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出境医 / 临床实验 / Repetitive Nerve Stimulation to Improve Recovery After Stroke (RESTORES)
Repetitive Nerve Stimulation to Improve Recovery After Stroke (RESTORES)
Study Description
Brief Summary:
Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral electrical stimulation (RPES) is a novel strategy to improve upper limb motor performance in the post-stroke chronic phase but its effects in the subacute phase are still poorly understood. The objectives of this study are to compare the effects of RPES on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke | Device: Repetitive peripheral nerve stimulation | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 72 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison Between Mechanisms Underlying Effects of Repetitive Peripheral Nerve Stimulation on Upper Limb Motor Performance in the Subacute and Chronic Phases After Stroke |
| Actual Study Start Date : | December 1, 2019 |
| Estimated Primary Completion Date : | October 30, 2021 |
| Estimated Study Completion Date : | October 30, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Active, subacute stroke
Repetitive peripheral electrical stimulation (RPES) + Motor Training. Active RPES will be administered for 2 hours. After active session of RPES, the patient will receive motor training.
|
Device: Repetitive peripheral nerve stimulation
Active repetitive peripheral nerve stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For active stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required.
|
|
Sham Comparator: Sham, subacute stroke
Sham Comparator: Sham + Motor Training. Sham will be administered for 2 hours. After sham, the patient will receive motor training
|
Device: Repetitive peripheral nerve stimulation
Active repetitive peripheral nerve stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For active stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required.
|
|
Active Comparator: Active, chronic stroke
Repetitive peripheral electrical stimulation (RPES) + Motor Training. Active RPES will be administered for 2 hours. After active session of RPES, the patient will receive motor training.
|
Device: Repetitive peripheral nerve stimulation
Active repetitive peripheral nerve stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For active stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required.
|
|
Sham Comparator: Sham, chronic stroke
Sham Comparator: Sham + Motor Training. Sham will be administered for 2 hours. After sham, the patient will receive motor training
|
Device: Repetitive peripheral nerve stimulation
Active repetitive peripheral nerve stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For active stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required.
|
Outcome Measures
Primary Outcome Measures :
- Change in Jebsen-Taylor Test [ Time Frame: Immediately after one session of intervention ]Test of upper limb dexterity
Secondary Outcome Measures :
- Change in lateral pinch strength [ Time Frame: Immediately after one session of intervention ]Pinch strength measured with dynamometer
- Change in gamma-aminobutyric acid levels in primary motor cortex [ Time Frame: Immediately after one session of intervention ]Gamma-aminobutyric acid levels measured with magnetic resonance imaging spectroscopy
- Change in brain perfusion [ Time Frame: Immediately after one session of intervention ]Brain perfusion measured with magnetic resonance imaging - arterial spin labeling
- Change in grasp strength [ Time Frame: Immediately after one session of intervention ]Grasp strength measured with dynamometer
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ischemic or hemorrhagic stroke confirmed by computed tomography or magnetic resonance imaging, between 7 days - 3 months before enrollment (subacute phase), and at least 6 months (chronic phase).
- Ability to perform at least 4 of 7 tasks performed in daily life that is part of the Jebsen-Taylor Test
Exclusion Criteria:
- Anesthesia of the paretic hand.
- Lesions affecting the motor cortex (hand area).
- Lesions affecting cerebellum, or cerebellar pathways in the brainstem.
- Severe spasticity at the paretic elbow, fist or fingers, defined with a score larger than 3 on the Modified Ashworth Scale.
- Neurological diseases such as Parkinson disease or chronic uncontrolled chronic disease such as cancer or cardiac insufficiency.
- Elbow pain or join deformity in the paretic limb.
- Pregnancy.
- Uncontrolled psychiatric disease.
- Aphasia or severe cognitive deficit.
- Inability to provide consent.
- Inability to attend the experimental sessions.
Contacts and Locations
Contacts
| Contact: Adriana Conforto | +55-11-21519542 | adrianabc@einstein.br | |
| Contact: Larissa Servinsckins | +55-11-21513354 | larissa.servinsckins@einstein.br |
Locations
| Brazil | |
| Hospital São Rafael | Recruiting |
| Salvador, BA, Brazil, 41253-190 | |
| Contact: Suzete N da Guarda, Prof +55-71-3409-8000 suzetefariasdaguarda@icloud.com | |
| Hospital Israelita Albert Einstein | Recruiting |
| São Paulo, SP, Brazil, 05.652-000 | |
| Contact: Adriana B Conforto, Prof +55-11-21519542 adriana.conforto@einstein.br | |
| Contact: Jesica B Kroth, PT +55-11-21519542 jessicakroth@hotmail.com | |
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Fundação de Amparo à Pesquisa do Estado de São Paulo
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 16, 2019 | ||||||||
| First Posted Date ICMJE | May 20, 2019 | ||||||||
| Last Update Posted Date | August 7, 2020 | ||||||||
| Actual Study Start Date ICMJE | December 1, 2019 | ||||||||
| Estimated Primary Completion Date | October 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in Jebsen-Taylor Test [ Time Frame: Immediately after one session of intervention ] Test of upper limb dexterity
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Repetitive Nerve Stimulation to Improve Recovery After Stroke | ||||||||
| Official Title ICMJE | Comparison Between Mechanisms Underlying Effects of Repetitive Peripheral Nerve Stimulation on Upper Limb Motor Performance in the Subacute and Chronic Phases After Stroke | ||||||||
| Brief Summary | Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral electrical stimulation (RPES) is a novel strategy to improve upper limb motor performance in the post-stroke chronic phase but its effects in the subacute phase are still poorly understood. The objectives of this study are to compare the effects of RPES on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Stroke | ||||||||
| Intervention ICMJE | Device: Repetitive peripheral nerve stimulation
Active repetitive peripheral nerve stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For active stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
72 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | October 30, 2022 | ||||||||
| Estimated Primary Completion Date | October 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Brazil | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03956407 | ||||||||
| Other Study ID Numbers ICMJE | 3019629 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Hospital Israelita Albert Einstein | ||||||||
| Study Sponsor ICMJE | Hospital Israelita Albert Einstein | ||||||||
| Collaborators ICMJE | Fundação de Amparo à Pesquisa do Estado de São Paulo | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Hospital Israelita Albert Einstein | ||||||||
| Verification Date | July 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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