HemiparesisNCT01640041
Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators
A study testing Radio-frequency Microstiumulator in people with Hemiparesis, run by The Alfred E. Mann Foundation for Scientific Research at 1 site in United States.
Trial summary
The purpose of this study is to test an innovative, advanced FNS microstimulator technology developed by the Alfred Mann Foundation (Santa Clarita, CA) called, the Radio Frequency Microstimulation (RFM) Gait System that promises to provide FNS training for restoration of functional gait components in a manner at least… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hemiparesis
- What is being tested?
- Radio-frequency Microstiumulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jan 2010
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cognition intact to give valid informed consent to participate.
- Sufficient endurance to participate in rehabilitation sessions.
- Ability to follow 2 stage commands, in English.
- Medically stable.
- Age > 21 years.
- Impaired ambulation as follows: inability to flex the knee and ankle in the sagittal plane, in a normal manner so the foot clears the floor, inability to control normal knee angle during single limb weight bearing during stance phase .
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- Minimum trace (Manual Muscle Test score of 1) contraction of hip, knee, and ankle flexors and extensors under volitional control.
- Passive range of motion at hip, knee, ankle normal gait kinematics.
- Five degrees (5°) of motion for knee and ankle flexors and extensors produced by muscle stimulation achieved non-invasively with electrical stimulation applied to the skin surface.
- At least 12 months post stroke.
- Ability to understand the informed consent form in English.
- Thigh and lower leg circumference and length ≤ 50th percentile of standard U.S. population morphology measures.*
- Participants should be able to walk and keep balance without physical assistance
- Response to Surface Stimulation at a trace for tibialis anterior and peronous longus.
- Subject with unilateral defects
Who cannot join
- Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.
- Active psychiatric diagnosis or psychological condition, or active drug/alcohol abuse.
- Lower motor neuron damage or radiculopathy.
- More than one stroke.
- Allergy or contraindication to the anesthesia, Versed, (or comparable substitute).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test an innovative, advanced FNS microstimulator technology developed by the Alfred Mann Foundation (Santa Clarita, CA) called, the Radio Frequency Microstimulation (RFM) Gait System that promises to provide FNS training for restoration of functional gait components in a manner at least as efficacious as current investigational FNS systems. The design features of the RFM Gait System are intended to address the problems with the current FNS systems. The RFM implant devices are small enough to be inserted using only a 5 mm incision[3]. Because both the electrode (anode and cathode) are contained within the microstimulator, there are no lead wires traversing the skin, joints, or torso/limb junctures. Individual RFMs can be inserted at the motor points and nerves of each of the paretic muscles in the involved limb and coordinated using radio frequency technology.
Read the detailed description
The primary objective (Aim I) of this study is to evaluate whether the RFM Gait System can restore the capability to perform the components of gait required for safe, functional walking, for patients in the chronic phase after stroke (> 12 months). We will assess the treatment provided by the RFM system at the Cleveland VA compared to the FNS percutaneous Schreiner electrodes and custom-designed controller previously investigated by the investigators.
The similarities between the RFM-based and percutaneous FNS systems will be assessed using six gait components required for the execution of functional, safe gait, which are lower limb strength, coordination, an index of walking endurance, muscle tone, walking speed, and quality of life.
The secondary objective of this study is to test the technological performance and safety of the RFM Gait System. Measures of technology performance and safety include implantation time; anchoring capability at the motor point of the muscle; reliability of the RFMs during use; reliability of electrical performance of the system; comfort of the system (with stimulation off); comfort of the electrical stimulus.
- Conditions
- Hemiparesis
- Being tested
- Radio-frequency Microstiumulator
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio-frequency MicrostiumulatorDevice
Also called The specific device name is the Radio Frequency Microstiumlator (RFM) System.
All participants will receive leg implants and will be trained first in the clinical and subsequently perform stimulation-assisted exercises in the home - for an overall duration of 6 months post-implant. Subsequently, exercise programs will continue without stimulation. Patient condition will be assessed at 9, 12 and 24 months post-implant.
| Study group | Role | What they receive |
|---|---|---|
| Implanted | Experimental | All participants. Receives: Device: Radio-frequency Microstiumulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Month 24 of swing phase gait components and knee control during stance phase with 6 gait components.
The six gait components listed below:
- Ankle plantar-flexion at Heel Strike
- Ankle Dorsiflexion during Peak Swing
- Knee Flexion at Toe Off
- Knee Flexion Peak Swing
- Knee Extension at Heel Strike
- Knee Flexion at Mid Stance
Measured: 24 months
Secondary outcomes (1)
Change from baseline to Month 24, without stimulation, of four scales and two QOL questionnaires.
The four scales are:Six Minute Walk Test, Manual Muscle Test, Fugl-Meyer Coordination Scale, and the Ashworth Scale.
The two QOL questionnaires are: Craig Handicap Assessment \& Reporting Technique (CHART) and Stroke Impact Scale (SIS):
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemiparesisStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred E. Mann Foundation for Scientific Research
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor
- Investigators
- Janis J Daly, PhD, MSPT, Principal investigator, Cleveland VA Medical CenterRobert Ruff, MD, PhD, Principal investigator, Cleveland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640041
- Sponsor's protocol ID
- AMF-CP-0004
- Other IDs
- GO70151
- Status last verified
- Jul 2012
- First submitted
- 22 Jun 2011
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Daly JJ, Roenigk K, Holcomb J, Rogers JM, Butler K, Gansen J, McCabe J, Fredrickson E, Marsolais EB, Ruff RL. A randomized controlled trial of functional neuromuscular stimulation in chronic stroke subjects. Stroke. 2006 Jan;37(1):172-8. doi: 10.1161/01.STR.0000195129.95220.77. Epub 2005 Dec 1.
PubMed 16322492Daly JJ, Ruff RL. Feasibility of combining multi-channel functional neuromuscular stimulation with weight-supported treadmill training. J Neurol Sci. 2004 Oct 15;225(1-2):105-15. doi: 10.1016/j.jns.2004.07.006.
PubMed 15465093Daly JJ, Kollar K, Debogorski AA, Strasshofer B, Marsolais EB, Scheiner A, Snyder S, Ruff RL. Performance of an intramuscular electrode during functional neuromuscular stimulation for gait training post stroke. J Rehabil Res Dev. 2001 Sep-Oct;38(5):513-26.
PubMed 11732829
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators
- ClinicalTrials.gov ID
- NCT01640041
- Acronym / sponsor ID
- AMF-CP-0004
- Conditions
- Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The Alfred E. Mann Foundation for Scientific ResearchUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Jul 2012 (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.
The purpose of this study is to test an innovative, advanced FNS microstimulator technology developed by the Alfred Mann Foundation (Santa Clarita, CA) called, the Radio Frequency Microstimulation (RFM) Gait System that promises to provide FNS training for restoration of functional gait components in a manner at least as efficacious as current investigational FNS systems. The design features of the RFM Gait System are intended to address the problems with the current FNS systems. The RFM implant devices are small enough to be inserted using only a 5 mm incision[3]. Because both the electrode (anode and cathode) are contained within the microstimulator, there are no lead wires traversing the skin, joints, or torso/limb junctures. Individual RFMs can be inserted at the motor points and nerves of each of the paretic muscles in the involved limb and coordinated using radio frequency technology.
Detailed description
The primary objective (Aim I) of this study is to evaluate whether the RFM Gait System can restore the capability to perform the components of gait required for safe, functional walking, for patients in the chronic phase after stroke (> 12 months). We will assess the treatment provided by the RFM system at the Cleveland VA compared to the FNS percutaneous Schreiner electrodes and custom-designed controller previously investigated by the investigators.
The similarities between the RFM-based and percutaneous FNS systems will be assessed using six gait components required for the execution of functional, safe gait, which are lower limb strength, coordination, an index of walking endurance, muscle tone, walking speed, and quality of life.
The secondary objective of this study is to test the technological performance and safety of the RFM Gait System. Measures of technology performance and safety include implantation time; anchoring capability at the motor point of the muscle; reliability of the RFMs during use; reliability of electrical performance of the system; comfort of the system (with stimulation off); comfort of the electrical stimulus.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted | Experimental | Device: Radio-frequency MicrostiumulatorAll participants. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Cognition intact to give valid informed consent to participate.
- Sufficient endurance to participate in rehabilitation sessions.
- Ability to follow 2 stage commands, in English.
- Medically stable.
- Age > 21 years.
Key exclusion criteria (5 listed)
- Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.
- Active psychiatric diagnosis or psychological condition, or active drug/alcohol abuse.
- Lower motor neuron damage or radiculopathy.
- More than one stroke.
- Allergy or contraindication to the anesthesia, Versed, (or comparable substitute).
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 |
|---|---|---|
| Radio-frequency MicrostiumulatorAlso: The specific device name is the Radio Frequency Microstiumlator (RFM) System.All participants will receive leg implants and will be trained first in the clinical and subsequently perform stimulation-assisted exercises in the home - for an overall duration of 6 months post-implant. Subsequently, exercise programs will continue without stimulation. Patient condition will be assessed at 9, 12 and 24 months post-implant. | Device | Implanted |
Primary outcome
Change from baseline to Month 24 of swing phase gait components and knee control during stance phase with 6 gait components.
Time frame: 24 months
The six gait components listed below: 1. Ankle plantar-flexion at Heel Strike 2. Ankle Dorsiflexion during Peak Swing 3. Knee Flexion at Toe Off 4. Knee Flexion Peak Swing 5. Knee Extension at Heel Strike 6. Knee Flexion at Mid Stance
1 secondary outcome
Change from baseline to Month 24, without stimulation, of four scales and two QOL questionnaires.
Time frame: 24 months
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 25 Jan 2017.
- Background: PubMed 16322492Daly JJ, Roenigk K, Holcomb J, Rogers JM, Butler K, Gansen J, McCabe J, Fredrickson E, Marsolais EB, Ruff RL. A randomized controlled trial of functional neuromuscular stimulation in chronic stroke subjects. Stroke. 2006 Jan;37(1):172-8. doi: 10.1161/01.STR.0000195129.95220.77. Epub 2005 Dec 1.
- Background: PubMed 15465093Daly JJ, Ruff RL. Feasibility of combining multi-channel functional neuromuscular stimulation with weight-supported treadmill training. J Neurol Sci. 2004 Oct 15;225(1-2):105-15. doi: 10.1016/j.jns.2004.07.006.
- Background: PubMed 11732829Daly JJ, Kollar K, Debogorski AA, Strasshofer B, Marsolais EB, Scheiner A, Snyder S, Ruff RL. Performance of an intramuscular electrode during functional neuromuscular stimulation for gait training post stroke. J Rehabil Res Dev. 2001 Sep-Oct;38(5):513-26.
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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.
Janis J Daly, PhD, MSPT principal investigator
Cleveland VA Medical Center
Robert Ruff, MD, PhD principal investigator
Cleveland VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radio-frequency Microstiumulator in people with Hemiparesis, run by The Alfred E. Mann Foundation for Scientific Research at 1 site in United States.
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 15 inclusion and 5 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 25 Jan 2017. 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 United States. 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 from baseline to Month 24 of swing phase gait components and knee control during stance phase with 6 gait components. (time frame: 24 months). 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 NCT01640041, which also lists 3 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 25 Jan 2017; AzTrials last refreshed its copy on 28 Oct 2026.