NCT02354248

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

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

June 11, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2016

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

2.3 years

First QC Date

January 23, 2015

Last Update Submit

January 18, 2018

Conditions

Keywords

TSTTMSStroke patientsEMG

Outcome Measures

Primary Outcomes (5)

  • Amplitude of the motor evoked potentials

    during the TST (30 min)

  • Surface 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)

  • TMS threshold

    during TST (30 min)

Study Arms (2)

Stroke patients

EXPERIMENTAL

The patients will be submitted to a triple stimulation examination.

Procedure: Triple stimulation technique

Control Subjects

ACTIVE COMPARATOR

This group of patients did not suffer from a stroke. They will also be submitted to a triple stimulation examination.

Procedure: Triple stimulation technique

Interventions

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.

Control SubjectsStroke patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stroke patients with hemiparesia

You may not qualify if:

  • pace maker
  • epilepsia
  • metallic neurosurgical implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (2)

  • 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

Study Officials

  • Bernard Dachy, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR
  • Andrey Bragin, 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

January 23, 2015

First Posted

February 3, 2015

Study Start

June 11, 2014

Primary Completion

September 13, 2016

Study Completion

September 13, 2016

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations