StrokeNCT02658578
Peripheral Nerve Stimulation and Motor Training in Stroke
A study testing PNS in people with Stroke, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilitation interventions represents a major challenge to global health care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- PNS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to Mar 2021
- 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
- Age, 18 years or older;
- Ischemic or hemorrhagic stroke at least six months before, confirmed by computed tomography or magnetic resonance imaging;
- Moderate to severe motor impairment of an upper limb, defined as a score between 7 and 50 on the Fugl-Meyer Assessment of Sensorimotor Recovery after stroke, a scale with scores for upper limb ranging from 0 (no function) to 66 (normal function);
- Ability to provide written Informed Consent (patient or legal representative);
- Ability to comply with the schedule of interventions and evaluations in the protocol.
Who cannot join
- Lack of ability to voluntarily activate any active range of wrist extension;
- Anesthesia of the paretic hand;
- Severe spasticity at the paretic elbow, wrist, or fingers, defined as a score of >3 on the Modified Ashworth Spasticity Scale;
- Active joint deformity;
- Uncontrolled medical problems such as end-stage cancer or renal disease;
- Pregnancy;
Show all 13Show fewer
- Seizures, if current use of drugs that may decrease seizure threshold such as tryciclic antidepressants;
- Pacemakers;
- Other neurological disorders such as Parkinson's disease;
- Psychiatric illness including severe depression;
- Aphasia or serious cognitive deficits that preclude comprehension of the experimental protocol or ability to provide consent;
- Treatment of upper limb spasticity with botulinum toxin within the past three months.
- Lesions that affect the cerebellum or cerebelar/vestibular pathways in the brainstem
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/Fundação Faculdade de Medicina
São Paulo, São Paulo, 05403000
About this study
Official title: Peripheral Nerve Stimulation and Motor Training to Enhance Hand Function After Stroke
Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilitation interventions represents a major challenge to global health care. Upper limb weakness is frequent after stroke, but there is no universally accepted treatment to effectively improve hand function in patients with moderate and severe motor impairment. These are the patients in deepest need of rehabilitative interventions. This project addresses this important issue, by testing effects of a novel approach. The investigators will non-invasively stimulate peripheral nerves in order to enhance effects of motor training aided by an electrical stimulation device in patients with moderate to severe hand weakness. Our hypothesis is that peripheral nerve stimulation will enhance effects of motor training in patients in the chronic stage after stroke.
Read the detailed description
The objective of this protocol is to determine whether a neuromodulation intervention associated with functional electrical stimulation, when combined with task-specific training over several sessions, decreases upper limb motor disability, motor impairment, overall disability and improves quality of life compared to the sham intervention and functional electrical stimulation.
The interventions will consist of three sessions per week, over six weeks, of outpatient functional electrical stimulation of the paretic wrist and task-specific training. In each session, either active peripheral nerve stimulation (PNS) or sham PNS will be applied. Before the first session, patients will be familiarized with the procedures.
- Conditions
- Stroke
- Being tested
- PNS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNSProcedure or surgery
Also called Peripheral Nerve Stimulation
Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator. In sham PNS, the median, ulnar and radial nerves will not be actively stimulated.
| Study group | Role | What they receive |
|---|---|---|
| Active PNS | Active comparator | Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator. Receives: Procedure: PNS |
| Sham PNS | Placebo comparator | In sham PNS, the median, ulnar and radial nerves will not be actively stimulated. Receives: Procedure: PNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
The primary outcome will be evaluated before the intervention and 6 weeks after the beginning of the intervention.
Measured: 6 weeks
Secondary outcomes (13)
Motor Activity Log
This questionnaire will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Measured: 18 weeks
Active range of motion of wrist extension in the paretic side
This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Measured: 18 weeks
Active range of motion of wrist flexion in the paretic side
This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Measured: 18 weeks
Grasp force in the paretic side
This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Measured: 18 weeks
Grip force in the paretic side
This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Measured: 18 weeks
Fugl-Meyer Assessment of Sensorimotor Recovery
This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Measured: 18 weeks
Barthel Index
This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Measured: 18 weeks
Stroke Impact Scale
This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Measured: 18 weeks
Beck Depression Inventory-short Form
This questionnaire will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
Measured: 18 weeks
Wolf Motor Function Test
This scale as a secondary outcome will be evaluated before the intervention and 3, 10 and 18 weeks after the beginning of the intervention.
Measured: 18 weeks
Modified Ashworth Scale
This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks
Measured: 18 weeks
Minimal Clinically Important Difference - Wolf Motor Function Test - time
This outcome will be evaluated at 6, 10 and 18 weeks
Measured: 18 weeks
Minimal Clinically Important Difference - Wolf Motor Function Test - Functional Ability Scale
This outcome will be evaluated at 6, 10 and 18 weeks
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2020
- Study completionMar 2021
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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação Faculdade de Medicina, National Institute of Neurological Disorders and Stroke (NINDS), The Cleveland Clinic
- Responsible party
- Principal investigator, Adriana Bastos Conforto, University of Sao Paulo General Hospital
- Investigators
- Adriana Conforto, MD PhD, Principal investigator, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/ Fundação Faculdade de Medicina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658578
- Sponsor's protocol ID
- 0546/2011
- Other IDs
- R01NS076348
- Status last verified
- Nov 2020
- First submitted
- 29 Dec 2015
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Conforto AB, Machado AG, Ribeiro NHV, Plow EB, Liew SL, da Costa Leite C, Zavaliangos-Petropulu A, Menezes I, Dos Anjos SM, Luccas R, Peckham PH, Cohen LG. Repetitive Peripheral Sensory Stimulation as an Add-On Intervention for Upper Limb Rehabilitation in Stroke: A Randomized Trial. Neurorehabil Neural Repair. 2021 Dec;35(12):1059-1064. doi: 10.1177/15459683211046259. Epub 2021 Sep 29.
PubMed 34587830Conforto AB, Machado AG, Menezes I, Ribeiro NHV, Luccas R, Pires DS, Leite CDC, Plow EB, Cohen LG. Treatment of Upper Limb Paresis With Repetitive Peripheral Nerve Sensory Stimulation and Motor Training: Study Protocol for a Randomized Controlled Trial. Front Neurol. 2020 Mar 25;11:196. doi: 10.3389/fneur.2020.00196. eCollection 2020.
PubMed 32269549
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Stimulation and Motor Training to Enhance Hand Function After Stroke
- ClinicalTrials.gov ID
- NCT02658578
- Acronym / sponsor ID
- 0546/2011
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação Faculdade de Medicina, National Institute of Neurological Disorders and Stroke (NINDS), The Cleveland Clinic
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 20 Jan 2016 (estimated)
- 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.
Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilitation interventions represents a major challenge to global health care. Upper limb weakness is frequent after stroke, but there is no universally accepted treatment to effectively improve hand function in patients with moderate and severe motor impairment. These are the patients in deepest need of rehabilitative interventions. This project addresses this important issue, by testing effects of a novel approach. The investigators will non-invasively stimulate peripheral nerves in order to enhance effects of motor training aided by an electrical stimulation device in patients with moderate to severe hand weakness. Our hypothesis is that peripheral nerve stimulation will enhance effects of motor training in patients in the chronic stage after stroke.
Detailed description
The objective of this protocol is to determine whether a neuromodulation intervention associated with functional electrical stimulation, when combined with task-specific training over several sessions, decreases upper limb motor disability, motor impairment, overall disability and improves quality of life compared to the sham intervention and functional electrical stimulation.
The interventions will consist of three sessions per week, over six weeks, of outpatient functional electrical stimulation of the paretic wrist and task-specific training. In each session, either active peripheral nerve stimulation (PNS) or sham PNS will be applied. Before the first session, patients will be familiarized with the procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PNS | Active comparator | Procedure: PNSActive PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator. |
| Sham PNS | Placebo comparator | Procedure: PNSIn sham PNS, the median, ulnar and radial nerves will not be actively stimulated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age, 18 years or older;
- Ischemic or hemorrhagic stroke at least six months before, confirmed by computed tomography or magnetic resonance imaging;
- Moderate to severe motor impairment of an upper limb, defined as a score between 7 and 50 on the Fugl-Meyer Assessment of Sensorimotor Recovery after stroke, a scale with scores for upper limb ranging from 0 (no function) to 66 (normal function);
- Ability to provide written Informed Consent (patient or legal representative);
- Ability to comply with the schedule of interventions and evaluations in the protocol.
Key exclusion criteria (13 listed)
- Lack of ability to voluntarily activate any active range of wrist extension;
- Anesthesia of the paretic hand;
- Severe spasticity at the paretic elbow, wrist, or fingers, defined as a score of >3 on the Modified Ashworth Spasticity Scale;
- Active joint deformity;
- Uncontrolled medical problems such as end-stage cancer or renal disease;
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 |
|---|---|---|
| PNSAlso: Peripheral Nerve StimulationActive PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator. In sham PNS, the median, ulnar and radial nerves will not be actively stimulated. | Procedure or surgery | Active PNS, Sham PNS |
Primary outcome
Wolf Motor Function Test
Time frame: 6 weeks
The primary outcome will be evaluated before the intervention and 6 weeks after the beginning of the intervention.
13 secondary outcomes
Motor Activity Log
Time frame: 18 weeks
Active range of motion of wrist extension in the paretic side
Time frame: 18 weeks
Active range of motion of wrist flexion in the paretic side
Time frame: 18 weeks
Grasp force in the paretic side
Time frame: 18 weeks
Grip force in the paretic side
Time frame: 18 weeks
Fugl-Meyer Assessment of Sensorimotor Recovery
Time frame: 18 weeks
Barthel Index
Time frame: 18 weeks
Stroke Impact Scale
Time frame: 18 weeks
Beck Depression Inventory-short Form
Time frame: 18 weeks
Wolf Motor Function Test
Time frame: 18 weeks
Modified Ashworth Scale
Time frame: 18 weeks
Minimal Clinically Important Difference - Wolf Motor Function Test - time
Time frame: 18 weeks
Minimal Clinically Important Difference - Wolf Motor Function Test - Functional Ability Scale
Time frame: 18 weeks
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 22 Jul 2021.
- Derived from this study: PubMed 34587830Conforto AB, Machado AG, Ribeiro NHV, Plow EB, Liew SL, da Costa Leite C, Zavaliangos-Petropulu A, Menezes I, Dos Anjos SM, Luccas R, Peckham PH, Cohen LG. Repetitive Peripheral Sensory Stimulation as an Add-On Intervention for Upper Limb Rehabilitation in Stroke: A Randomized Trial. Neurorehabil Neural Repair. 2021 Dec;35(12):1059-1064. doi: 10.1177/15459683211046259. Epub 2021 Sep 29.
- Derived from this study: PubMed 32269549Conforto AB, Machado AG, Menezes I, Ribeiro NHV, Luccas R, Pires DS, Leite CDC, Plow EB, Cohen LG. Treatment of Upper Limb Paresis With Repetitive Peripheral Nerve Sensory Stimulation and Motor Training: Study Protocol for a Randomized Controlled Trial. Front Neurol. 2020 Mar 25;11:196. doi: 10.3389/fneur.2020.00196. eCollection 2020.
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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.
Adriana Conforto, MD PhD principal investigator
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/ Fundação Faculdade de Medicina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNS in people with Stroke, run by University of Sao Paulo General Hospital 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 5 inclusion and 13 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 22 Jul 2021. 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. Some participants in this study may receive a placebo. 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?
Wolf Motor Function Test (time frame: 6 weeks). 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 NCT02658578, 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 22 Jul 2021.