NMES Efficacy on Patients With NBPP

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. 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.

Conditions

• Neonatal Brachial Plexus Palsy

Interventions

DEVICE

Standard NMES device

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

Sham NMES device

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)

Sponsors & Collaborators

• Spring Arbor University

  collaborator UNKNOWN

• University of Michigan

  lead OTHER

Principal Investigators

• Lynda Yang, MD, PhD · Neurosurgery Department, University of Michigan Health System

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

9 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2018-01-31

Completion

2018-01-31

Countries

• United States

Study Locations