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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3NS123135-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
The main goal for this study is to evaluate safety of the Medtronic system in the stroke population. The second goal of this study is to assess and document the effects of SCS on motor control. More specifically, whether the combination of SCS and physical exercise (PTP+SCS) will improve motor control and reduce impairments, with the goal of optimizing inclusion criteria and outcome measures for future efficacy studies. To achieve this goal, we designed a study based on the rationale that the ramp up PTP phase 1 will bring people to a plateau motor impairment, in consequence any improvement upon this plateaued level should be due to the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Therapy Alone, then Combined with Spinal Cord Stimulation | Experimental | Two percutaneous leads will be implanted unilaterally on the affected side in the epidural space of the C3-T1 vertebrae (Medtronic Vectrisâ„¢ SureScanâ„¢ 1x8). The leads will be connected to an external stimulator (Medtronic Inceptivâ„¢ spinal cord neurostimulation system) during research activities. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulator (Medtronic Inceptivâ„¢ System) | Device | The Medtronic Inceptivâ„¢ spinal cord neurostimulation system is a rechargeable implantable pulse generator (IPG) designed to deliver electrical pulses to the spinal cord via implanted leads. The system is intended for use in patients with chronic pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Severity of Adverse Events | Success Criteria: no serious adverse events related to the stimulation or intolerable. adverse events reported | From enrollment to the end of treatment at 49 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Impairment - Post Implant to end of Phase 2 | The investigators will measure the change in Fugl Meyer (FM) score from post-implant to the end of Phase 2 with SCS ON. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The upper extremity motor function score ranges from 0 to 66 points. Success criteria: mean change FM across Phase 2 is greater than zero, indicating an additional therapeutic benefit of SCS beyond physical training executed in Phase 1 . |
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Inclusion Criteria:
Exclusion Criteria:
Potential participants who may be excluded on initial screening may discuss possible medication changes with their physician.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Boos, MS | Contact | 412-648-4179 | amy.boos@pitt.edu | |
| Cierra Clark, MS | Contact | 240-441-4216 | cic27@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| George Wittenberg, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
All of the individual participant data collected during the trial, after deidentification, may be shared with other researchers for the purpose of data analysis and collaboration.
Data will become available at the end of the trial upon publication of the first manuscript. Estimation is 2 years from enrollment of first participant.
Data must be directly requested to the PI and will be shared upon completion of necessary data sharing agreement to protect confidential patient information.
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Single-center, interventional, open-label, non-randomized, single-arm feasibility study to obtain initial evidence of safety and efficacy of using spinal cord stimulation (SCS) in combination with physical therapy.
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| Physical Therapy | Other | The physical therapy intervention consists of two components: the Mind-Pod Dolphin system (targeting arm function) and the Hummingbird Hunt system (targeting hand function). Both systems use interactive gaming software that enables participants to engage in remote, game-based therapy. Each system offers multiple difficulty levels, allowing participants to progress as their skills improve. |
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| Post implant to the end of Phase 2 (11 weeks) |
| Motor Impairment - Absolute Change | The investigators will measure the change in Fugl Meyer (FM) score from the baseline to the end of Phase 2 with SCS OFF. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The upper extremity motor function score ranges from 0 to 66 points. Success criteria: mean change FM across the study period is greater than 5, indicating the average improvement surpasses the minimal clinically meaningful threshold. | Baseline to the end of Phase 2 (19 weeks) |
| Spasticity - Phase 2 | The investigators will quantify spasticity scores using the Modified Ashworth Scale (MAS) which is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0-4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch. The investigators will measure the change in MAS score across phase 2. The test is executed with SCS OFF. Success criteria: mean change MAS across Phase 2 is greater than 0. This would show that SCS is able to reduce spasticity beyond the Phase 1 physical training. | Phase 2 (7 weeks) |
| Spasticity - Absolute Change | The investigators will quantify spasticity scores using the Modified Ashworth Scale (MAS) which is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0-4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch. The investigators will measure the change in MAS score from the baseline to the end of Phase 2. The test is executed with SCS OFF. Success criteria: mean change MAS across the study is greater or equal than 2 points, indicating that average reduction surpasses the minimal clinically meaningful threshold. | Baseline to the end of Phase 2 (19 weeks) |
| Strength - Phase 2 | The investigators will measure changes in isometric torque produced during maximal voluntary contractions across shoulder, elbow and grip strength with SCS ON and SCS OFF. Success criteria: 75% of the participants have significantly higher maximal torques (or forces) with SCS ON compared to SCS OFF in at least 1 movement of at least 1 joint. (e.g. elbow extension). This will confirm that SCS can immediately improve strength. | Phase 2 (7 weeks) |
| Motor Control - Phase 2 and 3 | The investigators will perform FM testing within a 2-day period with SCS OFF and SCS ON. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. The upper extremity motor function score ranges from 0 to 66 points, with a higher score indicating a better outcome. Success criteria: 75% of the participants have higher FM scores with SCS ON compared to SCS OFF of at least 3 points. | Phase 2 through Phase 3 (31 weeks) |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D013119 | Spinal Cord Injuries |
| D004194 | Disease |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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