NCT02805634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

March 31, 2016

Last Update Submit

April 16, 2019

Conditions

Keywords

nine holes pegtriple stimulationmultiple sclerosis

Outcome Measures

Primary Outcomes (4)

  • Amplitude of the motor evoked potentials

    during the TST (30 min)

  • Amplitude ratio of the TST

    during the TST (30 min)

  • Surface ratio of the TST

    during the TST (30 min)

  • Nine Holes Peg test result

    Baseline

Study Arms (2)

Multiple sclerosis

EXPERIMENTAL

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

Other: Nine Hole TestDevice: Triple Stimulation Technique

Control group

OTHER

Control group without neurological pathology

Other: Nine Hole TestDevice: Triple Stimulation Technique

Interventions

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.

Control groupMultiple 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.

Control groupMultiple sclerosis

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (16)

  • Magistris MR, Rosler KM, Truffert A, Myers JP. Transcranial stimulation excites virtually all motor neurons supplying the target muscle. A demonstration and a method improving the study of motor evoked potentials. Brain. 1998 Mar;121 ( Pt 3):437-50. doi: 10.1093/brain/121.3.437.

    PMID: 9549520BACKGROUND
  • Magistris MR, Rosler KM, Truffert A, Landis T, Hess CW. A clinical study of motor evoked potentials using a triple stimulation technique. Brain. 1999 Feb;122 ( Pt 2):265-79. doi: 10.1093/brain/122.2.265.

    PMID: 10071055BACKGROUND
  • Buhler R, Magistris MR, Truffert A, Hess CW, Rosler KM. The triple stimulation technique to study central motor conduction to the lower limbs. Clin Neurophysiol. 2001 May;112(5):938-49. doi: 10.1016/s1388-2457(01)00506-5.

    PMID: 11336912BACKGROUND
  • Humm AM, Beer S, Kool J, Magistris MR, Kesselring J, Rosler KM. Quantification of Uhthoff's phenomenon in multiple sclerosis: a magnetic stimulation study. Clin Neurophysiol. 2004 Nov;115(11):2493-501. doi: 10.1016/j.clinph.2004.06.010.

    PMID: 15465437BACKGROUND
  • Humm AM, Z'Graggen WJ, von Hornstein NE, Magistris MR, Rosler KM. Assessment of central motor conduction to intrinsic hand muscles using the triple stimulation technique: normal values and repeatability. Clin Neurophysiol. 2004 Nov;115(11):2558-66. doi: 10.1016/j.clinph.2004.06.009.

    PMID: 15465445BACKGROUND
  • Humm AM, Z'Graggen WJ, Buhler R, Magistris MR, Rosler KM. Quantification of central motor conduction deficits in multiple sclerosis patients before and after treatment of acute exacerbation by methylprednisolone. J Neurol Neurosurg Psychiatry. 2006 Mar;77(3):345-50. doi: 10.1136/jnnp.2005.065284. Epub 2005 Sep 20.

    PMID: 16174651BACKGROUND
  • Rosler KM, Scheidegger O, Magistris MR. Corticospinal output and loss of force during motor fatigue. Exp Brain Res. 2009 Aug;197(2):111-23. doi: 10.1007/s00221-009-1897-z. Epub 2009 Jul 2.

    PMID: 19572125BACKGROUND
  • Andersen B, Westlund B, Krarup C. Failure of activation of spinal motoneurones after muscle fatigue in healthy subjects studied by transcranial magnetic stimulation. J Physiol. 2003 Aug 15;551(Pt 1):345-56. doi: 10.1113/jphysiol.2003.043562. Epub 2003 Jun 24.

    PMID: 12824449BACKGROUND
  • Attarian S, Verschueren A, Pouget J. Magnetic stimulation including the triple-stimulation technique in amyotrophic lateral sclerosis. Muscle Nerve. 2007 Jul;36(1):55-61. doi: 10.1002/mus.20789.

    PMID: 17443663BACKGROUND
  • Tan F, Wang X, Li HQ, Lu L, Li M, Li JH, Fang M, Meng D, Zheng GQ. A randomized controlled pilot study of the triple stimulation technique in the assessment of electroacupuncture for motor function recovery in patients with acute ischemic stroke. Evid Based Complement Alternat Med. 2013;2013:431986. doi: 10.1155/2013/431986. Epub 2013 Jun 10.

    PMID: 23840255BACKGROUND
  • Oxford Grice K, Vogel KA, Le V, Mitchell A, Muniz S, Vollmer MA. Adult norms for a commercially available Nine Hole Peg Test for finger dexterity. Am J Occup Ther. 2003 Sep-Oct;57(5):570-3. doi: 10.5014/ajot.57.5.570.

    PMID: 14527120BACKGROUND
  • Chan T. An investigation of finger and manual dexterity. Percept Mot Skills. 2000 Apr;90(2):537-42. doi: 10.2466/pms.2000.90.2.537.

    PMID: 10833751BACKGROUND
  • Kellor M, Frost J, Silberberg N, Iversen I, Cummings R. Hand strength and dexterity. Am J Occup Ther. 1971 Mar;25(2):77-83. No abstract available.

    PMID: 5551515BACKGROUND
  • Chen HM, Chen CC, Hsueh IP, Huang SL, Hsieh CL. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009 Jun;23(5):435-40. doi: 10.1177/1545968308331146. Epub 2009 Mar 4.

    PMID: 19261767BACKGROUND
  • Earhart GM, Cavanaugh JT, Ellis T, Ford MP, Foreman KB, Dibble L. The 9-hole PEG test of upper extremity function: average values, test-retest reliability, and factors contributing to performance in people with Parkinson disease. J Neurol Phys Ther. 2011 Dec;35(4):157-63. doi: 10.1097/NPT.0b013e318235da08.

    PMID: 22020457BACKGROUND
  • Erasmus LP, Sarno S, Albrecht H, Schwecht M, Pollmann W, Konig N. Measurement of ataxic symptoms with a graphic tablet: standard values in controls and validity in Multiple Sclerosis patients. J Neurosci Methods. 2001 Jul 15;108(1):25-37. doi: 10.1016/s0165-0270(01)00373-9.

    PMID: 11459615BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bernard Bernard, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR
  • Pedro Calderon, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

March 31, 2016

First Posted

June 20, 2016

Study Start

February 9, 2016

Primary Completion

January 30, 2019

Study Completion

January 30, 2019

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations