Neonatal Brachial Plexus PalsyNCT01999465
NMES Efficacy on Patients With NBPP
A study testing Standard NMES device in people with Neonatal Brachial Plexus Palsy, run by University of Michigan at 1 site in United States.
Trial summary
Neonatal Brachial Plexus Palsy (NBPP), characterized by weakness and sensory loss in the affected arm, results from damage in the prenatal period to the nerves extending from the spine to the arm. Read more about this study
- Who is it for?
- Ages 3 to 9 months
- Conditions the study is for
- Neonatal Brachial Plexus Palsy
- What is being tested?
- Standard NMES device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 3-9 months at time of enrollment
- NBPP patients who receive care from University Of Michigan Brachial Plexus Palsy clinic
- All gender/race/financial backgrounds
- active range of motion (AROM) elbow flexion <150°
- All Narakas grades
- British Medical Research Council (MRC) grade 2- or 4 for biceps brachii
Who cannot join
- Brachial Plexus patients require needing surgical repair
- Patients with any existing secondary medical conditions
- Patients with elbow contracture greater than 5°
- British Medical Research Council (MRC) grade 5 for biceps brachii
- active range of motion (AROM) elbow flexion =150°
- Non-English speaking families
- Children already using NMES unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Electrical Stimulation (NMES) Efficacy on Patients With Neonatal Brachial Plexus Palsy (NBPP)
Neonatal Brachial Plexus Palsy (NBPP), characterized by weakness and sensory loss in the affected arm, results from damage in the prenatal period to the nerves extending from the spine to the arm. Proper stretching and exercise of the joints and affected arm from the time of diagnosis can greatly assist in the development of healthy movement of the limb. Additionally, neuromuscular electrical stimulation has been shown to be an effective treatment in other neural disorders and therefore its effectiveness in NBPP is worth studying.
In the case of NBPP patients, the loss in normal arm function can be observed very early. Young patients will often neglect using the affected arm or modify motions to avoid the use of the biceps muscle, specifically in hand to mouth actions such as gripping a bottle or placing toys or other objects in the mouth. A goal of this study is to test the effectiveness of NMES on improving the biceps muscle Medical Research Council (MRC) strength and active range of motion (AROM).
Read more
The subjects of this study are newborns between the ages of 3-9 months who are already a part of the University of Michigan Brachial Plexus program. Parents of the children will be trained to perform the neuromuscular electrical stimulation therapy at home using the EMPI Continuum unit for 30 minutes each day and monthly follow up appointments will be performed be the research occupational therapists throughout three month study period.
Parents of the participants will complete a questionnaire before and during the study period to help analyze for confounders and gather data regarding parent compliance and NMES effectiveness. To detect the effectiveness of NMES, two cohort groups using standard units and sham units will be recruited and compare with data analysis.
The investigators predict that the NMES will effectively improve the ability of the neonate to increase use of the affected arm, specifically in muscle strength biceps MRC score and AROM.
Read the detailed description
The purpose of this study is to investigate whether the use of Neuromuscular Electrical Stimulation (NMES), via the Empi® Continuum unit, will improve the ability with which children with Neonatal Brachial Plexus Palsy (NBPP) are able to use their biceps muscle in activities of daily living. We will examine the British Medical Research Council (MRC) muscle strength and participants' ability to perform active range of motion (AROM) movements. Patients will be divided into two groups with one group receiving NMES and the other receiving sham NMES. We plan to analyze the effects of this one treatment intervention of NMES to determine if the device improves the function of the biceps muscle strength and motion.
- Conditions
- Neonatal Brachial Plexus Palsy
- Being tested
- Standard NMES device, Sham NMES device
- Keywords
- Brachial plexus injury, Brachial plexus palsy, Neonate
- Medical subject headings
- Neonatal Brachial Plexus Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard NMES deviceDevice
Also called Neuromuscular electrical stimulation (NMES)
Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.
- Rate(35 Hz)
- Width (300 us)
- Ch1 Ramp+ (2 seconds)
- On Time 1 (10 seconds)
- Ch1 Ramp - (2 seconds)
Sham NMES deviceDevice
Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.
- Rate(35 Hz)
- Width (48 us)
- Ch1 Ramp+ (0 seconds)
- On Time 1 (0 seconds)
- Ch1 Ramp - (0 seconds)
| Study group | Role | What they receive |
|---|---|---|
| Standard NMES cohort | Active comparator | Patients who will apply standard NMES device. Receives: Device: Standard NMES device |
| Sham NMES cohort | Sham comparator | Patients who will apply sham NMES device. Receives: Device: Sham NMES device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Upper Extremity Muscle Strength
One of the two-blinded occupational therapists will conduct the evaluation at enrollment and 3-month follow-up clinic visit. In this study, we will evaluate the biceps strength using the British Medical Research Council (MRC) grading system. The British Medical Research Council (MRC) grading system for muscle strength is based on a scale from 0 (minimum score, not testable), 1, 2, 3, 4, to 5 (maximum score, normal strength); higher score means better outcome. British Medical Research Council (MRC) grade 2 or higher is functional in terms of muscle power. In current study, we will examine the change of biceps British Medical Research Council (MRC) grade from baseline to 3-month.
Measured: Baseline to 3-month.
Change From Baseline in Upper Extremity Range of Motion
One of the two-blinded occupational therapists will assess the active range of motion (AROM) of elbow flexion using goniometer at enrollment and 3-month follow-up clinic visit. The minimum degree is 0 and the maximum degree is 150; the higher degree means better outcome. We will then examine the change of elbow flexion active range of motion (AROM) from baseline to 3-month.
Measured: Baseline to 3-month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startNov 2013
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neonatal Brachial Plexus PalsyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 N/A
- 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 Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Spring Arbor University
- Responsible party
- Principal investigator, Lynda Yang, University of Michigan
- Investigators
- Lynda Yang, MD, PhD, Principal investigator, Neurosurgery Department, University of Michigan Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999465
- Sponsor's protocol ID
- MedSAU-NMES
- Status last verified
- Dec 2018
- First submitted
- 29 Oct 2013
- Last updated
- 14 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation (NMES) Efficacy on Patients With Neonatal Brachial Plexus Palsy (NBPP)
- ClinicalTrials.gov ID
- NCT01999465
- Acronym / sponsor ID
- MedSAU-NMES
- Conditions
- Neonatal Brachial Plexus Palsy
- Keywords
- Brachial plexus injury, Brachial plexus palsy, Neonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Spring Arbor University
- Study start
- Nov 2013 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Posted 14 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neonatal Brachial Plexus Palsy (NBPP), characterized by weakness and sensory loss in the affected arm, results from damage in the prenatal period to the nerves extending from the spine to the arm. Proper stretching and exercise of the joints and affected arm from the time of diagnosis can greatly assist in the development of healthy movement of the limb. Additionally, neuromuscular electrical stimulation has been shown to be an effective treatment in other neural disorders and therefore its effectiveness in NBPP is worth studying.
In the case of NBPP patients, the loss in normal arm function can be observed very early. Young patients will often neglect using the affected arm or modify motions to avoid the use of the biceps muscle, specifically in hand to mouth actions such as gripping a bottle or placing toys or other objects in the mouth. A goal of this study is to test the effectiveness of NMES on improving the biceps muscle Medical Research Council (MRC) strength and active range of motion (AROM).
The subjects of this study are newborns between the ages of 3-9 months who are already a part of the University of Michigan Brachial Plexus program. Parents of the children will be trained to perform the neuromuscular electrical stimulation therapy at home using the EMPI Continuum unit for 30 minutes each day and monthly follow up appointments will be performed be the research occupational therapists throughout three month study period.
Parents of the participants will complete a questionnaire before and during the study period to help analyze for confounders and gather data regarding parent compliance and NMES effectiveness. To detect the effectiveness of NMES, two cohort groups using standard units and sham units will be recruited and compare with data analysis.
The investigators predict that the NMES will effectively improve the ability of the neonate to increase use of the affected arm, specifically in muscle strength biceps MRC score and AROM.
Detailed description
The purpose of this study is to investigate whether the use of Neuromuscular Electrical Stimulation (NMES), via the Empi® Continuum unit, will improve the ability with which children with Neonatal Brachial Plexus Palsy (NBPP) are able to use their biceps muscle in activities of daily living. We will examine the British Medical Research Council (MRC) muscle strength and participants' ability to perform active range of motion (AROM) movements. Patients will be divided into two groups with one group receiving NMES and the other receiving sham NMES. We plan to analyze the effects of this one treatment intervention of NMES to determine if the device improves the function of the biceps muscle strength and motion.
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 |
|---|---|---|
| Standard NMES cohort | Active comparator | Device: Standard NMES devicePatients who will apply standard NMES device. |
| Sham NMES cohort | Sham comparator | Device: Sham NMES devicePatients who will apply sham NMES device. |
Who may qualify
- Ages
- 3 to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children ages 3-9 months at time of enrollment
- NBPP patients who receive care from University Of Michigan Brachial Plexus Palsy clinic
- All gender/race/financial backgrounds
- active range of motion (AROM) elbow flexion <150°
- All Narakas grades
Key exclusion criteria (7 listed)
- Brachial Plexus patients require needing surgical repair
- Patients with any existing secondary medical conditions
- Patients with elbow contracture greater than 5°
- British Medical Research Council (MRC) grade 5 for biceps brachii
- active range of motion (AROM) elbow flexion =150°
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 |
|---|---|---|
| Standard NMES deviceAlso: Neuromuscular electrical stimulation (NMES)Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months. * Rate(35 Hz) * Width (300 us) * Ch1 Ramp+ (2 seconds) * On Time 1 (10 seconds) * Ch1 Ramp - (2 seconds) | Device | Standard NMES cohort |
| Sham NMES deviceBlinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months. * Rate(35 Hz) * Width (48 us) * Ch1 Ramp+ (0 seconds) * On Time 1 (0 seconds) * Ch1 Ramp - (0 seconds) | Device | Sham NMES cohort |
Primary outcome
Change From Baseline in Upper Extremity Muscle Strength
Time frame: Baseline to 3-month.
One of the two-blinded occupational therapists will conduct the evaluation at enrollment and 3-month follow-up clinic visit. In this study, we will evaluate the biceps strength using the British Medical Research Council (MRC) grading system. The British Medical Research Council (MRC) grading system for muscle strength is based on a scale from 0 (minimum score, not testable), 1, 2, 3, 4, to 5 (maximum score, normal strength); higher score means better outcome. British Medical Research Council (MRC) grade 2 or higher is functional in terms of muscle power. In current study, we will examine the change of biceps British Medical Research Council (MRC) grade from baseline to 3-month.
Change From Baseline in Upper Extremity Range of Motion
Time frame: Baseline to 3-month.
One of the two-blinded occupational therapists will assess the active range of motion (AROM) of elbow flexion using goniometer at enrollment and 3-month follow-up clinic visit. The minimum degree is 0 and the maximum degree is 150; the higher degree means better outcome. We will then examine the change of elbow flexion active range of motion (AROM) from baseline to 3-month.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Neonatal Brachial Plexus Palsy
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Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
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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.
Lynda Yang, MD, PhD principal investigator
Neurosurgery Department, University of Michigan Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard NMES device in people with Neonatal Brachial Plexus Palsy, run by University of Michigan 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 6 inclusion and 7 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 14 Dec 2018. 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. 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?
Yes. Results are posted in the registry (first posted 14 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Upper Extremity Muscle Strength (time frame: Baseline to 3-month.). The study lists 2 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 14 Dec 2018.