Cerebral PalsyEarly Phase 1NCT05857527

Extending taVNS Paired With Infant CIMT Into a Home-Based Setting

A Early Phase 1 study testing Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in lab and Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in home in people with Cerebral Palsy, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 to 18 months
Conditions the study is for: Cerebral Palsy
What is being tested?: Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in lab and Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in home
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 17 Apr 2023to 30 Mar 2024
Phase: Early Phase 1
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 6 to 18 months
All sexes
No healthy volunteers
Child

Who may be able to join

Five 6-18-month-old infants
Hemiplegia/motor asymmetry qualifying for Constraint Induced Movement Therapy
Gross Motor Function Classification System (GMFCS) level I-IV
Ability to maintain a sitting position for 5 minutes with moderate assistance

Who cannot join

GMFCS level V
Severe motor impairment/ quadriplegic involvement
Uncorrected blindness or deafness
Cardiomyopathy

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Extending taVNS Paired With Infant CIMT Into a Home-Based Setting: Technology Development Requisite for a Randomized Trial

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. taVNS stimulation will be triggered by EMG sensors which detect muscle activity. 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 6-18 months of age.

Read the detailed description

Preterm birth and complications in term births can result in increased risk for intraventricular hemorrhage, global hypoxia-ischemia (HIE), arterial stoke, and neuroinflammation with white matter injury in newborns. Centeral Nervous System (CNS) injuries then may manifest as early developmental delays and motor weakness in the first 12 months, that presage hemiplegic cerebral palsy (CP).

Early targeted therapy interventions for high-risk infants aim to improve neurological outcomes by taking advantage of critical windows for neuroplasticity. Intensive interventions, such as constraint-induced movement therapy (CIMT), are designed to ameliorate early motor predecessors of CP in at-risk infants. This intervention must be provided at a minimally effective dosage of 40 hours, and 60-120 hours for optimal outcomes, and are typically provided in a condensed time period, over 4 to 6 weeks with intensive task-practice for 3-6 hours a day. Delivering CIMT within the context a typical family day is a challenge. Interventional strategies that reduce the time requirement while offering the same or better outcomes would benefit families and facilitate treatment delivery.

Few studies have used neuromodulation combined with intensive motor therapies, such as CIMT, to enhance neuroplasticity and improve functional outcomes in children. Transcranial direct current stimulation has been used safely in older children with CP during bimanual learning therapy. Our group is 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 determined to need a gastrostomy tube (G-tube) attained full oral feeds (mean time to full oral feeds 15 days with once daily, and 7.8 days with twice daily treatment). This study will use EMG sensing of muscle activity to trigger the taVNS system. Use of EMG sensors is hypothesized to improve pairing of stimulation with motor activity while also decreasing the treatment burden for the therapist.

Conditions: Cerebral Palsy
Being tested: Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in lab, Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in home
Medical subject headings: Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in labCombination product
Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 1 will occur in the lab, and ongoing notifications will be made to the EMG system to test feasibility of automatic stimulation
Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in homeCombination product
Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 2 will occur in the home and will assess the quality of the CIMT therapy provided with the automated EMG system.

Study groups in NCT05857527
Study group	Role	What they receive
EMG triggering feasibility	Experimental	We will trial use of a new taVNS unit that uses automated EMG sensors to trigger stimulation and an optional Bluetooth manual trigger. This experimental device will be used to during CIMT rehabilitation treatment to pair stimulation with active movement. Receives: Combination Product: Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in lab
taVNS and EMG feasibility at home	Experimental	For the 2nd phase of the study we will trial using the EMG triggered system to deliver taVNS and CIMT in the home setting. Receives: Combination Product: Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in home

What is being measured

The primary outcome is the main question the study is designed to answer.

Device Feasibility
Feasibility is measured as percent of total treatment time Electromyography (EMG) can successfully trigger stimulation during a Constraint induced movement therapy (CIMT) rehabilitation session.
Measured: end of 4 week treatment intervention (40 hours of CIMT)

Secondary outcomes (2)

Fidelity of Implementation Measure (FIRM)
Fidelity Rating of Quality of Constraint Induced Movement Therapy Delivery while using the experimental EMG triggered Soterix taVNS stimulator.
Fidelity of Implementation Measure (FIRM) which describes how consistently therapists exhibit behaviors consistent with CIMT principles and operant conditioning techniques and are rated on a scale of 1-4. A 4 being consistently demonstrating with less than 1 exception, and 1 being rarely or not at all. A score of 3 indicates acceptable to high fidelity.
Measured: end of 4 week treatment intervention (40 hours of CIMT)
Quality of Upper Extremity Skills Test (QUEST)
Quality of Upper Extremity Skills Test The QUEST is a criterion-referenced measure designed to evaluate the quality of upper extremity function in young children with spasticity. We calculated scores from 2 domains:1) Dissociated movement and2) Grasp Item scores are summed; formulas are used to calculate percentages for each domain. Domain percentages are summed and divided by number of domains (2 for our study) to obtain total score. Minimum score = 0; Maximum score = 100 The total QUEST score was calculated by summing scores for each sub-domain tested divided by the total number of sub-domains tested. The total scores on the QUEST range from 0 to 100. Higher scores represent better quality of movement.
Measured: Change in functional motor outcome completed pre and post 40 hours of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 202330 Mar 2024

First posted12 May 2023
Study start17 Apr 2023
Primary completion30 Mar 2024
Study completion30 Mar 2024

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 Cerebral PalsyStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe 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: Early Phase 1
Primary purpose: Device feasibility
Allocation: Non-randomised
Intervention model: Sequential
Model description: For this study we are making modifications to the taVNS stimulation (Soterix unit) system. These modifications include using Electromyography (EMG) muscle sensors to trigger stimulation instead of a manual button. We are also transitioning the manual stimulation option to Bluetooth to improve ease of use in the clinic with infants. The taVNS stimulation will be paired with constraint induced movement therapy (CIMT) an established rehabilitation intervention. The Soterix taVNS unit is FDA registered and is a custom version of an FDA cleared device. The first 2 participants will complete phase 1 of the study. In this phase we will make adjustments to the EMG system and physical set up with the goal of having the EMG sensors trigger taVNS stimulation with 75% of total time for active arma and trunk movements during CIMT. In phase 2 we will use the EMG triggered taVNS setup to deliver CIMT in home.
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05857527
Sponsor's protocol ID: Pro00123579
Status last verified: Jul 2025
First submitted: 23 Feb 2023
Last updated: 4 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cerebral Palsy trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Extending taVNS Paired With Infant CIMT Into a Home-Based Setting: Technology Development Requisite for a Randomized Trial
ClinicalTrials.gov ID: NCT05857527
Acronym / sponsor ID: Pro00123579
Conditions: Cerebral Palsy
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 17 Apr 2023 (actual)
Primary completion: 30 Mar 2024 (actual)
Study completion: 30 Mar 2024 (actual)
First posted: 12 May 2023 (actual)
Results: Posted 4 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Device feasibility
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: For this study we are making modifications to the taVNS stimulation (Soterix unit) system. These modifications include using Electromyography (EMG) muscle sensors to trigger stimulation instead of a manual button. We are also transitioning the manual stimulation option to Bluetooth to improve ease of use in the clinic with infants. The taVNS stimulation will be paired with constraint induced movement therapy (CIMT) an established rehabilitation intervention. The Soterix taVNS unit is FDA registered and is a custom version of an FDA cleared device. The first 2 participants will complete phase 1 of the study. In this phase we will make adjustments to the EMG system and physical set up with the goal of having the EMG sensors trigger taVNS stimulation with 75% of total time for active arma and trunk movements during CIMT. In phase 2 we will use the EMG triggered taVNS setup to deliver CIMT in home.

Arm	Type	Receives
EMG triggering feasibility	Experimental	Combination Product: Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in labWe will trial use of a new taVNS unit that uses automated EMG sensors to trigger stimulation and an optional Bluetooth manual trigger. This experimental device will be used to during CIMT rehabilitation treatment to pair stimulation with active movement.
taVNS and EMG feasibility at home	Experimental	Combination Product: Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in homeFor the 2nd phase of the study we will trial using the EMG triggered system to deliver taVNS and CIMT in the home setting.

Who may qualify

Ages: 6 to 18 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Five 6-18-month-old infants
Hemiplegia/motor asymmetry qualifying for Constraint Induced Movement Therapy
Gross Motor Function Classification System (GMFCS) level I-IV
Ability to maintain a sitting position for 5 minutes with moderate assistance

Key exclusion criteria (4 listed)

GMFCS level V
Severe motor impairment/ quadriplegic involvement
Uncorrected blindness or deafness
Cardiomyopathy

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
Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in labParticipants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 1 will occur in the lab, and ongoing notifications will be made to the EMG system to test feasibility of automatic stimulation	Combination product	EMG triggering feasibility
Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in homeParticipants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 2 will occur in the home and will assess the quality of the CIMT therapy provided with the automated EMG system.	Combination product	taVNS and EMG feasibility at home

Primary outcome

Device Feasibility
Time frame: end of 4 week treatment intervention (40 hours of CIMT)
Feasibility is measured as percent of total treatment time Electromyography (EMG) can successfully trigger stimulation during a Constraint induced movement therapy (CIMT) rehabilitation session.

2 secondary outcomes

Fidelity of Implementation Measure (FIRM)
Time frame: end of 4 week treatment intervention (40 hours of CIMT)
Quality of Upper Extremity Skills Test (QUEST)
Time frame: Change in functional motor outcome completed pre and post 40 hours of treatment

Results and safety

Results posted to the registry on 4 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Custom EMG Triggered Soterix taVNS Stimulation With CIMT Therapy in Lab	2	2
Custom EMG Triggered Soterix taVNS Stimulation With CIMT Therapy in Home	2	1

Primary outcome: Device Feasibility

Time frame: end of 4 week treatment intervention (40 hours of CIMT). Mean (Full Range). Unit: percent time EMG taVNS stimulation

Measure	Custom EMG Triggered Soterix taVNS Stimulation With CIMT Therapy in Lab n = 2
Value	33.33 (3 to 77)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study staff were in daily contact with participants throughout treatment. After the 4 week interventions, we followed up at 3 months up to 4 months post for final assessments.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Soterix taVNS Stimulation Using EMG Sensors	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): The purpose of this trial was to test the feasibility of using EMG to trigger taVNS stimulation. The EMG sensors did not stay in place well for some infants. Additionally, there was a large amount of time and effort required for individual calibration. We met the goal threshold of phase 1 for our EMG sensor to trigger taVNS stimulation. However, the automatic triggering did not continue to work well for subsequent participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 4 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 4 Jul 2025. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jul 2025). 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?

Device Feasibility (time frame: end of 4 week treatment intervention (40 hours of CIMT)). 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 NCT05857527.

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 4 Jul 2025.