No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
22 – 70
Sex
Any
Study type
Interventional
Purpose
Device Feasibility
Participants needed
20 (estimated)
Sponsor
Marco Capogrosso · Other
Who this trial is looking for
This trial is looking for adults who have weakness in their arm and hand due to a stroke that happened at least 6 months ago. Participants will undergo physical therapy and receive a spinal cord implant to help improve their motor control.
Are You a Good Fit for This Trial?
Must not be takingAnti-spasticity medicationsAnti-epileptic medications
Rules you outNeurological conditions other than strokeCancerSevere cardiac diseaseSevere respiratory diseaseRenal failure
You may be able to join if
I had a stroke more than 6 months ago that affected my arm and hand.
I am between 22 and 70 years old.
I can score between 21 and 45 on the upper limb motor test.
I can communicate and follow instructions.
You may not be able to join if
I have a serious disease that affects my participation.
I am at high-risk for another stroke.
I have serious pain or issues in my arm that affect training.
I have severe claustrophobia that stops me from having an MRI.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study plans to use systems that have been developed by Medtronic to investigate the use of cervical spinal cord stimulation to treat adults with upper limb hemiparesis resulting from a stroke. The spinal cord stimulation (SCS) will be combined with physical training to improve arm and hand motor control. The study is divided into three phases. In the first phase, after baseline assessments, p…
This study plans to use systems that have been developed by Medtronic to investigate the use of cervical spinal cord stimulation to treat adults with upper limb hemiparesis resulting from a stroke. The spinal cord stimulation (SCS) will be combined with physical training to improve arm and hand motor control. The study is divided into three phases. In the first phase, after baseline assessments, participants will undergo a Physical Training Protocol (PTP) for 6 weeks including 3 sessions of 90 mins/session per week. After receiving the Medtronic implantable system, in Phase 2, they will then repeat the same PTP program in combination with spinal cord stimulation during the entirety of each of the rehabilitation sessions. Finally, in Phase 3, participants will go home, will not be able to use the stimulation at home but will participate in monthly assessments in the laboratory in which the functionality of the Medtronic system and their motor performances will be assessed for up to 6 months.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Experienced an ischemic or hemorrhagic stroke that resulted in arm and hand hemiparesis more than 6 months prior to the time of enrollment (Prior strokes that did not cause upper extremity motor deficits are not exclusionary.)
2. Age 22 to 70 years old
3. Upper extremity moto…
Inclusion Criteria:
1. Experienced an ischemic or hemorrhagic stroke that resulted in arm and hand hemiparesis more than 6 months prior to the time of enrollment (Prior strokes that did not cause upper extremity motor deficits are not exclusionary.)
2. Age 22 to 70 years old
3. Upper extremity motor score higher than 20 and lower than or equal to 45 on the Fugl-Meyer Assessment (FMA) scale
4. FMA upper extremity sensory score higher than 6 points (out of 12 points)
5. The ability to communicate, understand, give appropriate consent and follow two-step commands
Exclusion Criteria:
1. Presence of any serious disease or disorder (ex. Neurological conditions other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) that could affect their ability to participate in this study
2. Considered to be at high-risk of recurrent stroke as evident from their medical history or upon judgment of the study physician
3. Presence of post-stroke central pain, other forms of pain or other constraints such as joint contractures in the paretic arm that are serious enough to prevent or affect the correct execution of the physical training protocol as judged by the study therapist
4. A score on the Short Blessed Test assessment scale lower than 9
5. Female participants of child-bearing age who are pregnant or breastfeeding during the study
6. Participants that cannot suspend their antiplatelets and/or anticoagulant therapy for two weeks around the time of surgery
7. Existence of any implanted medical device that is not MRI safe and/or any active medical devices even if it is MRI safe
8. Implanted spinal fusion and stabilization devices such as plates and rods between the C2 and T3 spinal vertebra
9. Obstructed or restricted epidural spinal canal to the point of hindering or increasing the risk of implant of the spinal leads as judged by the study surgeon upon screening imaging
10. Severe claustrophobia that prevents execution of the required MRI imaging sessions
11. Taking anti-spasticity or anti-epileptic medications
12. T-score higher than 63 on the 18-question Brief Symptoms Inventory (BSI-18) who have undergone discussions with and been deemed unsuitable by the Principal Investigator and a study physician
Potential participants who may be excluded on initial screening may discuss possible medication changes with their physician.
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