StrokePhase 1/2NCT01034150
Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
A Phase 1/2 study testing Relief band (Somatosensory stimulation) in people with Stroke, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Objective: To investigate effects of home-based somatosensory stimulation associated with motor training on improvement in performance of the paretic upper extremity in patients in the chronic phase after stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Relief band (Somatosensory stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2007to Nov 2009
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-80 years;
- single ischemic or hemorrhagic stroke in a cerebral hemisphere, documented by computed tomography (CT) or magnetic resonance imaging (MRI);
- stroke onset at least six months before;
- hand paresis with preserved ability to perform all tasks of the Jebsen-Taylor Test (JTT).
Who cannot join
- previous strokes;
- epilepsy and other neurological conditions;
- proprioceptive or tactile anesthesia;
- shoulder or hand pain;
- severe joint deformity;
- severe chronic disease;
- inability to give provide informed consent due to severe aphasia or cognitive impairment;
- left handedness before the stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To investigate effects of home-based somatosensory stimulation associated with motor training on improvement in performance of the paretic upper extremity in patients in the chronic phase after stroke.
Read the detailed description
Design: Double-blind, randomized, controlled clinical trial. Setting: Home-based rehabilitation. Subjects: Patients in the chronic phase (> 6 months) after stroke. Interventions: Patients will be randomized to an active and a control group. In both groups, treatments will be performed at home, daily, over four weeks. Patients in the active group will be instructed to use a device that provides somatosensory stimulation in the form of electrical stimulation of the median nerve for two hours. Patients in the control group will also be instructed to use the device for two hours, and sham stimulation will be administered. In both groups, patients will be instructed to train activities with the paretic hand immediately after nerve stimulation.
Main measures: The primary outcome will be improvement in performance of the paretic hand evaluated by the Jebsen-Taylor test at end of treatment and four months after end of treatment, compared to baseline. Secondary outcomes were: 1) Compliance with the interventions, assessed through a daily written log, and oral reports of the patients; 2) safety profile of the interventions.
- Conditions
- Stroke
- Being tested
- Relief band (Somatosensory stimulation), Placebo stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relief band (Somatosensory stimulation)Device
Also called Relief band
Electrical median nerve stimulation
Placebo stimulationDevice
Also called no stimulation
Placebo stimulation
| Study group | Role | What they receive |
|---|---|---|
| Somatosensory stimulation | Active comparator | Active group Receives: Device: Relief band (Somatosensory stimulation) |
| Control group | Placebo comparator | Placebo stimulation Receives: Device: Placebo stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the improvement in upper extremity performance assessed using Jebsen-Taylor test
Measured: Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment
Secondary outcomes (2)
Compliance with the interventions, assessed through a daily written log, and oral reports of the patients
Measured: immediately after the treatment
Adverse events
Measured: at end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startDec 2007
- Primary completionSep 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Adriana Conforto, MD PhD, Principal investigator, Hospital das Clínicas/FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034150
- Sponsor's protocol ID
- 1309-06
- Other IDs
- 477916/06-6
- Status last verified
- Nov 2009
- First submitted
- 11 Dec 2009
- Last updated
- 17 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT01034150
- Acronym / sponsor ID
- 1309-06
- Conditions
- Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Dec 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 17 Dec 2009 (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.
Objective: To investigate effects of home-based somatosensory stimulation associated with motor training on improvement in performance of the paretic upper extremity in patients in the chronic phase after stroke.
Detailed description
Design: Double-blind, randomized, controlled clinical trial. Setting: Home-based rehabilitation. Subjects: Patients in the chronic phase (> 6 months) after stroke. Interventions: Patients will be randomized to an active and a control group. In both groups, treatments will be performed at home, daily, over four weeks. Patients in the active group will be instructed to use a device that provides somatosensory stimulation in the form of electrical stimulation of the median nerve for two hours. Patients in the control group will also be instructed to use the device for two hours, and sham stimulation will be administered. In both groups, patients will be instructed to train activities with the paretic hand immediately after nerve stimulation.
Main measures: The primary outcome will be improvement in performance of the paretic hand evaluated by the Jebsen-Taylor test at end of treatment and four months after end of treatment, compared to baseline. Secondary outcomes were: 1) Compliance with the interventions, assessed through a daily written log, and oral reports of the patients; 2) safety profile of the interventions.
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 |
|---|---|---|
| Somatosensory stimulation | Active comparator | Device: Relief band (Somatosensory stimulation)Active group |
| Control group | Placebo comparator | Device: Placebo stimulationPlacebo stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-80 years;
- single ischemic or hemorrhagic stroke in a cerebral hemisphere, documented by computed tomography (CT) or magnetic resonance imaging (MRI);
- stroke onset at least six months before;
- hand paresis with preserved ability to perform all tasks of the Jebsen-Taylor Test (JTT).
Key exclusion criteria (8 listed)
- previous strokes;
- epilepsy and other neurological conditions;
- proprioceptive or tactile anesthesia;
- shoulder or hand pain;
- severe joint deformity;
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 |
|---|---|---|
| Relief band (Somatosensory stimulation)Also: Relief bandElectrical median nerve stimulation | Device | Somatosensory stimulation |
| Placebo stimulationAlso: no stimulationPlacebo stimulation | Device | Control group |
Primary outcome
the improvement in upper extremity performance assessed using Jebsen-Taylor test
Time frame: Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment
2 secondary outcomes
Compliance with the interventions, assessed through a daily written log, and oral reports of the patients
Time frame: immediately after the treatment
Adverse events
Time frame: at end of treatment
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 17 Dec 2009.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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/FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Relief band (Somatosensory stimulation) 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 4 inclusion and 8 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 17 Dec 2009. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the improvement in upper extremity performance assessed using Jebsen-Taylor test (time frame: Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2009.