Back to resultsApplication of the Triple Stimulation Technique to Patients With CNS Disorders Including Stroke
Primary Purpose
Stroke Patients
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Triple stimulation technique
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke Patients focused on measuring TST, TMS, Stroke patients, EMG
Eligibility Criteria
Inclusion Criteria:
- stroke patients with hemiparesia
Exclusion Criteria:
- pace maker
- epilepsia
- metallic neurosurgical implants
Sites / Locations
- CHU Brugmann
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Stroke patients
Control Subjects
Arm Description
The patients will be submitted to a triple stimulation examination.
This group of patients did not suffer from a stroke. They will also be submitted to a triple stimulation examination.
Outcomes
Primary Outcome Measures
Amplitude of the motor evoked potentials
Surface of the motor evoked potentials
Amplitude ratio of the TST
Surface ratio of the TST
TMS threshold
Secondary Outcome Measures
Full Information
NCT ID
NCT02354248
First Posted
January 23, 2015
Last Updated
January 18, 2018
Sponsor
Brugmann University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02354248
Brief Title
Application of the Triple Stimulation Technique to Patients With CNS Disorders Including Stroke
Official Title
Application of the Triple Stimulation Technique to Patients With CNS Disorders Including Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 11, 2014 (Actual)
Primary Completion Date
September 13, 2016 (Actual)
Study Completion Date
September 13, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Patients
Keywords
TST, TMS, Stroke patients, EMG
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stroke patients
Arm Type
Experimental
Arm Description
The patients will be submitted to a triple stimulation examination.
Arm Title
Control Subjects
Arm Type
Active Comparator
Arm Description
This group of patients did not suffer from a stroke. They will also be submitted to a triple stimulation examination.
Intervention Type
Procedure
Intervention Name(s)
Triple stimulation technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Amplitude of the motor evoked potentials
Time Frame
during the TST (30 min)
Title
Surface of the motor evoked potentials
Time Frame
during the TST (30 min)
Title
Amplitude ratio of the TST
Time Frame
during the TST (30 min)
Title
Surface ratio of the TST
Time Frame
during the TST (30 min)
Title
TMS threshold
Time Frame
during TST (30 min)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
stroke patients with hemiparesia
Exclusion Criteria:
pace maker
epilepsia
metallic neurosurgical implants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Dachy, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrey Bragin, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pedro Calderon, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
9549520
Citation
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.
Results Reference
background
PubMed Identifier
10071055
Citation
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.
Results Reference
background
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Application of the Triple Stimulation Technique to Patients With CNS Disorders Including Stroke
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