StrokePhase 1NCT00860210
Pilot Study Assessing the Feasibility of Treating Foot Drop With the Neurostep™ System.
A Phase 1 study testing Neurostep™ System in people with Stroke and Craniocerebral Trauma, run by Neurostream Technologies G.P. at 4 sites in 3 countries.
Trial summary
This pilot feasibility study is assessing the safety and technical performance of the Neurostep™ System for the restoration of independent gait in subjects with gait disorder (i.e. foot drop) secondary to a CNS lesion (e.g. stroke). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Craniocerebral Trauma
- What is being tested?
- Neurostep™ System
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Oct 2007to Mar 2010
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with a unilateral gait disorder as a result of a specified CNS lesion (e.g., stroke)with stable neurological deficit for at least 6 months
- Medically stable, able to and agree to undergo a surgery
- Able to stand and walk at least 5 meters
- Agree to attend frequent study scheduled visits
- Able to provide verbal or written feedback
- Have provided written informed consent
- Have intact tibial and common peroneal nerves
Who cannot join
- Pregnant or nursing women
- Medically insufficiently stable to undergo surgery
- Poor range of motion of affected ankle or fixed ankle
- Foreseen need for Magnetic Resonance Imaging (MRI)
- Significant mental or psychiatric impairment
- Cannot understand or provide signed informed consent
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- Cannot provide verbal or written feedback
- Have been implanted with a pacemaker or other active medical device
- Must continuously take anticoagulants
- Uncontrolled heart or cardiovascular-related disease conditions
- Have been diagnosed with muscle atrophy and/or peripheral polyneuropathy
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Canada2 sites
CHA- Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4
VCHA G. F. Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
United Kingdom1 site
Southampton General Hospital
Southampton, Southampton, SO16 6YD
About this study
Official title: Pilot Feasibility Study of the Neurostep™ System in Subjects With Gait Disorder Secondary to CNS Lesion.
This pilot feasibility study is assessing the safety and technical performance of the Neurostep™ System for the restoration of independent gait in subjects with gait disorder (i.e. foot drop) secondary to a CNS lesion (e.g. stroke).
Read the detailed description
The Neurostep™ System is a neurostimulation investigational medical device. The entire system is designed to be implanted into the subject's leg via a surgical procedure, during which electrodes are attached to the peripheral nerves responsible for sensing and stimulating the proper muscles that lift the foot during normal walking.
- Conditions
- Stroke, Craniocerebral Trauma
- Being tested
- Neurostep™ System
- Medical subject headings
- Stroke, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurostep™ SystemDevice
Also called Neurostep
The Neurostep™ System is a neurostimulation investigational medical device. The entire system is designed to be implanted into the subject's leg via a surgical procedure, during which electrodes are attached to the peripheral nerves responsible for sensing and stimulating the proper muscles that lift the foot during normal walking.
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological integrity of the nerves surrounded by the nerve cuffs assessed using Nerve Conduction Velocity (NCV) tests. Status Quo in physical examinations of the subject.
Measured: Throughout the study period (23 weeks)
Secondary outcomes (1)
Ability to stimulate the common peroneal nerve and selectively activate ankle dorsiflexor muscles to produce symmetrical motion of the foot. Ability to sense the heel-strike and toe-lift events during walking.
Measured: From the surgical implantation to the end of the study (i.e. 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startOct 2007
- Primary completionNov 2009
- Study completionMar 2010
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurostream Technologies G.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pankaj Dhawan, Principal investigator, VCHA G. F. Strong Rehabilitation CentreMichel Prud'homme, Principal investigator, CHA- Hôpital de l'Enfant-JésusAnn Ashburn, Principal investigator, University Hospital Southampton NHS Foundation TrustSandeep Vaishya, Principal investigator, Max Superspeciality Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860210
- Sponsor's protocol ID
- VHB-PFS-NSS III
- Other IDs
- VHB-PFS-NSS III-SS01-PRT, VHB-PFS-NSS III-SS02-PRT, VHB-PFS-NSS III-SS03-PRT, VHB-PFS-NSS III-SS04-PRT
- Status last verified
- Apr 2010
- First submitted
- 11 Mar 2009
- Last updated
- 12 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of the Neurostep™ System in Subjects With Gait Disorder Secondary to CNS Lesion.
- ClinicalTrials.gov ID
- NCT00860210
- Acronym / sponsor ID
- VHB-PFS-NSS III
- Conditions
- Stroke, Craniocerebral Trauma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Neurostream Technologies G.P.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 12 Mar 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.
This pilot feasibility study is assessing the safety and technical performance of the Neurostep™ System for the restoration of independent gait in subjects with gait disorder (i.e. foot drop) secondary to a CNS lesion (e.g. stroke).
Detailed description
The Neurostep™ System is a neurostimulation investigational medical device. The entire system is designed to be implanted into the subject's leg via a surgical procedure, during which electrodes are attached to the peripheral nerves responsible for sensing and stimulating the proper muscles that lift the foot during normal walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with a unilateral gait disorder as a result of a specified CNS lesion (e.g., stroke)with stable neurological deficit for at least 6 months
- Medically stable, able to and agree to undergo a surgery
- Able to stand and walk at least 5 meters
- Agree to attend frequent study scheduled visits
- Able to provide verbal or written feedback
Key exclusion criteria (11 listed)
- Pregnant or nursing women
- Medically insufficiently stable to undergo surgery
- Poor range of motion of affected ankle or fixed ankle
- Foreseen need for Magnetic Resonance Imaging (MRI)
- Significant mental or psychiatric impairment
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 |
|---|---|---|
| Neurostep™ SystemAlso: NeurostepThe Neurostep™ System is a neurostimulation investigational medical device. The entire system is designed to be implanted into the subject's leg via a surgical procedure, during which electrodes are attached to the peripheral nerves responsible for sensing and stimulating the proper muscles that lift the foot during normal walking. | Device | – |
Primary outcome
Electrophysiological integrity of the nerves surrounded by the nerve cuffs assessed using Nerve Conduction Velocity (NCV) tests. Status Quo in physical examinations of the subject.
Time frame: Throughout the study period (23 weeks)
1 secondary outcome
Ability to stimulate the common peroneal nerve and selectively activate ankle dorsiflexor muscles to produce symmetrical motion of the foot. Ability to sense the heel-strike and toe-lift events during walking.
Time frame: From the surgical implantation to the end of the study (i.e. 20 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 12 Apr 2010.
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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.
Pankaj Dhawan principal investigator
VCHA G. F. Strong Rehabilitation Centre
Michel Prud'homme principal investigator
CHA- Hôpital de l'Enfant-Jésus
Ann Ashburn principal investigator
University Hospital Southampton NHS Foundation Trust
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neurostep™ System in people with Stroke and Craniocerebral Trauma, run by Neurostream Technologies G.P. at 4 sites in 3 countries.
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 7 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 12 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, India, United Kingdom. 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.
What does this 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.
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?
Electrophysiological integrity of the nerves surrounded by the nerve cuffs assessed using Nerve Conduction Velocity (NCV) tests. Status Quo in physical examinations of the subject. (time frame: Throughout the study period (23 weeks)). 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 12 Apr 2010.