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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03048916
Other study ID # NMRPG896021
Secondary ID
Status Completed
Phase N/A
First received February 5, 2017
Last updated February 8, 2017
Start date August 1, 2010
Est. completion date July 31, 2013

Study information

Verified date February 2017
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date July 31, 2013
Est. primary completion date July 31, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
general swallowing therapy
including a session of oral exercises, tactile stimulation, compensatory techniques, swallowing maneuvers that are taught to the participants by a speech therapist.
NMES therapy
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

References & Publications (35)

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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. — View 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. — View 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. — View 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. — View Citation

Ertekin C, Aydogdu I. Neurophysiology of swallowing. Clin Neurophysiol. 2003 Dec;114(12):2226-44. Review. — View 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. Review. — View 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. — View 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. — View Citation

Hägg M, Larsson B. Effects of motor and sensory stimulation in stroke patients with long-lasting dysphagia. Dysphagia. 2004 Fall;19(4):219-30. — View 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. — View 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. — View 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. — View 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 Pt 1):G219-25. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Leelamanit V, Limsakul C, Geater A. Synchronized electrical stimulation in treating pharyngeal dysphagia. Laryngoscope. 2002 Dec;112(12):2204-10. — View 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. — View 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. — View 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. — View Citation

Martin RE, Sessle BJ. The role of the cerebral cortex in swallowing. Dysphagia. 1993;8(3):195-202. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Robbins J, Levin RL. Swallowing after unilateral stroke of the cerebral cortex: preliminary experience. Dysphagia. 1988;3(1):11-7. — View 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. — View Citation

Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. — View Citation

Smithard DG, Smeeton NC, Wolfe CD. Long-term outcome after stroke: does dysphagia matter? Age Ageing. 2007 Jan;36(1):90-4. — View Citation

* Note: There are 35 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline (before intervention), changes from baseline FOIS at 4 weeks
Secondary 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. baseline (before intervention), changes from baseline PAS score at 4 weeks
Secondary 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. baseline (before intervention), changes from baseline FDS score at 4weeks
Secondary 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.
baseline (before intervention), changes from baseline result of 3-Dimensional (3D) structural MRI at 4 weeks
Secondary 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.
baseline (before intervention), changes from baseline result of fMRI at 4 weeks
Secondary 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.
baseline (before intervention), changes from baseline result of diffusion tensor imaging at 4 weeks
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