease No medicines intake that could disturb performance within the tests (psychotropic medications, sedatives, anti spastic and drugs acting on neuromuscular transmission). Multiple sclerosis group Multiple sclerosis diagnose. Patients followed by Dr Dachy, within the CHU Brugmann Hospital. Exclusion Criteria: Persons carrying ferromagnetic material (implants, pacemaker). Epilepsy history. Patients who have had a head trauma with loss of consciousness and/or brain injury. Pregnant woman.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Bernard, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pedro Calderon, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium

12. IPD Sharing Statement

Citations:
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Correlation Between the 'Nine Holes Peg Test' Performance and the Triple Stimulation Technique Within a Group a Patients With Multiple Sclerosis

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