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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02893033
Other study ID # 2014-07-007C
Secondary ID
Status Completed
Phase N/A
First received August 26, 2016
Last updated June 19, 2017
Start date August 2014
Est. completion date August 2015

Study information

Verified date July 2016
Source Taipei Veterans General Hospital, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The patients with chronic dysphagia secondary to first-ever stroke were randomly assigned to 2 groups: Group A: sham stimulation for 10 minutes , Group B: real rTMS for 10 minutes. rTMS conditioning: daily rTMS 10 min for 10 days. Assessments: 1. videofluoroscopy,2.Functional outcome swallowing scale (3 scales). 3. MEP measurements


Description:

While the reflex component of swallowing depends on swallowing centres in the brainstem, initiation of swallowing is a voluntary action that involves the integrity of motor areas of the cerebral cortex. Oropharyngeal dysphagia occurs in more than 50% of stroke patients. Aspiration pneumonia occurs in up to 20% of acute stroke patients and is a major cause of mortality after discharge. Oropharyngeal dysphagia is both underestimated and underdiagnosed as a cause of major nutritional and respiratory complications in stroke patients. Recently, transcranial magnetic stimulation (TMS) has been used to study the cortical input to swallowing control and has revealed that the topographic representation of esophageal motor function in the human cerebral cortex is bilateral but with consistent interhemispheric asymmetry unrelated to handedness.

In a number of recent studies, poststroke motor and dysphagia performance has been improved after daily treatment sessions with repetitive TMS (rTMS) using an excitatory frequency in patients with hemispheric ischaemic stroke due to occlusion of territories of the middle cerebral artery. Our hypothesis was that rTMS would facilitate dysphagia recovery.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

1. a diagnosis of stroke related dysphagia

2. no concurrent neurodegenerative or dementia history

3. an absence of TMS contraindications.

Exclusion Criteria:

- arrythmia, epilepsy, infection, hyperglycemia, pacemaker or implants, external ventricular drain or ventriculoperitoneal shunt

Study Design


Related Conditions & MeSH terms

  • Transcranial Magnetic Stimulation

Intervention

Device:
repetitive transcranial magnetic stimulation
rTMS

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

References & Publications (2)

Park JW, Oh JC, Lee JW, Yeo JS, Ryu KH. The effect of 5Hz high-frequency rTMS over contralesional pharyngeal motor cortex in post-stroke oropharyngeal dysphagia: a randomized controlled study. Neurogastroenterol Motil. 2013 Apr;25(4):324-e250. doi: 10.1111/nmo.12063. Epub 2012 Dec 23. — View Citation

Rofes L, Vilardell N, Clavé P. Post-stroke dysphagia: progress at last. Neurogastroenterol Motil. 2013 Apr;25(4):278-82. doi: 10.1111/nmo.12112. Epub 2013 Mar 11. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary functional outcome points of Australian Therapy Outcome Measures—the Swallowing scale as assessed by a clinical therapist prior to treatment (baseline), on the next day after the 2 weeks treatment completion
Secondary videofluoroscopy points of Penetration-Aspiration Scale as assessed by videofluoroscopy prior to treatment (baseline), on the next day after the 2 weeks treatment completion
Secondary cricopharyngeal motor evoked potentials amplitude and latency measured by cricopharyngeal motor evoked potentials prior to treatment (baseline), on the next day after the 2 weeks treatment completion
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