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Completed

NCT Number: NCT02893033

Neuromodulation With rTMS in Dysphagic Patients With Stroke

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a diagnosis of stroke related dysphagia
  • no concurrent neurodegenerative or dementia history
  • an absence of TMS contraindications.

Exclusion criteria

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

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

rTMS

Primary outcomes

  1. functional outcome

    Time frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion

    points of Australian Therapy Outcome Measures-the Swallowing scale as assessed by a clinical therapist

Secondary outcomes

  1. videofluoroscopy

    Time frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion

    points of Penetration-Aspiration Scale as assessed by videofluoroscopy

  2. cricopharyngeal motor evoked potentials

    Time frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion

    amplitude and latency measured by cricopharyngeal motor evoked potentials

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 8, 2016
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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