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New treatment option for Stroke
Official title Pilot Study: Home Use of Wearable Grasping Neuroprosthesis in Vascular Hemiparesis
ClinicalTrials.gov ID: NCT07500480
What this study is testing
- What it's testing
- Stroke is the leading cause of acquired motor disability in adults. Six months post-stroke, 50% of patients have not regained active finger extension, and 80% retain a grasping deficit, most commonly an inability to actively open the hand.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patient who participated in and completed the GRASP-AGAIN study and achieved functional improvement through the use of NAP.
- Motor deficit of an upper limb resulting from a single ischemic or hemorrhagic stroke, hemispheric or brainstem, confirmed by brain imaging (CT scan...
- Brain lesion occurring more than one month prior;
- Presence of at least one of the following two disabilities:
- Inability to actively extend the long fingers (open the hand) to actively grasp an empty glass (upper and lower diameters of 7 and 6 cm respectively...
You likely can't join if
- The person is in labor or breastfeeding;
- The person is pregnant, the diagnosis being guided by questioning (date of last menstrual period, desire for pregnancy, contraception) and possibly...
- Musculotendinous contractures or joint stiffness of the fingers and wrist preventing passive opening of the fingers;
- Limited approach ability preventing the hand from being positioned in front of the abdomen (without contact) at the level of the midline sagittal...
- Paretic pain in the upper limb limiting the performance of the standardized grasping task;
- Major sensory disturbances corresponding to a Somatosensation subscore of the modified Erasmus Nottingham Sensory Assessment French version (EmNSA-F...
See the full eligibility criteria
Who can join
- Adult patient who participated in and completed the GRASP-AGAIN study and achieved functional improvement through the use of NAP.
- Motor deficit of an upper limb resulting from a single ischemic or hemorrhagic stroke, hemispheric or brainstem, confirmed by brain imaging (CT scan or MRI);
- Brain lesion occurring more than one month prior;
- Presence of at least one of the following two disabilities:
- Inability to actively extend the long fingers (open the hand) to actively grasp an empty glass (upper and lower diameters of 7 and 6 cm respectively, height of 12 to 15 cm, weight of 125 g, identical to the material...
- Inability to actively extend the thumb to grasp the handle of a soup spoon (flat, like a key) without the aid of the other hand, using a thumb-index finger pulp-lateral grip (grasping task in the Wolf Motor Function...
- Patient receiving care within the standard healthcare pathway;
- Ability to sit in a chair and remain focused for at least 1.5 hours;
- Free, informed, and written consent signed by the participant and the investigator (no later than the day of enrollment and before any examination required for the research);
- Individual affiliated with or covered by a social security scheme
What rules you out
- The person is in labor or breastfeeding;
- The person is pregnant, the diagnosis being guided by questioning (date of last menstrual period, desire for pregnancy, contraception) and possibly confirmed by a blood test for beta hCG;
- Musculotendinous contractures or joint stiffness of the fingers and wrist preventing passive opening of the fingers;
- Limited approach ability preventing the hand from being positioned in front of the abdomen (without contact) at the level of the midline sagittal plane, while the subject is seated;
- Paretic pain in the upper limb limiting the performance of the standardized grasping task;
- Major sensory disturbances corresponding to a Somatosensation subscore of the modified Erasmus Nottingham Sensory Assessment French version (EmNSA-F, see Appendix A) upper limb \<10/44;
- Severe aphasia with a Boston Diagnostic Severity Aphasia Examination Severity Scale score ≤ 3, see Appendix B, indicating that there may be a marked decrease in verbal fluency or ease and rapidity of comprehension...
- Known gestural apraxia, within the limits of the subject's motor abilities (ideomotor apraxia, ideational apraxia, dressing apraxia, or reflexive apraxia);
- Unilateral spatial neglect demonstrated with the bell test (see Appendix B'), if the difference between omissions in the left and right visual fields is greater than or equal to 6;
- The extensor digitorum communis and/or extensor pollicis longus muscles cannot be stimulated with the neuroprosthesis, meaning that sufficient extension of the long fingers and/or thumb for grasping tasks is not...
- The person has a pacemaker;
- Presence of uncontrolled epilepsy;
- Presence of unstable cardiovascular disease (coronary artery disease, severe hypertension, heart failure);
- Presence of a dermatological condition contraindicating the application of surface electrodes;
- The person is participating in another research study with an ongoing exclusion period;
- The person is under legal guardianship or conservatorship;
- The person refuses to sign the consent form;
- It proves impossible to provide the person with informed consent and ensure their compliance due to impaired physical and/or psychological health.
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.