Neuromodulation With rTMS in Dysphagic Patients With Stroke

Not Applicable

Completed

• Conditions: Transcranial Magnetic Stimulation
• Interventions: Device: repetitive transcranial magnetic stimulation

• Registration Number: NCT02893033
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-07
• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real stimulation	repetitive transcranial magnetic stimulation	Real repetitive transcranial magnetic stimulation + swallowing training
Sham stimulation	repetitive transcranial magnetic stimulation	Sham repetitive transcranial magnetic stimulation + swallowing training

Primary Outcome Measures

Name	Time	Method
functional outcome	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 Outcome Measures

Name	Time	Method
videofluoroscopy	prior to treatment (baseline), on the next day after the 2 weeks treatment completion	points of Penetration-Aspiration Scale as assessed by videofluoroscopy
cricopharyngeal motor evoked potentials	prior to treatment (baseline), on the next day after the 2 weeks treatment completion	amplitude and latency measured by cricopharyngeal motor evoked potentials