Stroke/Brain AttackVIBRAMOTNCT04504214
Tendon Vibrations Effect on Upper Limb Motor Recovery After Recent Stroke
A study testing Upper limb repeated multi-site tendon vibrations in people with Stroke/Brain Attack and Upper Extremity Paresis, run by Centre Borelli UMR 9010 at 1 site in France.
Trial summary
Stroke is the leading cause of severe acquired disabilities in adults. It can affect sensory and motor functions which are closely entangled. Among them, upper limb function is often strongly impaired. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke/Brain Attack, Upper Extremity Paresis
- What is being tested?
- Upper limb repeated multi-site tendon vibrations
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2015to 31 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1st ischemic or hemorrhagic stroke
- Motor deficit of the upper limb (Fugl-Meyer between 0 and 50)
- Delay since stroke <or = 60 days
- Subject having given free and informed consent
- Subject affiliated to the social security system
Who cannot join
- Neurological history responsible for sensory or motor impairment of the concerned upper limb
- Surgical history concerning the nervous or locomotor system of the concerned upper limb
- Uncontrolled epilepsy
- Pace-maker
- Ferro-magnetic intra-cranial clip and any other contraindication to MEP and MRI
- Cochlear implants
- Pregnancy
- Guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
Marylène JOUSSE, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Physical and Rehabilitation Medicine department of Hôpital Fernand Widal
Paris, Île-de-France Region, 75010
Emna JELILI, engineer, +33 (0) 1 40 05 49 46, emna.jelili@aphp.fr
Marylène JOUSSE, MD, PhD, marylene.jousse@aphp.fr
About this study
Official title: A Pilot Study of Proprioception Stimulation by Repeated Multi-site Tendon Vibrations, on Upper Limb Motor Skills Recovery After Recent Stroke
Stroke is the leading cause of severe acquired disabilities in adults. It can affect sensory and motor functions which are closely entangled. Among them, upper limb function is often strongly impaired. In this study the investigators are interested in the eventuality to improve motor recovery by the mean of stimulating the proprioception.
Proprioception can be stimulated by tendinous vibrations in order to act on the neuromuscular system through the vibratory tonic reflex and by movement illusion.
Stimulation by tendinous vibrations, applied to the musculotendinous endings, has been already proposed in post stroke rehabilitation, but only at late stages. Thus the aim of our study is to observe the effects of repeated tendon vibrations, applied in the early post stroke phase, the effect being measured on the excitability of the motor cortex by the Motor Evoked Potentials and on the motor recovery (motor control and activities).
Read the detailed description
Stroke is the leading cause of severe acquired disabilities in adults. It can affect sensory and motor functions which are closely entangled. Among them, upper limb function is often strongly impaired. In this study the investigators are interested in the eventuality to improve motor recovery by the mean of stimulating the proprioception.
Proprioception can be stimulated by tendinous vibrations in order to act on the neuromuscular system through the vibratory tonic reflex and by movement illusion.
Stimulation by tendinous vibrations, applied to the musculotendinous endings, has been already proposed in post stroke rehabilitation, but only at late stages.
Thus the aim of our study is to observe the effects of repeated tendon vibrations, applied in the early post stroke phase, the effect being measured on the excitability of the motor cortex by the Motor Evoked Potentials and on the motor recovery (motor control and activities).
Patients: 30 patients recruited after a first ever stroke whatever the cause and the site; age >18; stroke delay< 60 days; the maximum duration of participation for each patient is 3 months.
Protocol:
This rehabilitation protocol will be added to the usual rehabilitation program during inpatient rehabilitation.
Participants are randomized into two groups: experimental group and placebo group.
The experimental group benefits from upper limb tendon vibration sessions produced by small electromechanical vibrators on the elbow and the wrist. Frequency of the vibration is 80 Hz, two 15-minutes sessions per day scheduled for 10 days over a period of two weeks (2 x 5 days). During the sessions, the participant wearing opaque glasses, in a seating position, is asked to move if possible his/her arm in the opposite direction of the perceived movement.
The placebo group receives apparently the same treatment but with "sham" vibration.
Assessment:
Motor recovery will be assessed:
- At the brain level by the efficiency of the primary motor pathway, measured by Motor Evoked Potentials recorded at the contralateral hand (main outcome criteria after 30 days from inclusion).
- At the limb level by the motor control effectiveness measured by the Fugl Meyer scale, the Tardieu scale, the Action Research Arm Test (ARAT), the Box and Blocks Test (BBT) and the range of upper limb exploration with the ArmeoSpring, Hocoma brand.
The secondary objectives are:
- To assess any impact on nerve fibers density on the main motor pathway by Magnetic Resonance Imaging.
- To test the feasibility of such a rehabilitation protocol in a Physical Rehabilitation Medicine department
Four consultations are planned:
D0 (day 0): (before starting stimulation): Motor skills assessments, Motor Evoked Potentials (MEP) and Magnetic Resonance Imaging (MRI).
D15 (day 15): (as soon as stimulation ends): Motor skills assessments. D30 (day 30): Motor skills assessments and Motor Evoked Potentials (MEP) D90 (day 90): Motor skills assessments, Motor Evoked Potentials (MEP) and Magnetic Resonance Imaging (MRI).
- Conditions
- Stroke/Brain Attack, Upper Extremity Paresis
- Being tested
- Upper limb repeated multi-site tendon vibrations
- Keywords
- stroke, rehabilitation, proprioception
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper limb repeated multi-site tendon vibrationsOther
Upper limb tendon vibration protocol will be added to the usual rehabilitation protocol performed during hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (EG) | Experimental | An Experimental Group (EG) of post-stroke subjects having vibration stimulation sessions in addition to traditional rehabilitation Receives: Other: Upper limb repeated multi-site tendon vibrations |
| Control Group (CG) | Sham comparator | A Control Group (WG) of post-stroke subjects having placebo/sham vibration sessions (same vibrators used but without the eccentric mass), in addition to traditional rehabilitation Receives: Other: Upper limb repeated multi-site tendon vibrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor recovery assessment at the brain level by the efficiency of the primary motor pathway measured by Motor Evoked Potentials (MEP) recorded at the contralateral hand
Assessment of Motor recovery at the brain level by the efficiency of the primary motor pathway, measured by Motor Evoked Potentials (MEP) recorded at the contralateral hand:
Magnetic stimulation is provided on the motor cortex involved by the stroke. The MEP are recorded on the contralateral side on the hand interossei muscles, in a bandwidth of 20 to 1000 Hz.
The electromyographic activity is recorded continuously to ensure total relaxation of the patient before stimulation.
The main parameter recorded is:
the threshold defined by the minimum stimulation intensity capable of generating a MEP> 50 microvolts amplitude in at least 3 of 6 tests, while the muscle is fully relaxed. Same measurements are made after moderate contraction of the collecting muscles (finger spacing).
Measured: 30 day after the first assessment session (D30)
Secondary outcomes (3)
Motor recovery assessment at the upper limb level
Motor control effectiveness is measured by the Fugl Meyer scale, the Tardieu scale, the Action Research Arm Test (ARAT), the Box and Blocks Test (BBT) and the range of upper limb exploration with the ArmeoSpring (Hocoma)
Measured: at inclusion (first assessment, D0), 15 days after inclusion (as soon as stimulations ends, D15), 30 days after inclusion (D30), 90 days after inclusion (D90)
To assess any impact on nerve fibers density on the main motor pathway by Magnetic Resonance Imaging
The MRI is used to assess the possible impact of vibrations on nerve fibers density of the main motor pathway (corticospinal bundle).
Diffusion tensor and tractography sequences are used to outline the direction and the density of nerve fibers. The corticospinal tract is particularly highlighted The first MRI takes place before any stimulation. It is used to localize the stroke in relation to the corticospinal tracts and to measure its volume.
A first tractography is used to assess the initial disorganization of the fiber bundles.
A 3D analysis of the tractography allows a visual assessment of the number and the density of fibers compared to the normal side.
A second MRI will be conducted after 3 months with same method of tractography analysis.
Measured: at inclusion (first assessment, D0), 90 days after inclusion (D90)
To test the feasibility of such a rehabilitation protocol in a PMR department
To study the impact of the protocol on the organization and rehabilitation if it proved useful to usual care.
The feasibility will be achieved by recording:
Total daily duration of installation and stimulation Technical difficulties encountered
Measured: After inclusions completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Oct 2015
- Primary completion1 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Stroke/Brain AttackStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilot, prospective, biomedical, randomized, controlled study with intent-to-treat analysis of a stroke subjects cohort
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Borelli UMR 9010
- Sponsor type
- Research network
- Collaborators
- Hopital Lariboisière
- Responsible party
- Principal investigator, Alain YELNIK, Centre Borelli UMR 9010
- Investigators
- Alain YELNIK, MD, Prof, Study director, Centre BORELLI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504214
- Sponsor's protocol ID
- 015-A00559-40
- Acronym
- VIBRAMOT
- Status last verified
- Aug 2020
- First submitted
- 5 Aug 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reinkensmeyer DJ, Boninger ML. Technologies and combination therapies for enhancing movement training for people with a disability. J Neuroeng Rehabil. 2012 Mar 30;9:17. doi: 10.1186/1743-0003-9-17.
PubMed 22463132Kitago T, Krakauer JW. Motor learning principles for neurorehabilitation. Handb Clin Neurol. 2013;110:93-103. doi: 10.1016/B978-0-444-52901-5.00008-3.
PubMed 23312633Nudo RJ, McNeal D. Plasticity of cerebral functions. Handb Clin Neurol. 2013;110:13-21. doi: 10.1016/B978-0-444-52901-5.00002-2.
PubMed 23312627Edin BB, Johansson N. Skin strain patterns provide kinaesthetic information to the human central nervous system. J Physiol. 1995 Aug 15;487(1):243-51. doi: 10.1113/jphysiol.1995.sp020875.
PubMed 7473253Hagbarth KE, Eklund G. The muscle vibrator--a useful tool in neurological therapeutic work. Scand J Rehabil Med. 1969;1(1):26-34. No abstract available.
PubMed 5406721Goodwin GM, McCloskey DI, Matthews PB. Proprioceptive illusions induced by muscle vibration: contribution by muscle spindles to perception? Science. 1972 Mar 24;175(4028):1382-4. doi: 10.1126/science.175.4028.1382.
PubMed 4258209Roll JP, Vedel JP. Kinaesthetic role of muscle afferents in man, studied by tendon vibration and microneurography. Exp Brain Res. 1982;47(2):177-90. doi: 10.1007/BF00239377.
PubMed 6214420Roll JP, Albert F, Thyrion C, Ribot-Ciscar E, Bergenheim M, Mattei B. Inducing any virtual two-dimensional movement in humans by applying muscle tendon vibration. J Neurophysiol. 2009 Feb;101(2):816-23. doi: 10.1152/jn.91075.2008. Epub 2008 Dec 3.
PubMed 19052107Heath CJ, Hore J, Phillips CG. Inputs from low threshold muscle and cutaneous afferents of hand and forearm to areas 3a and 3b of baboon's cerebral cortex. J Physiol. 1976 May;257(1):199-227. doi: 10.1113/jphysiol.1976.sp011364.
PubMed 820853Forner-Cordero A, Steyvers M, Levin O, Alaerts K, Swinnen SP. Changes in corticomotor excitability following prolonged muscle tendon vibration. Behav Brain Res. 2008 Jun 26;190(1):41-9. doi: 10.1016/j.bbr.2008.02.019. Epub 2008 Feb 20.
PubMed 18378327Marconi B, Filippi GM, Koch G, Pecchioli C, Salerno S, Don R, Camerota F, Saraceni VM, Caltagirone C. Long-term effects on motor cortical excitability induced by repeated muscle vibration during contraction in healthy subjects. J Neurol Sci. 2008 Dec 15;275(1-2):51-9. doi: 10.1016/j.jns.2008.07.025. Epub 2008 Aug 29.
PubMed 18760809Rosenkranz K, Rothwell JC. The effect of sensory input and attention on the sensorimotor organization of the hand area of the human motor cortex. J Physiol. 2004 Nov 15;561(Pt 1):307-20. doi: 10.1113/jphysiol.2004.069328. Epub 2004 Sep 23.
PubMed 15388776Noma T, Matsumoto S, Shimodozono M, Etoh S, Kawahira K. Anti-spastic effects of the direct application of vibratory stimuli to the spastic muscles of hemiplegic limbs in post-stroke patients: a proof-of-principle study. J Rehabil Med. 2012 Apr;44(4):325-30. doi: 10.2340/16501977-0946.
PubMed 22402727Celnik P, Hummel F, Harris-Love M, Wolk R, Cohen LG. Somatosensory stimulation enhances the effects of training functional hand tasks in patients with chronic stroke. Arch Phys Med Rehabil. 2007 Nov;88(11):1369-76. doi: 10.1016/j.apmr.2007.08.001.
PubMed 17964875Liepert J, Binder C. Vibration-induced effects in stroke patients with spastic hemiparesis--a pilot study. Restor Neurol Neurosci. 2010;28(6):729-35. doi: 10.3233/RNN-2010-0541.
PubMed 21209488
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Proprioception Stimulation by Repeated Multi-site Tendon Vibrations, on Upper Limb Motor Skills Recovery After Recent Stroke
- ClinicalTrials.gov ID
- NCT04504214
- Acronym / sponsor ID
- VIBRAMOT / 015-A00559-40
- Conditions
- Stroke/Brain Attack, Upper Extremity Paresis
- Keywords
- stroke, rehabilitation, proprioception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Borelli UMR 9010Research network
- Collaborators
- Hopital Lariboisière
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Aug 2020 (actual)
- 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.
Stroke is the leading cause of severe acquired disabilities in adults. It can affect sensory and motor functions which are closely entangled. Among them, upper limb function is often strongly impaired. In this study the investigators are interested in the eventuality to improve motor recovery by the mean of stimulating the proprioception.
Proprioception can be stimulated by tendinous vibrations in order to act on the neuromuscular system through the vibratory tonic reflex and by movement illusion.
Stimulation by tendinous vibrations, applied to the musculotendinous endings, has been already proposed in post stroke rehabilitation, but only at late stages. Thus the aim of our study is to observe the effects of repeated tendon vibrations, applied in the early post stroke phase, the effect being measured on the excitability of the motor cortex by the Motor Evoked Potentials and on the motor recovery (motor control and activities).
Detailed description
Stroke is the leading cause of severe acquired disabilities in adults. It can affect sensory and motor functions which are closely entangled. Among them, upper limb function is often strongly impaired. In this study the investigators are interested in the eventuality to improve motor recovery by the mean of stimulating the proprioception.
Proprioception can be stimulated by tendinous vibrations in order to act on the neuromuscular system through the vibratory tonic reflex and by movement illusion.
Stimulation by tendinous vibrations, applied to the musculotendinous endings, has been already proposed in post stroke rehabilitation, but only at late stages.
Thus the aim of our study is to observe the effects of repeated tendon vibrations, applied in the early post stroke phase, the effect being measured on the excitability of the motor cortex by the Motor Evoked Potentials and on the motor recovery (motor control and activities).
Patients: 30 patients recruited after a first ever stroke whatever the cause and the site; age >18; stroke delay< 60 days; the maximum duration of participation for each patient is 3 months.
Protocol:
This rehabilitation protocol will be added to the usual rehabilitation program during inpatient rehabilitation.
Participants are randomized into two groups: experimental group and placebo group.
The experimental group benefits from upper limb tendon vibration sessions produced by small electromechanical vibrators on the elbow and the wrist. Frequency of the vibration is 80 Hz, two 15-minutes sessions per day scheduled for 10 days over a period of two weeks (2 x 5 days). During the sessions, the participant wearing opaque glasses, in a seating position, is asked to move if possible his/her arm in the opposite direction of the perceived movement.
The placebo group receives apparently the same treatment but with "sham" vibration.
Assessment:
Motor recovery will be assessed:
- At the brain level by the efficiency of the primary motor pathway, measured by Motor Evoked Potentials recorded at the contralateral hand (main outcome criteria after 30 days from inclusion).
- At the limb level by the motor control effectiveness measured by the Fugl Meyer scale, the Tardieu scale, the Action Research Arm Test (ARAT), the Box and Blocks Test (BBT) and the range of upper limb exploration with the ArmeoSpring, Hocoma brand.
The secondary objectives are:
- To assess any impact on nerve fibers density on the main motor pathway by Magnetic Resonance Imaging.
- To test the feasibility of such a rehabilitation protocol in a Physical Rehabilitation Medicine department
Four consultations are planned:
D0 (day 0): (before starting stimulation): Motor skills assessments, Motor Evoked Potentials (MEP) and Magnetic Resonance Imaging (MRI).
D15 (day 15): (as soon as stimulation ends): Motor skills assessments. D30 (day 30): Motor skills assessments and Motor Evoked Potentials (MEP) D90 (day 90): Motor skills assessments, Motor Evoked Potentials (MEP) and Magnetic Resonance Imaging (MRI).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- pilot, prospective, biomedical, randomized, controlled study with intent-to-treat analysis of a stroke subjects cohort
| Arm | Type | Receives |
|---|---|---|
| Experimental group (EG) | Experimental | Other: Upper limb repeated multi-site tendon vibrationsAn Experimental Group (EG) of post-stroke subjects having vibration stimulation sessions in addition to traditional rehabilitation |
| Control Group (CG) | Sham comparator | Other: Upper limb repeated multi-site tendon vibrationsA Control Group (WG) of post-stroke subjects having placebo/sham vibration sessions (same vibrators used but without the eccentric mass), in addition to traditional rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1st ischemic or hemorrhagic stroke
- Motor deficit of the upper limb (Fugl-Meyer between 0 and 50)
- Delay since stroke <or = 60 days
- Subject having given free and informed consent
- Subject affiliated to the social security system
Key exclusion criteria (8 listed)
- Neurological history responsible for sensory or motor impairment of the concerned upper limb
- Surgical history concerning the nervous or locomotor system of the concerned upper limb
- Uncontrolled epilepsy
- Pace-maker
- Ferro-magnetic intra-cranial clip and any other contraindication to MEP and MRI
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 |
|---|---|---|
| Upper limb repeated multi-site tendon vibrationsUpper limb tendon vibration protocol will be added to the usual rehabilitation protocol performed during hospitalization | Other | Control Group (CG), Experimental group (EG) |
Primary outcome
Motor recovery assessment at the brain level by the efficiency of the primary motor pathway measured by Motor Evoked Potentials (MEP) recorded at the contralateral hand
Time frame: 30 day after the first assessment session (D30)
Assessment of Motor recovery at the brain level by the efficiency of the primary motor pathway, measured by Motor Evoked Potentials (MEP) recorded at the contralateral hand: Magnetic stimulation is provided on the motor cortex involved by the stroke. The MEP are recorded on the contralateral side on the hand interossei muscles, in a bandwidth of 20 to 1000 Hz. The electromyographic activity is recorded continuously to ensure total relaxation of the patient before stimulation. The main parameter recorded is: the threshold defined by the minimum stimulation intensity capable of generating a MEP> 50 microvolts amplitude in at least 3 of 6 tests, while the muscle is fully relaxed. Same measurements are made after moderate contraction of the collecting muscles (finger spacing).
3 secondary outcomes
Motor recovery assessment at the upper limb level
Time frame: at inclusion (first assessment, D0), 15 days after inclusion (as soon as stimulations ends, D15), 30 days after inclusion (D30), 90 days after inclusion (D90)
To assess any impact on nerve fibers density on the main motor pathway by Magnetic Resonance Imaging
Time frame: at inclusion (first assessment, D0), 90 days after inclusion (D90)
To test the feasibility of such a rehabilitation protocol in a PMR department
Time frame: After inclusions completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Results publication: PubMed 22463132Reinkensmeyer DJ, Boninger ML. Technologies and combination therapies for enhancing movement training for people with a disability. J Neuroeng Rehabil. 2012 Mar 30;9:17. doi: 10.1186/1743-0003-9-17.
- Results publication: PubMed 23312633Kitago T, Krakauer JW. Motor learning principles for neurorehabilitation. Handb Clin Neurol. 2013;110:93-103. doi: 10.1016/B978-0-444-52901-5.00008-3.
- Results publication: PubMed 23312627Nudo RJ, McNeal D. Plasticity of cerebral functions. Handb Clin Neurol. 2013;110:13-21. doi: 10.1016/B978-0-444-52901-5.00002-2.
- Results publication: PubMed 7473253Edin BB, Johansson N. Skin strain patterns provide kinaesthetic information to the human central nervous system. J Physiol. 1995 Aug 15;487(1):243-51. doi: 10.1113/jphysiol.1995.sp020875.
- Results publication: PubMed 5406721Hagbarth KE, Eklund G. The muscle vibrator--a useful tool in neurological therapeutic work. Scand J Rehabil Med. 1969;1(1):26-34. No abstract available.
- Results publication: PubMed 4258209Goodwin GM, McCloskey DI, Matthews PB. Proprioceptive illusions induced by muscle vibration: contribution by muscle spindles to perception? Science. 1972 Mar 24;175(4028):1382-4. doi: 10.1126/science.175.4028.1382.
- Results publication: PubMed 6214420Roll JP, Vedel JP. Kinaesthetic role of muscle afferents in man, studied by tendon vibration and microneurography. Exp Brain Res. 1982;47(2):177-90. doi: 10.1007/BF00239377.
- Results publication: PubMed 19052107Roll JP, Albert F, Thyrion C, Ribot-Ciscar E, Bergenheim M, Mattei B. Inducing any virtual two-dimensional movement in humans by applying muscle tendon vibration. J Neurophysiol. 2009 Feb;101(2):816-23. doi: 10.1152/jn.91075.2008. Epub 2008 Dec 3.
- Results publication: PubMed 820853Heath CJ, Hore J, Phillips CG. Inputs from low threshold muscle and cutaneous afferents of hand and forearm to areas 3a and 3b of baboon's cerebral cortex. J Physiol. 1976 May;257(1):199-227. doi: 10.1113/jphysiol.1976.sp011364.
- Results publication: PubMed 18378327Forner-Cordero A, Steyvers M, Levin O, Alaerts K, Swinnen SP. Changes in corticomotor excitability following prolonged muscle tendon vibration. Behav Brain Res. 2008 Jun 26;190(1):41-9. doi: 10.1016/j.bbr.2008.02.019. Epub 2008 Feb 20.
- Results publication: PubMed 18760809Marconi B, Filippi GM, Koch G, Pecchioli C, Salerno S, Don R, Camerota F, Saraceni VM, Caltagirone C. Long-term effects on motor cortical excitability induced by repeated muscle vibration during contraction in healthy subjects. J Neurol Sci. 2008 Dec 15;275(1-2):51-9. doi: 10.1016/j.jns.2008.07.025. Epub 2008 Aug 29.
- Results publication: PubMed 15388776Rosenkranz K, Rothwell JC. The effect of sensory input and attention on the sensorimotor organization of the hand area of the human motor cortex. J Physiol. 2004 Nov 15;561(Pt 1):307-20. doi: 10.1113/jphysiol.2004.069328. Epub 2004 Sep 23.
- epidemiological stroke data in FranceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Marylène JOUSSE, MD, PhD contact
Alain YELNIK, MD, Prof study director
Centre BORELLI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper limb repeated multi-site tendon vibrations in people with Stroke/Brain Attack and Upper Extremity Paresis, run by Centre Borelli UMR 9010 at 1 site in France.
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 8 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: status not confirmed, as of the sponsor's last update on 11 Aug 2020. 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 France. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emna JELILI, engineer (+33 (0) 1 40 05 49 46, emna.jelili@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor recovery assessment at the brain level by the efficiency of the primary motor pathway measured by Motor Evoked Potentials (MEP) recorded at the contralateral hand (time frame: 30 day after the first assessment session (D30)). 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 NCT04504214, which also lists 24 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 11 Aug 2020.