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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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ClinicalTrials.gov Identifier: NCT02805634
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Bernard Dachy, Brugmann University Hospital

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE June 20, 2016
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE February 9, 2016
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2016)
  • Amplitude of the motor evoked potentials [ Time Frame: during the TST (30 min) ]
  • Amplitude ratio of the TST [ Time Frame: during the TST (30 min) ]
  • Surface ratio of the TST [ Time Frame: during the TST (30 min) ]
  • Nine Holes Peg test result [ Time Frame: Baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02805634 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Correlation Between the 'Nine Holes Peg Test' Performance and the Triple Stimulation Technique Within a Group a Patients With Multiple Sclerosis
Official Title  ICMJE Correlation Between the 'Nine Holes Peg Test' Performance and the Triple Stimulation Technique Within a Group a Patients With Multiple Sclerosis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Other: Nine Hole Test
    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.
  • Device: Triple Stimulation Technique
    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.
Study Arms  ICMJE
  • Experimental: Multiple sclerosis
    Patients with multiple sclerosis, followed by Dr Dachy within the CHU Brugmann Hospital.
    Interventions:
    • Other: Nine Hole Test
    • Device: Triple Stimulation Technique
  • Control group
    Control group without neurological pathology
    Interventions:
    • Other: Nine Hole Test
    • Device: Triple Stimulation Technique
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 30, 2019
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02805634
Other Study ID Numbers  ICMJE CHUB-TST02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bernard Dachy, Brugmann University Hospital
Study Sponsor  ICMJE Brugmann University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bernard Bernard, MD CHU Brugmann
Principal Investigator: Pedro Calderon, MD CHU Brugmann
PRS Account Brugmann University Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP