Multiple SclerosisNCT02805634
Correlation Between the 'Nine Holes Peg Test' Performance and the Triple Stimulation Technique Within a Group a Patients With Multiple Sclerosis
A study testing Nine Hole Test and Triple Stimulation Technique in people with Multiple Sclerosis, run by Brugmann University Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Nine Hole Test and Triple Stimulation Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Feb 2016to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Nine Hole Test, Triple Stimulation Technique
- Keywords
- nine holes peg, triple stimulation, multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nine Hole TestOther
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.
Triple Stimulation TechniqueDevice
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 group | Role | What they receive |
|---|---|---|
| Multiple sclerosis | Experimental | Patients with multiple sclerosis, followed by Dr Dachy within the CHU Brugmann Hospital. Receives: Other: Nine Hole Test; Device: Triple Stimulation Technique |
| Control group | Other | Control group without neurological pathology Receives: Other: Nine Hole Test; Device: Triple Stimulation Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of the motor evoked potentials
Measured: during the TST (30 min)
Amplitude ratio of the TST
Measured: during the TST (30 min)
Surface ratio of the TST
Measured: during the TST (30 min)
Nine Holes Peg test result
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start9 Feb 2016
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard Dachy, Brugmann University Hospital
- Investigators
- Bernard Bernard, MD, Principal investigator, CHU BrugmannPedro Calderon, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805634
- Sponsor's protocol ID
- CHUB-TST02
- Status last verified
- Apr 2019
- First submitted
- 31 Mar 2016
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9549520Magistris 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.
PubMed 10071055Buhler 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.
PubMed 11336912Humm 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.
PubMed 15465437Humm 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.
PubMed 15465445Humm 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.
PubMed 16174651Rosler 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.
PubMed 19572125Andersen 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.
PubMed 12824449Attarian 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.
PubMed 17443663Tan 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.
PubMed 23840255Oxford 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.
PubMed 14527120Chan 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.
PubMed 10833751Kellor 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.
PubMed 5551515Chen 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.
PubMed 19261767Earhart 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.
PubMed 22020457
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the 'Nine Holes Peg Test' Performance and the Triple Stimulation Technique Within a Group a Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02805634
- Acronym / sponsor ID
- CHUB-TST02
- Conditions
- Multiple Sclerosis
- Keywords
- nine holes peg, triple stimulation, multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 9 Feb 2016 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis | Experimental | Other: Nine Hole Test, Device: Triple Stimulation TechniquePatients with multiple sclerosis, followed by Dr Dachy within the CHU Brugmann Hospital. |
| Control group | Other | Other: Nine Hole Test, Device: Triple Stimulation TechniqueControl group without neurological pathology |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nine Hole TestThe 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. | Other | Control group, Multiple sclerosis |
| Triple Stimulation TechniqueTST (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. | Device | Control group, Multiple sclerosis |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Background: PubMed 9549520Magistris 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.
- Background: PubMed 10071055Magistris 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.
- Background: PubMed 11336912Buhler 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.
- Background: PubMed 15465437Humm 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.
- Background: PubMed 15465445Humm 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.
- Background: PubMed 16174651Humm 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.
- Background: PubMed 19572125Rosler 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.
- Background: PubMed 12824449Andersen 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.
- Background: PubMed 17443663Attarian 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.
- Background: PubMed 23840255Tan 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.
- Background: PubMed 14527120Oxford 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.
- Background: PubMed 10833751Chan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Bernard, MD principal investigator
CHU Brugmann
Pedro Calderon, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nine Hole Test and Triple Stimulation Technique in people with Multiple Sclerosis, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of the motor evoked potentials (time frame: during the TST (30 min)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02805634, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.