Infant Development, Hemiplegia, Constraint Induced Movement Therapy
Conditions
Keywords
transcutaneous auricular vagus nerve stimulation, constraint induced movement therapy, infant hemiplegia
Brief summary
Newborns who are born premature or suffer brain injury at birth are at risk for motor problems that may cause weakness in reaching and grasping on one side of the body. In older children, therapists may use a hand mitt and restraint for the stronger arm, to encourage use of the weaker side, called constraint-induced movement therapy (CIMT). Even with the high intensity therapy of CIMT, it typically takes between 40-120 hours total treatment time for most children to improve their motor skills. A non-invasive form of nerve stimulation, transcutaneous auricular vagus nerve stimulation (taVNS), stimulates a nerve by the ear that enhances learning motor skills. The purpose of this study is to evaluate the safety and effectiveness of taVNS to improve motor skills when paired with CIMT in infants with one-sided weakness at 6-18months of age.
Detailed description
Recent pioneering studies have used neuromodulation combined with intensive motor therapies in adults after stroke. Few studies have investigated combining neuromodulation and evidence-based pediatric intensive therapies such as CIMT, and then only in older children with CP to enhance neuroplasticity and improve functional outcomes. The investigators are the first to use non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) paired with a motor task of bottle-feeding in infants with feeding failure. taVNS paired with motor feeding activity was safe and over 50% infants attained full oral feeds who were slated to receive a gastrostomy tube (G-tube). With the unique collaboration of experts in brain stimulation, pediatric translational clinical science and pediatric occupational therapy in this pilot project, the investigators propose to expand the paradigm of pairing neuromodulation with motor training in at-risk infants by exploring the safety, feasibility, and effectiveness of delivering taVNS concurrently with CIMT. The hypothesis is that combining taVNS with intensive CIMT may boost neuroplasticity, allowing for delivery of infant therapy at a minimally effective dosage while improving infant outcomes. The investigators aim to determine the feasibility and safety of taVNS in at-risk infants 6-18mo undergoing CIMT therapy in open label pilot trial and assess both infant tolerability and the therapist's ability to deliver high-quality CIMT along with taVNS.
Interventions
DEVICEtranscutaneous auricular vagus nerve stimulation
Applying a pulsed microcurrent to the auricular branch of the vagus nerve, timed with motor activity of the weaker arm/hand
Applying a custom-made splint constraint to the stronger hand/arm to encourage use of the weaker hand/arm in intensive therapy sessions
Sponsors
National Center of Neuromodulation for Rehabilitation
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
CIMT plus taVNS
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Months
Healthy volunteers
No
Inclusion criteria
Must have all of the following: * 6-18 month-old infants with hemiplegia/motor asymmetry * Must be able to participate in high intensity CIMT * Gross Motor Function Classification System (GMFCS) level I-IV
Exclusion criteria
Must have none of the following: * GMFCS level V * severe motor impairment/quadriplegic involvement * uncorrected blindness or deafness * cardiomyopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CIMT Fidelity | at 1 month | Feasibility of delivering high fidelity CIMT therapy sessions while the therapist is also triggering taVNS using the Fidelity of Implementation Measure (FIRM) with scoring range (0-4), higher scores indicate greater consistency of therapy with established CIMT procedure |
| Quality of Upper Extremity Skills Test (QUEST), GRASP | 1 month | change in test of hand function and quality of movement between the right and left sides of the body, scoring range 0-100, higher scores indicate better hand function; from baseline to end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function Measure-88 (GMFM-88) | 1 month | The Gross Motor Function Measure-88 (GMFM-88) assessment tool includes 88 items, each receiving a score from 0 to 3 (0 = does not initiate; 1 = initiates; 2 = partially completes; 3 = completes). Items span the spectrum of gross motor activities in five dimensions: A: Lying and Rolling (17 items), B: Sitting (20 items), C: Crawling and Kneeling (14 items), D: Standing (13 items), E: Walking, Running, Jumping (24 items). Every dimension score is expressed with a percentage. All dimension scores are then averaged to a total GMFM-88 percentage score, which is an estimate of the participant's gross motor function (0 = low motor function; 100 = high motor function). |
Countries
United States
Participant flow
Recruitment details
We recruited participants from referrals from neonatal high risk development clinic, and referral from other rehab professionals seeing patients in their clinics from June 1, 2021 to July 30, 2024.
Pre-assignment details
open label study without a washout period. all participants were receiving physical and occupational therapy for hemiplegia
Participants by arm
| Arm | Count |
|---|---|
| Open Label taVNS Paired With 40 Hours CIMT infants with hemiplegia receive taVNs paired with constraint induced movement therapy for a total of 40h, 2h a day 5 days a week for 4 weeks | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Open Label taVNS Paired With 40 Hours CIMT |
|---|---|
| Age, Continuous | 16.7 months of age |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
CIMT Fidelity
Feasibility of delivering high fidelity CIMT therapy sessions while the therapist is also triggering taVNS using the Fidelity of Implementation Measure (FIRM) with scoring range (0-4), higher scores indicate greater consistency of therapy with established CIMT procedure
Time frame: at 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Open Label taVNS Paired With 40 Hours CIMT | CIMT Fidelity | 3.76 score on a scale |
Primary
Quality of Upper Extremity Skills Test (QUEST), GRASP
change in test of hand function and quality of movement between the right and left sides of the body, scoring range 0-100, higher scores indicate better hand function; from baseline to end of treatment
Time frame: 1 month
Population: entire group (n=6) received 40h of CIMT with taVNS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label taVNS Paired With 40 Hours CIMT | Quality of Upper Extremity Skills Test (QUEST), GRASP | 209 percentage of change from baseline | Standard Deviation 161 |
Secondary
Gross Motor Function Measure-88 (GMFM-88)
The Gross Motor Function Measure-88 (GMFM-88) assessment tool includes 88 items, each receiving a score from 0 to 3 (0 = does not initiate; 1 = initiates; 2 = partially completes; 3 = completes). Items span the spectrum of gross motor activities in five dimensions: A: Lying and Rolling (17 items), B: Sitting (20 items), C: Crawling and Kneeling (14 items), D: Standing (13 items), E: Walking, Running, Jumping (24 items). Every dimension score is expressed with a percentage. All dimension scores are then averaged to a total GMFM-88 percentage score, which is an estimate of the participant's gross motor function (0 = low motor function; 100 = high motor function).
Time frame: 1 month
Population: entire group that received 40h of CIMT paired with taVNS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label taVNS Paired With 40 Hours CIMT | Gross Motor Function Measure-88 (GMFM-88) | 32 units on a scale | Standard Deviation 28 |