DysphagiaNCT03048916
Dysphagia After Different Swallowing Therapies
A study testing general swallowing therapy and NMES therapy in people with Dysphagia and Videofluoroscopy, run by Chang Gung Memorial Hospital.
Trial summary
Dysphagia after stroke is associated to increased pulmonary complications and mortality. The swallowing therapies could decrease the pulmonary complications and improve the quality of life after stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Videofluoroscopy, Stroke
- What is being tested?
- general swallowing therapy and NMES therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2010to 31 Jul 2013
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal neurological examination
- no history of stroke
- no active neurological disorder
- a single cerebral hemispheric stroke
- swallowing difficulty: detected by bedside swallow assessment by a physician while admitting to the rehabilitation unit.
- a single brain stem stroke without prior stroke history
- swallowing difficulties: detected by bedside swallow assessment by a physician while admitting to the rehabilitation unit
Who cannot join
- multiple brain lesions due to one episode of stroke
- impaired communication ability due to cognition deficit
- other central or peripheral neurological deficit leading to swallowing difficulty.
- use of an electrically sensitive biomedical device (eg. cardiac pacemaker)
- metal clip in the brain
- pneumonia at the time of enrollment.
About this study
Official title: Acute Stroke Patients With Dysphagia After Different Swallowing Therapies: Videofluoroscopy Findings and Brain Plasticity in Magnetic Resonance Imaging
Dysphagia after stroke is associated to increased pulmonary complications and mortality. The swallowing therapies could decrease the pulmonary complications and improve the quality of life after stroke. The swallowing therapies include dietary modifications, thermal stimulation, compensatory positions, and oropharyngeal muscle stimulation. Most researchers used clinical assessments and videofluoroscopy to evaluate the effect of the swallowing therapies. Some authors performed functional magnetic resonance imaging (fMRI) to investigate the brain neuroactivity during swallowing with tasks in normal adults and unilateral hemispheric stroke patients. The aim of this study is to explore the effect of swallowing therapies not only in clinical swallowing function but also brain plasticity of acute stroke patients with dysphagia by videofluoroscopy and fMRI.
Read the detailed description
In the study, 10 healthy controls and 48 patients with a single and acute hemispheric or brain stem stroke will be enrolled. Both 24 hemispheric and 24 brain stem stroke patients will be divided into 3 groups. General swallowing therapy, oropharyngeal neuromuscular electrical stimulation (NMES), and combined general and NMES therapies will be randomly provided for the 3 groups. Each patient will receive clinical assessment of food oral intake scale, functional dysphagia scale of videofluoroscopy, and brain neuroactivity in fMRI.
The investigators hope to find the benefit of the swallowing therapies both in clinical swallowing function and in brain functional neuroactivity/reorganization after acute stroke. While comparing the 3 swallowing therapies, different functional neuroactivity may be facilitated by different swallowing therapies. Finally, the investigators could also find out the most effective swallowing therapy among the 3 therapies in acute stroke patients with dysphagia according to the findings of videofluoroscopy and fMRI.
- Conditions
- Dysphagia, Videofluoroscopy, Stroke
- Being tested
- general swallowing therapy, NMES therapy
- Keywords
- dysphagia, stroke, magnetic resonance imaging, videofluoroscopy
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general swallowing therapyOther
including a session of oral exercises, tactile stimulation, compensatory techniques, swallowing maneuvers that are taught to the participants by a speech therapist.
NMES therapyOther
he NMES therapy with VitalStim therapeutic device will be done by one physician who is licensed practitioner and certified in use of the VitalStim device. The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS.
| Study group | Role | What they receive |
|---|---|---|
| general swallowing therapy | Other | including:
* oral exercises
* tactile stimulation
* compensatory techniques
* swallowing maneuvers Receives: Other: general swallowing therapy |
| the NMES therapy with VitalStim therapeutic device | Experimental | The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS Receives: Other: NMES therapy |
| : the combined NMES and general swallowing therapies | Active comparator | Not described Receives: Other: general swallowing therapy; Other: NMES therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The functional oral intake scale
Clinical swallowing evaluations: The functional oral intake scale (FOIS) was reported by Crary et al. for presenting the functional oral intake of food and liquid in stroke patients. One physician who is blinded to the therapies will evaluate the FOIS for each participant before and after swallowing treatments.
Measured: baseline (before intervention), changes from baseline FOIS at 4 weeks
Secondary outcomes (5)
8-point penetration-aspiration scale (PAS)
VFS is a standard tool for swallowing disorders. A 8-point penetration-aspiration scale (PAS) is used for observing the event of penetration or aspiration on VFS.
Measured: baseline (before intervention), changes from baseline PAS score at 4 weeks
11-item functional dysphagia scale (FDS)
A 11-item functional dysphagia scale (FDS) of VFS is a sensitive and specific method for quantifying swallowing function in stroke.
Measured: baseline (before intervention), changes from baseline FDS score at 4weeks
3-Dimensional (3D) structural MRI
MR images are obtained using a 3.0-T whole body magnet with a 50- and 23-mT/m gradient strength, and an echo-planar-capable receiver (GE SIGNA EXCITE HD, GE Medical Systems, Milwaukee, US).
A 3-dimensional (3D) structural MRI is acquired for each subject using a T1-weighted gradient echo magnetization prepared rapid gradient echo sequence yielding 124 sagittal slices with a defined voxel size of 1 x 1 x 1.5 mm.
Measured: baseline (before intervention), changes from baseline result of 3-Dimensional (3D) structural MRI at 4 weeks
Function MRI
MR images are obtained using a 3.0-T whole body magnet with a 50- and 23-mT/m gradient strength, and an echo-planar-capable receiver (GE SIGNA EXCITE HD, GE Medical Systems, Milwaukee, US).
The functional images are obtained using an EPI sequence with the following parameters: 33 axial slices, image resolution = 3.75*3.75*4, and TR= 2000 ms.
Measured: baseline (before intervention), changes from baseline result of fMRI at 4 weeks
Diffusion tensor imaging
MR images are obtained using a 3.0-T whole body magnet with a 50- and 23-mT/m gradient strength, and an echo-planar-capable receiver (GE SIGNA EXCITE HD, GE Medical Systems, Milwaukee, US).
An 8 channels diffusion tensor imaging (DTI) acquisition protocol will be used to acquire high resolution DTI, i.e. 2 x 2 x 2 mm3 voxel size. With 13 diffusion encoding directions and number of average of 4, whole brain DTI and high resolution eigenvector field can be acquired within 20 mins.
Measured: baseline (before intervention), changes from baseline result of diffusion tensor imaging at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Aug 2010
- Primary completion31 Jul 2012
- Study completion31 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- 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, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Chi Huang, Bachelor, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048916
- Sponsor's protocol ID
- NMRPG896021
- Status last verified
- Feb 2017
- First submitted
- 5 Feb 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barer DH. The natural history and functional consequences of dysphagia after hemispheric stroke. J Neurol Neurosurg Psychiatry. 1989 Feb;52(2):236-41. doi: 10.1136/jnnp.52.2.236.
PubMed 2564884Meng NH, Wang TG, Lien IN. Dysphagia in patients with brainstem stroke: incidence and outcome. Am J Phys Med Rehabil. 2000 Mar-Apr;79(2):170-5. doi: 10.1097/00002060-200003000-00010.
PubMed 10744192Paciaroni M, Mazzotta G, Corea F, Caso V, Venti M, Milia P, Silvestrelli G, Palmerini F, Parnetti L, Gallai V. Dysphagia following Stroke. Eur Neurol. 2004;51(3):162-7. doi: 10.1159/000077663. Epub 2004 Apr 1.
PubMed 15073441Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
PubMed 16269630Foley N, Teasell R, Salter K, Kruger E, Martino R. Dysphagia treatment post stroke: a systematic review of randomised controlled trials. Age Ageing. 2008 May;37(3):258-64. doi: 10.1093/ageing/afn064.
PubMed 18456790Smithard DG, Smeeton NC, Wolfe CD. Long-term outcome after stroke: does dysphagia matter? Age Ageing. 2007 Jan;36(1):90-4. doi: 10.1093/ageing/afl149. Epub 2006 Dec 15.
PubMed 17172601Goulding R, Bakheit AM. Evaluation of the benefits of monitoring fluid thickness in the dietary management of dysphagic stroke patients. Clin Rehabil. 2000 Apr;14(2):119-24. doi: 10.1191/026921500667340586.
PubMed 10763787Carnaby G, Hankey GJ, Pizzi J. Behavioural intervention for dysphagia in acute stroke: a randomised controlled trial. Lancet Neurol. 2006 Jan;5(1):31-7. doi: 10.1016/S1474-4422(05)70252-0.
PubMed 16361020DePippo KL, Holas MA, Reding MJ, Mandel FS, Lesser ML. Dysphagia therapy following stroke: a controlled trial. Neurology. 1994 Sep;44(9):1655-60. doi: 10.1212/wnl.44.9.1655.
PubMed 7936292Dennis MS, Lewis SC, Warlow C; FOOD Trial Collaboration. Effect of timing and method of enteral tube feeding for dysphagic stroke patients (FOOD): a multicentre randomised controlled trial. Lancet. 2005 Feb 26-Mar 4;365(9461):764-72. doi: 10.1016/S0140-6736(05)17983-5.
PubMed 15733717Hamidon BB, Abdullah SA, Zawawi MF, Sukumar N, Aminuddin A, Raymond AA. A prospective comparison of percutaneous endoscopic gastrostomy and nasogastric tube feeding in patients with acute dysphagic stroke. Med J Malaysia. 2006 Mar;61(1):59-66.
PubMed 16708735Burnett TA, Mann EA, Cornell SA, Ludlow CL. Laryngeal elevation achieved by neuromuscular stimulation at rest. J Appl Physiol (1985). 2003 Jan;94(1):128-34. doi: 10.1152/japplphysiol.00406.2002.
PubMed 12486019Park CL, O'Neill PA, Martin DF. A pilot exploratory study of oral electrical stimulation on swallow function following stroke: an innovative technique. Dysphagia. 1997 Summer;12(3):161-6. doi: 10.1007/PL00009531.
PubMed 9190102Freed ML, Freed L, Chatburn RL, Christian M. Electrical stimulation for swallowing disorders caused by stroke. Respir Care. 2001 May;46(5):466-74.
PubMed 11309186Leelamanit V, Limsakul C, Geater A. Synchronized electrical stimulation in treating pharyngeal dysphagia. Laryngoscope. 2002 Dec;112(12):2204-10. doi: 10.1097/00005537-200212000-00015.
PubMed 12461342
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Stroke Patients With Dysphagia After Different Swallowing Therapies: Videofluoroscopy Findings and Brain Plasticity in Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03048916
- Acronym / sponsor ID
- NMRPG896021
- Conditions
- Dysphagia, Videofluoroscopy, Stroke
- Keywords
- dysphagia, stroke, magnetic resonance imaging, videofluoroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 31 Jul 2012 (actual)
- Study completion
- 31 Jul 2013 (actual)
- First posted
- 9 Feb 2017 (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.
Dysphagia after stroke is associated to increased pulmonary complications and mortality. The swallowing therapies could decrease the pulmonary complications and improve the quality of life after stroke. The swallowing therapies include dietary modifications, thermal stimulation, compensatory positions, and oropharyngeal muscle stimulation. Most researchers used clinical assessments and videofluoroscopy to evaluate the effect of the swallowing therapies. Some authors performed functional magnetic resonance imaging (fMRI) to investigate the brain neuroactivity during swallowing with tasks in normal adults and unilateral hemispheric stroke patients. The aim of this study is to explore the effect of swallowing therapies not only in clinical swallowing function but also brain plasticity of acute stroke patients with dysphagia by videofluoroscopy and fMRI.
Detailed description
In the study, 10 healthy controls and 48 patients with a single and acute hemispheric or brain stem stroke will be enrolled. Both 24 hemispheric and 24 brain stem stroke patients will be divided into 3 groups. General swallowing therapy, oropharyngeal neuromuscular electrical stimulation (NMES), and combined general and NMES therapies will be randomly provided for the 3 groups. Each patient will receive clinical assessment of food oral intake scale, functional dysphagia scale of videofluoroscopy, and brain neuroactivity in fMRI.
The investigators hope to find the benefit of the swallowing therapies both in clinical swallowing function and in brain functional neuroactivity/reorganization after acute stroke. While comparing the 3 swallowing therapies, different functional neuroactivity may be facilitated by different swallowing therapies. Finally, the investigators could also find out the most effective swallowing therapy among the 3 therapies in acute stroke patients with dysphagia according to the findings of videofluoroscopy and fMRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| general swallowing therapy | Other | Other: general swallowing therapyincluding: * oral exercises * tactile stimulation * compensatory techniques * swallowing maneuvers |
| the NMES therapy with VitalStim therapeutic device | Experimental | Other: NMES therapyThe placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS |
| : the combined NMES and general swallowing therapies | Active comparator | Other: general swallowing therapy, Other: NMES therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- normal neurological examination
- no history of stroke
- no active neurological disorder
- a single cerebral hemispheric stroke
- swallowing difficulty: detected by bedside swallow assessment by a physician while admitting to the rehabilitation unit.
Key exclusion criteria (6 listed)
- multiple brain lesions due to one episode of stroke
- impaired communication ability due to cognition deficit
- other central or peripheral neurological deficit leading to swallowing difficulty.
- use of an electrically sensitive biomedical device (eg. cardiac pacemaker)
- metal clip in the brain
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 |
|---|---|---|
| general swallowing therapyincluding a session of oral exercises, tactile stimulation, compensatory techniques, swallowing maneuvers that are taught to the participants by a speech therapist. | Other | : the combined NMES and general swallowing therapies, general swallowing therapy |
| NMES therapyhe NMES therapy with VitalStim therapeutic device will be done by one physician who is licensed practitioner and certified in use of the VitalStim device. The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS. | Other | : the combined NMES and general swallowing therapies, the NMES therapy with VitalStim therapeutic device |
Primary outcome
The functional oral intake scale
Time frame: baseline (before intervention), changes from baseline FOIS at 4 weeks
Clinical swallowing evaluations: The functional oral intake scale (FOIS) was reported by Crary et al. for presenting the functional oral intake of food and liquid in stroke patients. One physician who is blinded to the therapies will evaluate the FOIS for each participant before and after swallowing treatments.
5 secondary outcomes
8-point penetration-aspiration scale (PAS)
Time frame: baseline (before intervention), changes from baseline PAS score at 4 weeks
11-item functional dysphagia scale (FDS)
Time frame: baseline (before intervention), changes from baseline FDS score at 4weeks
3-Dimensional (3D) structural MRI
Time frame: baseline (before intervention), changes from baseline result of 3-Dimensional (3D) structural MRI at 4 weeks
Function MRI
Time frame: baseline (before intervention), changes from baseline result of fMRI at 4 weeks
Diffusion tensor imaging
Time frame: baseline (before intervention), changes from baseline result of diffusion tensor imaging at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Background: PubMed 2564884Barer DH. The natural history and functional consequences of dysphagia after hemispheric stroke. J Neurol Neurosurg Psychiatry. 1989 Feb;52(2):236-41. doi: 10.1136/jnnp.52.2.236.
- Background: PubMed 10744192Meng NH, Wang TG, Lien IN. Dysphagia in patients with brainstem stroke: incidence and outcome. Am J Phys Med Rehabil. 2000 Mar-Apr;79(2):170-5. doi: 10.1097/00002060-200003000-00010.
- Background: PubMed 15073441Paciaroni M, Mazzotta G, Corea F, Caso V, Venti M, Milia P, Silvestrelli G, Palmerini F, Parnetti L, Gallai V. Dysphagia following Stroke. Eur Neurol. 2004;51(3):162-7. doi: 10.1159/000077663. Epub 2004 Apr 1.
- Background: PubMed 16269630Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
- Background: PubMed 18456790Foley N, Teasell R, Salter K, Kruger E, Martino R. Dysphagia treatment post stroke: a systematic review of randomised controlled trials. Age Ageing. 2008 May;37(3):258-64. doi: 10.1093/ageing/afn064.
- Background: PubMed 17172601Smithard DG, Smeeton NC, Wolfe CD. Long-term outcome after stroke: does dysphagia matter? Age Ageing. 2007 Jan;36(1):90-4. doi: 10.1093/ageing/afl149. Epub 2006 Dec 15.
- Background: PubMed 10763787Goulding R, Bakheit AM. Evaluation of the benefits of monitoring fluid thickness in the dietary management of dysphagic stroke patients. Clin Rehabil. 2000 Apr;14(2):119-24. doi: 10.1191/026921500667340586.
- Background: PubMed 16361020Carnaby G, Hankey GJ, Pizzi J. Behavioural intervention for dysphagia in acute stroke: a randomised controlled trial. Lancet Neurol. 2006 Jan;5(1):31-7. doi: 10.1016/S1474-4422(05)70252-0.
- Background: PubMed 7936292DePippo KL, Holas MA, Reding MJ, Mandel FS, Lesser ML. Dysphagia therapy following stroke: a controlled trial. Neurology. 1994 Sep;44(9):1655-60. doi: 10.1212/wnl.44.9.1655.
- Background: PubMed 15733717Dennis MS, Lewis SC, Warlow C; FOOD Trial Collaboration. Effect of timing and method of enteral tube feeding for dysphagic stroke patients (FOOD): a multicentre randomised controlled trial. Lancet. 2005 Feb 26-Mar 4;365(9461):764-72. doi: 10.1016/S0140-6736(05)17983-5.
- Background: PubMed 16708735Hamidon BB, Abdullah SA, Zawawi MF, Sukumar N, Aminuddin A, Raymond AA. A prospective comparison of percutaneous endoscopic gastrostomy and nasogastric tube feeding in patients with acute dysphagic stroke. Med J Malaysia. 2006 Mar;61(1):59-66.
- Background: PubMed 12486019Burnett TA, Mann EA, Cornell SA, Ludlow CL. Laryngeal elevation achieved by neuromuscular stimulation at rest. J Appl Physiol (1985). 2003 Jan;94(1):128-34. doi: 10.1152/japplphysiol.00406.2002.
- Individual participant dataSharing planned: No
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Dysphagia
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.
Yu Chi Huang, Bachelor principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing general swallowing therapy and NMES therapy in people with Dysphagia and Videofluoroscopy, run by Chang Gung Memorial Hospital.
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: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The functional oral intake scale (time frame: baseline (before intervention), changes from baseline FOIS at 4 weeks). 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 NCT03048916, which also lists 35 linked publications.
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 9 Feb 2017; AzTrials last refreshed its copy on 31 Oct 2026.