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New treatment option for Stroke
Official title Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis
ClinicalTrials.gov ID: NCT07153536
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- Experienced an ischemic or hemorrhagic stroke that resulted in arm and hand hemiparesis more than 6 months prior to the time of enrollment (Prior...
- Age 22 to 70 years old
- Upper extremity motor score higher than 20 and lower than or equal to 45 on the Fugl-Meyer Assessment (FMA) scale
- FMA upper extremity sensory score higher than 6 points (out of 12 points)
- The ability to communicate, understand, give appropriate consent and follow two-step commands
You likely can't join if
- Presence of any serious disease or disorder (ex. Neurological conditions other than stroke, cancer, severe cardiac or respiratory disease, renal...
- Considered to be at high-risk of recurrent stroke as evident from their medical history or upon judgment of the study physician
- 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...
- A score on the Short Blessed Test assessment scale lower than 9
- Female participants of child-bearing age who are pregnant or breastfeeding during the study
- Participants that cannot suspend their antiplatelets and/or anticoagulant therapy for two weeks around the time of surgery
See the full eligibility criteria
- 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...
- Age 22 to 70 years old
- Upper extremity motor score higher than 20 and lower than or equal to 45 on the Fugl-Meyer Assessment (FMA) scale
- FMA upper extremity sensory score higher than 6 points (out of 12 points)
- The ability to communicate, understand, give appropriate consent and follow two-step commands
- 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
- Considered to be at high-risk of recurrent stroke as evident from their medical history or upon judgment of the study physician
- 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...
- A score on the Short Blessed Test assessment scale lower than 9
- Female participants of child-bearing age who are pregnant or breastfeeding during the study
- Participants that cannot suspend their antiplatelets and/or anticoagulant therapy for two weeks around the time of surgery
- Existence of any implanted medical device that is not MRI safe and/or any active medical devices even if it is MRI safe
- Implanted spinal fusion and stabilization devices such as plates and rods between the C2 and T3 spinal vertebra
- 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
- Severe claustrophobia that prevents execution of the required MRI imaging sessions
- Taking anti-spasticity or anti-epileptic medications
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
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 study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. 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.