DysphagiaNCT02007759
Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
A study testing VitalStim in people with Dysphagia, run by Sanford Health at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if the use of Neuromuscular Electrical Stimulation (NMES) will provide a more efficient method of treating neonates with dysfunctional oral feeding such as dysphagia. Read more about this study
- Who is it for?
- Ages 36 to 42 weeks
- Conditions the study is for
- Dysphagia
- What is being tested?
- VitalStim
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jul 2016
- 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 36 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female.
- Meet diagnostic criteria for dysphagia symptoms using the NOMAS and a VFSS.
- Infants with intraventricular hemorrhage (IVH) and hypoxic events can be included.
- Infants taking less than 5-10% of target volume by mouth between the ages of 36-42 weeks PCA.
- Multiple swallows to clear bolus following suck that includes a desaturation <80% and bradycardia <80 bpm.
- Apnea spells during feeds.
- Aspiration or penetration by VFSS
Who cannot join
- Known neurologic or neurodegenerative disorders.
- Chromosomal anomalies and syndromes.
- Cleft lip or palate.
- Birth defects.
- Unresolved cutaneous rash at the area of electrode placement.
- Medical condition that is a contraindication to NMES.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanford USD Medical Center
Sioux Falls, South Dakota, 57117
About this study
Official title: Randomized Treatment of Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
The purpose of this study is to evaluate if the use of Neuromuscular Electrical Stimulation (NMES) will provide a more efficient method of treating neonates with dysfunctional oral feeding such as dysphagia. This study will attempt to determine if NMES applied to neonates at 36-42 weeks post-conception age (PCA) will decrease the need for nasogastric tubes (NG) and gastrostomy tubes (G-TUBE). Increase the rate at which these neonates complete full oral feeds, improve their swallowing skills, increase oral intake of calories, and gain weight.
- Conditions
- Dysphagia
- Being tested
- VitalStim, Sham VitalStim
- Keywords
- Dysphagia, neuromuscular electrical stimulation, NMES, Neonates, Vitalstim
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalStimDevice
This group will receive active VitalStim treatment.
Sham VitalStimDevice
This group will receive a sham VitalStim intervention.
| Study group | Role | What they receive |
|---|---|---|
| VitalStim | Experimental | This group will be assigned to the active VitalStim unit. Receives: Device: VitalStim |
| Sham VitalStim | Sham comparator | This group will be assigned to the sham VitalStim unit. Receives: Device: Sham VitalStim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in G-tube rate insertions for the treatment grouped compared to the sham group.
Measured: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
Increased percent of subjects towards achieving full oral feedings earlier in the subject's dysphagia treatment.
Measured: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
Increase the amount of formula volume taken at feedings from beginning to end of study.
Measured: 2 weeks
Earlier NG tube removal for the treatment group compared to the control group.
Measured: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
Secondary outcomes (6)
Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet.
Measured: 2 weeks
Decrease spells with oral feeds over the course of the study.
Measured: 2 weeks
Allow for healthy weight gain via improved feedings.
Measured: 2 weeks
Increase the caloric intake orally.
Measured: 2 weeks
Decrease the oxygen requirement before and after study.
Measured: 2 weeks
Decrease inpatient length of stay.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Difficulty with recruiting patients; poor quality of EMG
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akram Khan, MD, Principal investigator, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007759
- Sponsor's protocol ID
- SH NMES for Dysphagia
- Status last verified
- Sep 2016
- First submitted
- 14 Oct 2013
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Treatment of Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
- ClinicalTrials.gov ID
- NCT02007759
- Acronym / sponsor ID
- SH NMES for Dysphagia
- Conditions
- Dysphagia
- Keywords
- Dysphagia, neuromuscular electrical stimulation, NMES, Neonates, Vitalstim
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruiting patients; poor quality of EMG
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Dec 2013 (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 purpose of this study is to evaluate if the use of Neuromuscular Electrical Stimulation (NMES) will provide a more efficient method of treating neonates with dysfunctional oral feeding such as dysphagia. This study will attempt to determine if NMES applied to neonates at 36-42 weeks post-conception age (PCA) will decrease the need for nasogastric tubes (NG) and gastrostomy tubes (G-TUBE). Increase the rate at which these neonates complete full oral feeds, improve their swallowing skills, increase oral intake of calories, and gain weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VitalStim | Experimental | Device: VitalStimThis group will be assigned to the active VitalStim unit. |
| Sham VitalStim | Sham comparator | Device: Sham VitalStimThis group will be assigned to the sham VitalStim unit. |
Who may qualify
- Ages
- 36 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male or female.
- Meet diagnostic criteria for dysphagia symptoms using the NOMAS and a VFSS.
- Infants with intraventricular hemorrhage (IVH) and hypoxic events can be included.
- Infants taking less than 5-10% of target volume by mouth between the ages of 36-42 weeks PCA.
- Multiple swallows to clear bolus following suck that includes a desaturation <80% and bradycardia <80 bpm.
Key exclusion criteria (6 listed)
- Known neurologic or neurodegenerative disorders.
- Chromosomal anomalies and syndromes.
- Cleft lip or palate.
- Birth defects.
- Unresolved cutaneous rash at the area of electrode placement.
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 |
|---|---|---|
| VitalStimThis group will receive active VitalStim treatment. | Device | VitalStim |
| Sham VitalStimThis group will receive a sham VitalStim intervention. | Device | Sham VitalStim |
Primary outcome
Reduction in G-tube rate insertions for the treatment grouped compared to the sham group.
Time frame: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
Increased percent of subjects towards achieving full oral feedings earlier in the subject's dysphagia treatment.
Time frame: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
Increase the amount of formula volume taken at feedings from beginning to end of study.
Time frame: 2 weeks
Earlier NG tube removal for the treatment group compared to the control group.
Time frame: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
6 secondary outcomes
Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet.
Time frame: 2 weeks
Decrease spells with oral feeds over the course of the study.
Time frame: 2 weeks
Allow for healthy weight gain via improved feedings.
Time frame: 2 weeks
Increase the caloric intake orally.
Time frame: 2 weeks
Decrease the oxygen requirement before and after study.
Time frame: 2 weeks
Decrease inpatient length of stay.
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Difficulty with recruiting patients; poor quality of EMG). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
Related trials for Dysphagia
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
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.
Akram Khan, MD principal investigator
Sanford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VitalStim in people with Dysphagia, run by Sanford Health 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 7 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 18 Jul 2017. 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?
The study was stopped early (reason given: Difficulty with recruiting patients; poor quality of EMG). 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?
Reduction in G-tube rate insertions for the treatment grouped compared to the sham group. (time frame: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks). The study lists 4 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 18 Jul 2017.