Stroke PatientsNCT02354248
Application of the Triple Stimulation Technique to Patients With CNS Disorders Including Stroke
A study testing Triple stimulation technique in people with Stroke Patients, run by Brugmann University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke Patients
- What is being tested?
- Triple stimulation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Jun 2014to 13 Sep 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- stroke patients with hemiparesia
Who cannot join
- pace maker
- epilepsia
- metallic neurosurgical implants
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stroke Patients
- Being tested
- Triple stimulation technique
- Keywords
- TST, TMS, Stroke patients, EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple stimulation techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Experimental | The patients will be submitted to a triple stimulation examination. Receives: 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. Receives: Procedure: 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)
Surface 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)
TMS threshold
Measured: during TST (30 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study start11 Jun 2014
- Primary completion13 Sep 2016
- Study completion13 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke PatientsStudies 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
- 100 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 Dachy, MD, Principal investigator, CHU BrugmannAndrey Bragin, MD, Principal investigator, CHU BrugmannPedro Calderon, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354248
- Sponsor's protocol ID
- CHUB-TST01
- Status last verified
- Jan 2018
- First submitted
- 23 Jan 2015
- Last updated
- 23 Jan 2018
- 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 10071055
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Triple Stimulation Technique to Patients With CNS Disorders Including Stroke
- ClinicalTrials.gov ID
- NCT02354248
- Acronym / sponsor ID
- CHUB-TST01
- Conditions
- Stroke Patients
- Keywords
- TST, TMS, Stroke patients, EMG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 11 Jun 2014 (actual)
- Primary completion
- 13 Sep 2016 (actual)
- Study completion
- 13 Sep 2016 (actual)
- First posted
- 3 Feb 2015 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | Experimental | Procedure: Triple stimulation techniqueThe patients will be submitted to a triple stimulation examination. |
| Control Subjects | Active comparator | Procedure: Triple stimulation techniqueThis group of patients did not suffer from a stroke. They will also be submitted to a triple stimulation examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stroke patients with hemiparesia
Key exclusion criteria (3 listed)
- pace maker
- epilepsia
- metallic neurosurgical implants
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 |
|---|---|---|
| Triple stimulation techniqueEvoked 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. | Procedure or surgery | Control Subjects, Stroke patients |
Primary outcome
Amplitude of the motor evoked potentials
Time frame: during the TST (30 min)
Surface 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)
TMS threshold
Time frame: during TST (30 min)
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 23 Jan 2018.
- 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.
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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 Dachy, MD principal investigator
CHU Brugmann
Andrey Bragin, 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 Triple stimulation technique in people with Stroke Patients, 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 1 inclusion and 3 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 23 Jan 2018. 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 5 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 NCT02354248, which also lists 2 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 23 Jan 2018.