StrokeRESTORESNCT03956407
Repetitive Nerve Stimulation to Improve Recovery After Stroke
A study testing Suprathreshold repetitive peripheral sensory stimulation and Subthreshold repetitive sensory stimulation in people with Stroke, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral sensory stimulation (RPSS) 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Suprathreshold repetitive peripheral sensory stimulation and Subthreshold repetitive sensory stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2019to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- Pregnancy.
- Uncontrolled psychiatric disease.
- Aphasia or severe cognitive deficit.
- Inability to provide consent.
- Inability to attend the experimental sessions.
Trial locations and contacts
1 site in 1 country.
About this study
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
Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral sensory stimulation (RPSS) 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 RPSS on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention.
- Conditions
- Stroke
- Being tested
- Suprathreshold repetitive peripheral sensory stimulation, Subthreshold repetitive sensory stimulation
- Keywords
- Rehabilitation, Neuromodulation, Peripheral stimulation, Motor function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprathreshold repetitive peripheral sensory stimulationDevice
Suprathreshold repetitive peripheral sensory 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 suprathreshold stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required.
Subthreshold repetitive sensory stimulationDevice
Subthreshold repetitive sensory 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 subthreshold stimulation, intensities will be set at 10mv - 15mv lower than de lowest intensity able to induce sensory paraesthesias, and adjusted if required.
| Study group | Role | What they receive |
|---|---|---|
| Suprathreshold, subacute stroke | Experimental | Repetitive peripheral sensory stimulation (RPSS) + Motor Training. Suprathreshold RPSS will be administered for 2 hours. After RPES, the patient will receive motor training. Receives: Device: Suprathreshold repetitive peripheral sensory stimulation |
| Subthreshold, subacute stroke | Other | Other: Subthreshold RPSS + Motor Training. Subthreshold RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training Receives: Device: Subthreshold repetitive sensory stimulation |
| Suprathreshold, chronic stroke | Experimental | Repetitive peripheral sensory stimulation (RPSS) + Motor Training. Suprathreshold RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training. Receives: Device: Suprathreshold repetitive peripheral sensory stimulation |
| Subthreshold, chronic stroke | Other | Other: Subthreshold RPSS + Motor Training. RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training Receives: Device: Subthreshold repetitive sensory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Jebsen-Taylor Test
Test of upper limb dexterity
Measured: Immediately after one session of intervention
Secondary outcomes (4)
Change in lateral pinch strength
Pinch strength measured with dynamometer
Measured: Immediately after one session of intervention
Change in gamma-aminobutyric acid levels in primary motor cortex
Gamma-aminobutyric acid levels measured with magnetic resonance imaging spectroscopy
Measured: Immediately after one session of intervention
Change in brain perfusion
Brain perfusion measured with magnetic resonance imaging - arterial spin labeling
Measured: Immediately after one session of intervention
Change in grasp strength
Grasp strength measured with dynamometer
Measured: Immediately after one session of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start1 Dec 2019
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956407
- Sponsor's protocol ID
- 3019629
- Acronym
- RESTORES
- Status last verified
- Feb 2025
- First submitted
- 16 May 2019
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Conforto AB, Neto RMA, Handfas B, Teixeira V, Zaiden J, Santos IO, Gava T, Pouza K, Reis SB, Silva GS, Amaro E Jr, da Guarda SNF. Divergent Effects of Repetitive Peripheral Stimulation in Subacute and Chronic Stroke: Results From the RESTORES Proof-of-Principle Randomized Trial. Neurorehabil Neural Repair. 2026 Jul;40(7):523-536. doi: 10.1177/15459683261426351. Epub 2026 Mar 30.
PubMed 41911266Kroth JB, Handfas B, Rodrigues G, Zepeda F, Oliveira MA, Wang DJJ, de Azevedo Neto RM, Silva GS, Amaro E Jr, Sorinola IO, Conforto AB. Effects of Repetitive Peripheral Sensory Stimulation in the Subacute and Chronic Phases After Stroke: Study Protocol for a Pilot Randomized Trial. Front Neurol. 2022 Feb 16;13:779128. doi: 10.3389/fneur.2022.779128. eCollection 2022.
PubMed 35250807
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03956407
- Acronym / sponsor ID
- RESTORES / 3019629
- Conditions
- Stroke
- Keywords
- Rehabilitation, Neuromodulation, Peripheral stimulation, Motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral sensory stimulation (RPSS) 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 RPSS on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Suprathreshold, subacute stroke | Experimental | Device: Suprathreshold repetitive peripheral sensory stimulationRepetitive peripheral sensory stimulation (RPSS) + Motor Training. Suprathreshold RPSS will be administered for 2 hours. After RPES, the patient will receive motor training. |
| Subthreshold, subacute stroke | Other | Device: Subthreshold repetitive sensory stimulationOther: Subthreshold RPSS + Motor Training. Subthreshold RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training |
| Suprathreshold, chronic stroke | Experimental | Device: Suprathreshold repetitive peripheral sensory stimulationRepetitive peripheral sensory stimulation (RPSS) + Motor Training. Suprathreshold RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training. |
| Subthreshold, chronic stroke | Other | Device: Subthreshold repetitive sensory stimulationOther: Subthreshold RPSS + Motor Training. RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprathreshold repetitive peripheral sensory stimulationSuprathreshold repetitive peripheral sensory 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 suprathreshold stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required. | Device | Suprathreshold, chronic stroke, Suprathreshold, subacute stroke |
| Subthreshold repetitive sensory stimulationSubthreshold repetitive sensory 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 subthreshold stimulation, intensities will be set at 10mv - 15mv lower than de lowest intensity able to induce sensory paraesthesias, and adjusted if required. | Device | Subthreshold, chronic stroke, Subthreshold, subacute stroke |
Primary outcome
Change in Jebsen-Taylor Test
Time frame: Immediately after one session of intervention
Test of upper limb dexterity
4 secondary outcomes
Change in lateral pinch strength
Time frame: Immediately after one session of intervention
Change in gamma-aminobutyric acid levels in primary motor cortex
Time frame: Immediately after one session of intervention
Change in brain perfusion
Time frame: Immediately after one session of intervention
Change in grasp strength
Time frame: Immediately after one session of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Derived from this study: PubMed 41911266Conforto AB, Neto RMA, Handfas B, Teixeira V, Zaiden J, Santos IO, Gava T, Pouza K, Reis SB, Silva GS, Amaro E Jr, da Guarda SNF. Divergent Effects of Repetitive Peripheral Stimulation in Subacute and Chronic Stroke: Results From the RESTORES Proof-of-Principle Randomized Trial. Neurorehabil Neural Repair. 2026 Jul;40(7):523-536. doi: 10.1177/15459683261426351. Epub 2026 Mar 30.
- Derived from this study: PubMed 35250807Kroth JB, Handfas B, Rodrigues G, Zepeda F, Oliveira MA, Wang DJJ, de Azevedo Neto RM, Silva GS, Amaro E Jr, Sorinola IO, Conforto AB. Effects of Repetitive Peripheral Sensory Stimulation in the Subacute and Chronic Phases After Stroke: Study Protocol for a Pilot Randomized Trial. Front Neurol. 2022 Feb 16;13:779128. doi: 10.3389/fneur.2022.779128. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprathreshold repetitive peripheral sensory stimulation and Subthreshold repetitive sensory stimulation in people with Stroke, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Jebsen-Taylor Test (time frame: Immediately after one session of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03956407, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.