Chronic StrokeNCT02881736
Proprioceptive Deficits and Anomalies in Movement-error Processing in Chronic Stroke Patients
A study testing electroencephalographic,magnetic resonance imaging in people with Chronic Stroke, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Clinical assessment of motor and sensory deficits is still today largely based on tests that do not permit any precise quantification. However, robotic technologies, coupled with neuroimaging techniques constitute new tools to assess sensorimotor functions that could allow to conceive neurorehabilitation protocols… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- electroencephalographic,magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Mar 2017
- 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 ischaemia of the upper limb for less than 6 months
- Patients with sensorimotor deficits
Who cannot join
- Patients treated with botulinum toxin for less than 6 months
- Alcoholic patients
- Patients who had surgery on upper limb
Trial locations and contacts
1 site in 1 country.
About this study
Clinical assessment of motor and sensory deficits is still today largely based on tests that do not permit any precise quantification. However, robotic technologies, coupled with neuroimaging techniques constitute new tools to assess sensorimotor functions that could allow to conceive neurorehabilitation protocols better adapted to the neurological impairment of each patient and to her/his specific recovery profile.
The goal of this project is to contribute identifying the factors that determine functional recovery in stroke patients presenting upper-limb motor deficits. Here, we will focus our research on two factors that contribute in a complementary way to motor control: 1) the processing of proprioceptive informations, and 2) the processing of movement-execution errors. In this purpose, we will combine psychophysical methods that allow to precisely quantify sensorimotor deficits with functional and anatomical neuroimaging techniques. More specifically, we will exploit experimental protocols that have been developed in basic research, that use a robotic exoskeleton coupled with a virtual reality device, to precisely quantify motor and proprioceptive deficits in stroke patients. Then, we will link these behavioral data to electroencephalographic (EEG) signals recorded during a motor adaptation task, as well as to anatomical data, namely conventional magnetic resonance imaging (MRI) completed by diffusion tensor images (DTI) in order to achieve a finer description of the cerebral lesions.
Read more
The present study will include two experimental parts, respectively centered on the proprioceptive deficits (Part 1) and the anomalies in the processing of movement-execution errors (Part 2).
Proprioceptive deficits in stroke patients : We will test the hypothesis that, when present, deficits in kinaesthesia and troubles in unconscious proprioception contribute substantially to motor deficits in stroke patients ; with as a corollary hypothesis, that deficits in " proprioception for action " are more determinant than deficits in the conscious sense of position (classically tested in clinics). In this purpose, we will collect three sets of behavioral data, in chronic stroke patients and healthy control participants, respectively intended to assess a) motor deficits, b) troubles in conscious sense of position, and c) deficits in "proprioception for action". To better document the neuronatomical substrates of these different types of deficits. In this purpose, we will link the obtained behavioral data with the results of detailed analyses of the lesions of the tested stroke patients.
Anomalies in the processing of movement-execution errors in stroke patients : We will assess movement-execution error processing in stroke patients, in order to test the idea that anomalies in error processing might contribute to motor deficits in stroke patients. In this purpose, we will record an electrophysiological correlate (ERP) of movement-error processing during a motor adaptation task. We will analyse the relation between the modulation of this ERP and motor performance. We will also examine the relation between these two sets of data (behavioral and electrophysiological) and the behavioral data collected during the first part of the study (Proprioceptive deficits). This will provide us with insight into the relationship between proprioceptive deficits and cinematic error processing. As in the first part of the study, we will link the observed electrophysiological and behavioral anomalies with the results of a detailed analysis of the anatomical lesions of the tested patients.
- Conditions
- Chronic Stroke
- Being tested
- electroencephalographic,magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalographic,magnetic resonance imagingOther
| Study group | Role | What they receive |
|---|---|---|
| Pateint with chronic stroke | Experimental | Not described Receives: Other: electroencephalographic,magnetic resonance imaging |
| Healthy volunteer | Active comparator | Not described Receives: Other: electroencephalographic,magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of anomalies in the processing of movement-execution
Measured: 4hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startOct 2013
- Primary completionMar 2016
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle Desalbres, Study director, Assistance Publique Hôpitaux de MarseilleLaurent Bensoussan, MD/PhD, Principal investigator, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881736
- Sponsor's protocol ID
- 2013-16
- Other IDs
- 2013-A00672-43
- Status last verified
- Aug 2016
- First submitted
- 24 Aug 2016
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprioceptive Deficits and Anomalies in Movement-error Processing in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT02881736
- Acronym / sponsor ID
- 2013-16
- Conditions
- Chronic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2017 (estimated)
- First posted
- 29 Aug 2016 (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.
Clinical assessment of motor and sensory deficits is still today largely based on tests that do not permit any precise quantification. However, robotic technologies, coupled with neuroimaging techniques constitute new tools to assess sensorimotor functions that could allow to conceive neurorehabilitation protocols better adapted to the neurological impairment of each patient and to her/his specific recovery profile.
The goal of this project is to contribute identifying the factors that determine functional recovery in stroke patients presenting upper-limb motor deficits. Here, we will focus our research on two factors that contribute in a complementary way to motor control: 1) the processing of proprioceptive informations, and 2) the processing of movement-execution errors. In this purpose, we will combine psychophysical methods that allow to precisely quantify sensorimotor deficits with functional and anatomical neuroimaging techniques. More specifically, we will exploit experimental protocols that have been developed in basic research, that use a robotic exoskeleton coupled with a virtual reality device, to precisely quantify motor and proprioceptive deficits in stroke patients. Then, we will link these behavioral data to electroencephalographic (EEG) signals recorded during a motor adaptation task, as well as to anatomical data, namely conventional magnetic resonance imaging (MRI) completed by diffusion tensor images (DTI) in order to achieve a finer description of the cerebral lesions.
The present study will include two experimental parts, respectively centered on the proprioceptive deficits (Part 1) and the anomalies in the processing of movement-execution errors (Part 2).
Proprioceptive deficits in stroke patients : We will test the hypothesis that, when present, deficits in kinaesthesia and troubles in unconscious proprioception contribute substantially to motor deficits in stroke patients ; with as a corollary hypothesis, that deficits in " proprioception for action " are more determinant than deficits in the conscious sense of position (classically tested in clinics). In this purpose, we will collect three sets of behavioral data, in chronic stroke patients and healthy control participants, respectively intended to assess a) motor deficits, b) troubles in conscious sense of position, and c) deficits in "proprioception for action". To better document the neuronatomical substrates of these different types of deficits. In this purpose, we will link the obtained behavioral data with the results of detailed analyses of the lesions of the tested stroke patients.
Anomalies in the processing of movement-execution errors in stroke patients : We will assess movement-execution error processing in stroke patients, in order to test the idea that anomalies in error processing might contribute to motor deficits in stroke patients. In this purpose, we will record an electrophysiological correlate (ERP) of movement-error processing during a motor adaptation task. We will analyse the relation between the modulation of this ERP and motor performance. We will also examine the relation between these two sets of data (behavioral and electrophysiological) and the behavioral data collected during the first part of the study (Proprioceptive deficits). This will provide us with insight into the relationship between proprioceptive deficits and cinematic error processing. As in the first part of the study, we will link the observed electrophysiological and behavioral anomalies with the results of a detailed analysis of the anatomical lesions of the tested patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pateint with chronic stroke | Experimental | Other: electroencephalographic,magnetic resonance imaging |
| Healthy volunteer | Active comparator | Other: electroencephalographic,magnetic resonance imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stroke patients with ischaemia of the upper limb for less than 6 months
- Patients with sensorimotor deficits
Key exclusion criteria (3 listed)
- Patients treated with botulinum toxin for less than 6 months
- Alcoholic patients
- Patients who had surgery on upper limb
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 |
|---|---|---|
| electroencephalographic,magnetic resonance imaging | Other | Healthy volunteer, Pateint with chronic stroke |
Primary outcome
Numbers of anomalies in the processing of movement-execution
Time frame: 4hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- 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.
Urielle Desalbres study director
Assistance Publique Hôpitaux de Marseille
Laurent Bensoussan, MD/PhD principal investigator
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroencephalographic,magnetic resonance imaging in people with Chronic Stroke, run by Assistance Publique Hopitaux De Marseille 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 2 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: status not confirmed, as of the sponsor's last update on 29 Aug 2016. 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. 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?
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?
Numbers of anomalies in the processing of movement-execution (time frame: 4hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2016.