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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02805634
Other study ID # CHUB-TST02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 9, 2016
Est. completion date January 30, 2019

Study information

Verified date April 2019
Source Brugmann University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 30, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Belgium CHU Brugmann Brussels

Sponsors (1)

Lead Sponsor Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (16)

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. Epub 2003 Jun 24. — View Citation

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. — View Citation

Bühler R, Magistris MR, Truffert A, Hess CW, Rösler KM. The triple stimulation technique to study central motor conduction to the lower limbs. Clin Neurophysiol. 2001 May;112(5):938-49. — View Citation

Chan T. An investigation of finger and manual dexterity. Percept Mot Skills. 2000 Apr;90(2):537-42. — View Citation

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. — View Citation

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. — View Citation

Erasmus LP, Sarno S, Albrecht H, Schwecht M, Pöllmann W, König 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. — View Citation

Humm AM, Beer S, Kool J, Magistris MR, Kesselring J, Rösler KM. Quantification of Uhthoff's phenomenon in multiple sclerosis: a magnetic stimulation study. Clin Neurophysiol. 2004 Nov;115(11):2493-501. — View Citation

Humm AM, Z'Graggen WJ, Bühler R, Magistris MR, Rösler 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. Epub 2005 Sep 20. — View Citation

Humm AM, Z'Graggen WJ, von Hornstein NE, Magistris MR, Rösler 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. — View Citation

Kellor M, Frost J, Silberberg N, Iversen I, Cummings R. Hand strength and dexterity. Am J Occup Ther. 1971 Mar;25(2):77-83. — View Citation

Magistris MR, Rösler 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. — View Citation

Magistris MR, Rösler 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. — View Citation

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. — View Citation

Rösler 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. — View Citation

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. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Amplitude of the motor evoked potentials during the TST (30 min)
Primary Amplitude ratio of the TST during the TST (30 min)
Primary Surface ratio of the TST during the TST (30 min)
Primary Nine Holes Peg test result Baseline
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