Transcranial Magnetic Stimulation Clinical Trial
Official title:
Neuromodulation With rTMS in Dysphagic Patients With Stroke
Verified date | July 2016 |
Source | Taipei Veterans General Hospital, Taiwan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan |
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
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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