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Dysphagia After Different Swallowing Therapies

Primary Purpose

Dysphagia, Videofluoroscopy, Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
general swallowing therapy
NMES therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring dysphagia, stroke, magnetic resonance imaging, videofluoroscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria of normal controls:

  • normal neurological examination
  • no history of stroke
  • no active neurological disorder

Inclusion criteria of hemispheric stroke patients:

  • a single cerebral hemispheric stroke
  • swallowing difficulty: detected by bedside swallow assessment by a physician while admitting to the rehabilitation unit.

Inclusion criteria of these brain stem stroke patients:

  • 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

Exclusion criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Experimental

    Active Comparator

    Arm Label

    general swallowing therapy

    the NMES therapy with VitalStim therapeutic device

    : the combined NMES and general swallowing therapies

    Arm Description

    including: oral exercises tactile stimulation compensatory techniques swallowing maneuvers

    The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    February 5, 2017
    Last Updated
    February 8, 2017
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03048916
    Brief Title
    Dysphagia After Different Swallowing Therapies
    Official Title
    Acute Stroke Patients With Dysphagia After Different Swallowing Therapies: Videofluoroscopy Findings and Brain Plasticity in Magnetic Resonance Imaging
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2010 (Actual)
    Primary Completion Date
    July 31, 2012 (Actual)
    Study Completion Date
    July 31, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysphagia, Videofluoroscopy, Stroke
    Keywords
    dysphagia, stroke, magnetic resonance imaging, videofluoroscopy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    general swallowing therapy
    Arm Type
    Other
    Arm Description
    including: oral exercises tactile stimulation compensatory techniques swallowing maneuvers
    Arm Title
    the NMES therapy with VitalStim therapeutic device
    Arm Type
    Experimental
    Arm Description
    The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS
    Arm Title
    : the combined NMES and general swallowing therapies
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    general swallowing therapy
    Intervention Description
    including a session of oral exercises, tactile stimulation, compensatory techniques, swallowing maneuvers that are taught to the participants by a speech therapist.
    Intervention Type
    Other
    Intervention Name(s)
    NMES therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The functional oral intake scale
    Description
    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.
    Time Frame
    baseline (before intervention), changes from baseline FOIS at 4 weeks
    Secondary Outcome Measure Information:
    Title
    8-point penetration-aspiration scale (PAS)
    Description
    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.
    Time Frame
    baseline (before intervention), changes from baseline PAS score at 4 weeks
    Title
    11-item functional dysphagia scale (FDS)
    Description
    A 11-item functional dysphagia scale (FDS) of VFS is a sensitive and specific method for quantifying swallowing function in stroke.
    Time Frame
    baseline (before intervention), changes from baseline FDS score at 4weeks
    Title
    3-Dimensional (3D) structural MRI
    Description
    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.
    Time Frame
    baseline (before intervention), changes from baseline result of 3-Dimensional (3D) structural MRI at 4 weeks
    Title
    Function MRI
    Description
    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.
    Time Frame
    baseline (before intervention), changes from baseline result of fMRI at 4 weeks
    Title
    Diffusion tensor imaging
    Description
    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.
    Time Frame
    baseline (before intervention), changes from baseline result of diffusion tensor imaging at 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria of normal controls: normal neurological examination no history of stroke no active neurological disorder Inclusion criteria of hemispheric stroke patients: a single cerebral hemispheric stroke swallowing difficulty: detected by bedside swallow assessment by a physician while admitting to the rehabilitation unit. Inclusion criteria of these brain stem stroke patients: 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 Exclusion criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu Chi Huang, Bachelor
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    2564884
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10744192
    Citation
    Meng 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.
    Results Reference
    background
    PubMed Identifier
    15073441
    Citation
    Paciaroni 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.
    Results Reference
    background
    PubMed Identifier
    16269630
    Citation
    Martino 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.
    Results Reference
    background
    PubMed Identifier
    18456790
    Citation
    Foley 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.
    Results Reference
    background
    PubMed Identifier
    17172601
    Citation
    Smithard 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.
    Results Reference
    background
    PubMed Identifier
    10763787
    Citation
    Goulding 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.
    Results Reference
    background
    PubMed Identifier
    16361020
    Citation
    Carnaby 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.
    Results Reference
    background
    PubMed Identifier
    7936292
    Citation
    DePippo 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.
    Results Reference
    background
    PubMed Identifier
    15733717
    Citation
    Dennis 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.
    Results Reference
    background
    PubMed Identifier
    16708735
    Citation
    Hamidon 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.
    Results Reference
    background
    PubMed Identifier
    12486019
    Citation
    Burnett 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.
    Results Reference
    background
    PubMed Identifier
    9190102
    Citation
    Park 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.
    Results Reference
    background
    PubMed Identifier
    11309186
    Citation
    Freed ML, Freed L, Chatburn RL, Christian M. Electrical stimulation for swallowing disorders caused by stroke. Respir Care. 2001 May;46(5):466-74.
    Results Reference
    background
    PubMed Identifier
    12461342
    Citation
    Leelamanit 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.
    Results Reference
    background
    PubMed Identifier
    10590405
    Citation
    Ludlow CL, Bielamowicz S, Daniels Rosenberg M, Ambalavanar R, Rossini K, Gillespie M, Hampshire V, Testerman R, Erickson D, Carraro U. Chronic intermittent stimulation of the thyroarytenoid muscle maintains dynamic control of glottal adduction. Muscle Nerve. 2000 Jan;23(1):44-57. doi: 10.1002/(sici)1097-4598(200001)23:13.0.co;2-e.
    Results Reference
    background
    PubMed Identifier
    15667056
    Citation
    Hagg M, Larsson B. Effects of motor and sensory stimulation in stroke patients with long-lasting dysphagia. Dysphagia. 2004 Fall;19(4):219-30. doi: 10.1007/s00455-004-0016-3.
    Results Reference
    background
    PubMed Identifier
    8359039
    Citation
    Martin RE, Sessle BJ. The role of the cerebral cortex in swallowing. Dysphagia. 1993;8(3):195-202. doi: 10.1007/BF01354538.
    Results Reference
    background
    PubMed Identifier
    10918049
    Citation
    Hamdy S, Rothwell JC, Aziz Q, Thompson DG. Organization and reorganization of human swallowing motor cortex: implications for recovery after stroke. Clin Sci (Lond). 2000 Aug;99(2):151-7.
    Results Reference
    background
    PubMed Identifier
    14652082
    Citation
    Ertekin C, Aydogdu I. Neurophysiology of swallowing. Clin Neurophysiol. 2003 Dec;114(12):2226-44. doi: 10.1016/s1388-2457(03)00237-2.
    Results Reference
    background
    PubMed Identifier
    9291902
    Citation
    Hamdy S, Aziz Q, Rothwell JC, Crone R, Hughes D, Tallis RC, Thompson DG. Explaining oropharyngeal dysphagia after unilateral hemispheric stroke. Lancet. 1997 Sep 6;350(9079):686-92. doi: 10.1016/S0140-6736(97)02068-0.
    Results Reference
    background
    PubMed Identifier
    9797365
    Citation
    Hamdy S, Aziz Q, Rothwell JC, Power M, Singh KD, Nicholson DA, Tallis RC, Thompson DG. Recovery of swallowing after dysphagic stroke relates to functional reorganization in the intact motor cortex. Gastroenterology. 1998 Nov;115(5):1104-12. doi: 10.1016/s0016-5085(98)70081-2.
    Results Reference
    background
    PubMed Identifier
    8898748
    Citation
    Hamdy S, Aziz Q, Rothwell JC, Singh KD, Barlow J, Hughes DG, Tallis RC, Thompson DG. The cortical topography of human swallowing musculature in health and disease. Nat Med. 1996 Nov;2(11):1217-24. doi: 10.1038/nm1196-1217.
    Results Reference
    background
    PubMed Identifier
    10195111
    Citation
    Hamdy S, Rothwell JC, Aziz Q, Singh KD, Thompson DG. Long-term reorganization of human motor cortex driven by short-term sensory stimulation. Nat Neurosci. 1998 May;1(1):64-8. doi: 10.1038/264.
    Results Reference
    background
    PubMed Identifier
    3248391
    Citation
    Robbins J, Levin RL. Swallowing after unilateral stroke of the cerebral cortex: preliminary experience. Dysphagia. 1988;3(1):11-7. doi: 10.1007/BF02406275. No abstract available.
    Results Reference
    background
    PubMed Identifier
    19515639
    Citation
    Li S, Luo C, Yu B, Yan B, Gong Q, He C, He L, Huang X, Yao D, Lui S, Tang H, Chen Q, Zeng Y, Zhou D. Functional magnetic resonance imaging study on dysphagia after unilateral hemispheric stroke: a preliminary study. J Neurol Neurosurg Psychiatry. 2009 Dec;80(12):1320-9. doi: 10.1136/jnnp.2009.176214. Epub 2009 Jun 9.
    Results Reference
    background
    PubMed Identifier
    8259895
    Citation
    Robbins J, Levine RL, Maser A, Rosenbek JC, Kempster GB. Swallowing after unilateral stroke of the cerebral cortex. Arch Phys Med Rehabil. 1993 Dec;74(12):1295-300. doi: 10.1016/0003-9993(93)90082-l.
    Results Reference
    background
    PubMed Identifier
    10409170
    Citation
    Hamdy S, Mikulis DJ, Crawley A, Xue S, Lau H, Henry S, Diamant NE. Cortical activation during human volitional swallowing: an event-related fMRI study. Am J Physiol. 1999 Jul;277(1):G219-25. doi: 10.1152/ajpgi.1999.277.1.G219.
    Results Reference
    background
    PubMed Identifier
    10499047
    Citation
    Mosier K, Patel R, Liu WC, Kalnin A, Maldjian J, Baredes S. Cortical representation of swallowing in normal adults: functional implications. Laryngoscope. 1999 Sep;109(9):1417-23. doi: 10.1097/00005537-199909000-00011.
    Results Reference
    background
    PubMed Identifier
    10512240
    Citation
    Mosier KM, Liu WC, Maldjian JA, Shah R, Modi B. Lateralization of cortical function in swallowing: a functional MR imaging study. AJNR Am J Neuroradiol. 1999 Sep;20(8):1520-6.
    Results Reference
    background
    PubMed Identifier
    11171617
    Citation
    Kern MK, Jaradeh S, Arndorfer RC, Shaker R. Cerebral cortical representation of reflexive and volitional swallowing in humans. Am J Physiol Gastrointest Liver Physiol. 2001 Mar;280(3):G354-60. doi: 10.1152/ajpgi.2001.280.3.G354.
    Results Reference
    background
    PubMed Identifier
    11160524
    Citation
    Martin RE, Goodyear BG, Gati JS, Menon RS. Cerebral cortical representation of automatic and volitional swallowing in humans. J Neurophysiol. 2001 Feb;85(2):938-50. doi: 10.1152/jn.2001.85.2.938.
    Results Reference
    background
    PubMed Identifier
    10450023
    Citation
    O'Donoghue S, Bagnall A. Videofluoroscopic evaluation in the assessment of swallowing disorders in paediatric and adult populations. Folia Phoniatr Logop. 1999 Jul-Oct;51(4-5):158-71. doi: 10.1159/000021494.
    Results Reference
    background
    PubMed Identifier
    8721066
    Citation
    Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
    Results Reference
    background
    PubMed Identifier
    11346847
    Citation
    Han TR, Paik NJ, Park JW. Quantifying swallowing function after stroke: A functional dysphagia scale based on videofluoroscopic studies. Arch Phys Med Rehabil. 2001 May;82(5):677-82. doi: 10.1053/apmr.2001.21939.
    Results Reference
    background

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