- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02354248
Application of the Triple Stimulation Technique to Patients With CNS Disorders Including Stroke
TST (Triple stimulation technique) helps to better quantify the proportion of motor units activated by transcranial magnetic stimulation. The abnormal amplitude registered by TST is proportional to the intensity of conduction disorders. The evaluation of these disorders is more precise with this technique than with the slowing of the central conduction time (CCT).
The investigators propose to use this technique in CNS pathologies where this disorder is significant and essential, like multiple sclerosis and stroke.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Brussels, Belgium, 1020
- CHU Brugmann
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- stroke patients with hemiparesia
Exclusion Criteria:
- pace maker
- epilepsia
- metallic neurosurgical implants
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stroke patients
The patients will be submitted to a triple stimulation examination.
|
Evoked motor potentials obtained by magnetic transcranial stimulation are usually used, in standard practice, to evaluate the corticospinal tract.
This procedure combines two techniques: the magnetic stimulation and the electroneuromyography.
It is based on the double collision principle between the descending central stimulation (magnetic) and the ascending peripheric stimulation, hereby suppressing the issue of desynchronisation of evoked motor potentials.
The Triple stimulation technique allows a better quantification of the proportion of motor units activated by the transcranial stimulation.
|
Active Comparator: Control Subjects
This group of patients did not suffer from a stroke.
They will also be submitted to a triple stimulation examination.
|
Evoked motor potentials obtained by magnetic transcranial stimulation are usually used, in standard practice, to evaluate the corticospinal tract.
This procedure combines two techniques: the magnetic stimulation and the electroneuromyography.
It is based on the double collision principle between the descending central stimulation (magnetic) and the ascending peripheric stimulation, hereby suppressing the issue of desynchronisation of evoked motor potentials.
The Triple stimulation technique allows a better quantification of the proportion of motor units activated by the transcranial stimulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amplitude of the motor evoked potentials
Time Frame: during the TST (30 min)
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during the TST (30 min)
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Amplitude ratio of the TST
Time Frame: during the TST (30 min)
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during the TST (30 min)
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Surface ratio of the TST
Time Frame: during the TST (30 min)
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during the TST (30 min)
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Surface of the motor evoked potentials
Time Frame: during the TST (30 min)
|
during the TST (30 min)
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TMS threshold
Time Frame: during TST (30 min)
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during TST (30 min)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pedro Calderon, MD, CHU Brugmann
- Principal Investigator: Bernard Dachy, MD, CHU Brugmann
- Principal Investigator: Andrey Bragin, MD, CHU Brugmann
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB-TST01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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