Spinal Cord Injury at C5-C7 Level With Incomplete LesionNCT00781833
Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury
A study testing Radio Frequency Microstimulator in people with Spinal Cord Injury at C5-C7 Level With Incomplete Lesion, run by The Alfred E. Mann Foundation for Scientific Research at 1 site in United States.
Trial summary
The primary aims of this study are to determine the safety of the RFM System (Alfred Mann Foundation, Santa Clarita, CA) in a patient with incomplete SCI and the effect of the RFM system on lower limb strength and spasticity. The secondary aim is to analyze any improvement in the participant's mobility. Read more about this study
- Who is it for?
- Ages 55 to 55 years, men only
- Conditions the study is for
- Spinal Cord Injury at C5-C7 Level With Incomplete Lesion
- What is being tested?
- Radio Frequency Microstimulator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 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 55 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- an incomplete C6 ASIA C (Central Cord) spinal cord injury
- lower motor function impaired and suffers from significant spasticity (Ashworth scale 4)
- able to ambulate approximately 10-20 feet with a rolling walker and minimal assistance
- has sufficient endurance to complete at least two 20-minute therapy sessions per day
- cognitive abilities are intact
Who cannot join
- psychiatric diagnosis
- medical contraindications
- history of bleeding disorders
- allergy to anesthesia
- acute or progressive disease
- active implantable device
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
Official title: Case Study Testing the Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury
The primary aims of this study are to determine the safety of the RFM System (Alfred Mann Foundation, Santa Clarita, CA) in a patient with incomplete SCI and the effect of the RFM system on lower limb strength and spasticity. The secondary aim is to analyze any improvement in the participant's mobility.
Read the detailed description
Restoring mobility after spinal cord injury (SCI) is one of the most important goals of rehabilitation. Even for patients with partial lower limb motor function after SCI, many have limited mobility because of significant spasticity. Therapeutic electrical neuromuscular stimulation (TNS) has been used to improve muscle tone and strength and to enable walking and standing in patients with SCI. We propose to use the Radio Frequency Microstimulator (RFM) System, a new and novel implantable TNS system developed by the Alfred E. Mann Foundation, to improve muscle strength and reduce spasticity in a patient with incomplete SCI. The RFM System has several advantages over current TNS systems. The RFM implant devices are small enough (diameter 2.4 mm, length 16.7 mm) to be inserted using an incision approximately 5 mm long and have no lead wires passing through the skin since the microstimulator contains both the anode and cathode. Implanted RFM devices can be placed near multiple motor points and/or nerves and are controlled individually using radio frequency technology. Up to six (6) RFM devices will be inserted, two to three in each lower limb to provide stimulation to a patient's bilateral knee extensors (femoral nerve stimulation) and ankle dorsiflexors (peroneal nerve stimulation) to assess the effects on muscle strength, limb spasticity and patient mobility.
- Being tested
- Radio Frequency Microstimulator
- Keywords
- Therapeutic Electric Stimulation, Functional Electric Stimulation, Implantable Stimulator, Muscle Strength, Muscle Spasticity
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio Frequency MicrostimulatorDevice
Implantable peripheral muscle microstimulator, delivering controlled pulsatile stimulation to femoral nerves for knee extension and peroneal nerves for dorsiflexion.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Intramuscular Electrical Stimulation Receives: Device: Radio Frequency Microstimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: Throughout
Lower Limb Strength
Measured: 6, 12, 24 weeks, 12, 24 months
Lower Limb Spasticity
Measured: 6, 12, 24 weeks, 12, 24 months
Secondary outcomes (1)
Mobility
Measured: 6, 12, 24 weeks, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Participation of single subject enrolled was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury at C5-C7 Level With Incomplete LesionStudies 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
- 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
- Walter Reed Army Medical Center
- Responsible party
- Sponsor
- Investigators
- KEVIN F FITZPATRICK, M.D., Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781833
- Sponsor's protocol ID
- AMF CP-005
- Status last verified
- Jan 2012
- First submitted
- 27 Oct 2008
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Study Testing the Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00781833
- Acronym / sponsor ID
- AMF CP-005
- Keywords
- Therapeutic Electric Stimulation, Functional Electric Stimulation, Implantable Stimulator, Muscle Strength, Muscle Spasticity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participation of single subject enrolled was terminated.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The Alfred E. Mann Foundation for Scientific ResearchUniversity, hospital or other
- Collaborators
- Walter Reed Army Medical Center
- Study start
- Oct 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Oct 2008 (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 primary aims of this study are to determine the safety of the RFM System (Alfred Mann Foundation, Santa Clarita, CA) in a patient with incomplete SCI and the effect of the RFM system on lower limb strength and spasticity. The secondary aim is to analyze any improvement in the participant's mobility.
Detailed description
Restoring mobility after spinal cord injury (SCI) is one of the most important goals of rehabilitation. Even for patients with partial lower limb motor function after SCI, many have limited mobility because of significant spasticity. Therapeutic electrical neuromuscular stimulation (TNS) has been used to improve muscle tone and strength and to enable walking and standing in patients with SCI. We propose to use the Radio Frequency Microstimulator (RFM) System, a new and novel implantable TNS system developed by the Alfred E. Mann Foundation, to improve muscle strength and reduce spasticity in a patient with incomplete SCI. The RFM System has several advantages over current TNS systems. The RFM implant devices are small enough (diameter 2.4 mm, length 16.7 mm) to be inserted using an incision approximately 5 mm long and have no lead wires passing through the skin since the microstimulator contains both the anode and cathode. Implanted RFM devices can be placed near multiple motor points and/or nerves and are controlled individually using radio frequency technology. Up to six (6) RFM devices will be inserted, two to three in each lower limb to provide stimulation to a patient's bilateral knee extensors (femoral nerve stimulation) and ankle dorsiflexors (peroneal nerve stimulation) to assess the effects on muscle strength, limb spasticity and patient mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Radio Frequency MicrostimulatorIntramuscular Electrical Stimulation |
Who may qualify
- Ages
- 55 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- an incomplete C6 ASIA C (Central Cord) spinal cord injury
- lower motor function impaired and suffers from significant spasticity (Ashworth scale 4)
- able to ambulate approximately 10-20 feet with a rolling walker and minimal assistance
- has sufficient endurance to complete at least two 20-minute therapy sessions per day
- cognitive abilities are intact
Key exclusion criteria (6 listed)
- psychiatric diagnosis
- medical contraindications
- history of bleeding disorders
- allergy to anesthesia
- acute or progressive 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 |
|---|---|---|
| Radio Frequency MicrostimulatorImplantable peripheral muscle microstimulator, delivering controlled pulsatile stimulation to femoral nerves for knee extension and peroneal nerves for dorsiflexion. | Device | Treatment |
Primary outcome
Adverse Events
Time frame: Throughout
Lower Limb Strength
Time frame: 6, 12, 24 weeks, 12, 24 months
Lower Limb Spasticity
Time frame: 6, 12, 24 weeks, 12, 24 months
1 secondary outcome
Mobility
Time frame: 6, 12, 24 weeks, 12, 24 months
Results and safety
The study was stopped early (reason given: Participation of single subject enrolled was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
Related trials for Spinal Cord Injury at C5-C7 Level With Incomplete Lesion
Recruiting
Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury
Spinal Cord Injuries, Spinal Cord Injury at C5-C7 Level
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.
KEVIN F FITZPATRICK, M.D. principal investigator
Walter Reed Army 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 Microstimulator in people with Spinal Cord Injury at C5-C7 Level With Incomplete Lesion, 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 23 Jan 2012. 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 was stopped early (reason given: Participation of single subject enrolled was terminated.). Results are not available in the source record.
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?
Adverse Events (time frame: Throughout). The study lists 3 primary outcomes in all. 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 23 Jan 2012.