Clinical trial NCT05861596: Repetitive Transcranial Magnetic Stimulation on Dysphagia in the Stroke Patient
Official title: Effects of Repetitive Transcranial Magnetic Stimulation on Dysphagia in Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Dysphagia
Repetitive Transcranial Magnetic Stimulation
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants suffered from acute stroke with dysphagia in single hospital who were determined by CT/MRI and clinical evaluation. Current project will recruit participants and randomize into two groups.One group will receive NMES, traditional swallowing therapy and rTMS therapy five times per week for 2 weeks ; Another group will receive NMES and traditional swallowing therapy with shame rTMS five times per week for 2 weeks. FEES and SSA were used for evaluated swallowing function before the therapy and after 2 weeks therapy.

Detailed description: Participants suffered from acute stroke with dysphagia in single hospital who were determined by CT/MRI and clinical evaluation. The aim of this study is to compare the effects of rTMS, NMES and conventional swallowing therapy to those of sham rTMS, NMES and conventional swallowing therapy. One group will receive NMES, to sham One group will receive NMES,traditional swallowing therapy and rTMS therapy five times per week for 2 weeks ; Another group will receive NMES and traditional swallowing therapy with shame rTMS five times per week for 2 weeks. MEP character, FEES, degrees of dysphagia, FOIS, and SSA were used for evaluated swallowing function before the therapy and after 2 weeks therapy.

Eligibility criteria: Inclusion Criteria:

1. stroke
2. Onset time at least for one week，area not be limited.
3. Patient was first time stroke patient without obvious infection condition.
4. Patients with dysphagia in the stroke who were diagnosed by neurologist and CT/MRI in our institute. Patient was clear with adequate motivation and could cooperate the whole therapy and FEES evaluation.

Exclusion Criteria:

1. Lower motor neuron disease, such as autonomic dysreflexia, facial palsy, hyhoid muscle denervation.
2. Mental status unstable, mental retardation, schizophrenia, bipolar disease were be excluded.
3. Metal implantation of head, ventroperotoneal shunt or any seizure history, pacemaker, as well as head and neck cancer.
4. Allergy to specific subjects
5. Cognition impairment
6. Alcohol or drugs abuse
7. Afraid of the noise of rTMS.

Primary outcomes:
measure: Change from baseline in Fiberoptic Endoscopic Examination of Swallowing (FEES) at 2 weeks
timeFrame: one day before intervention, 1 day after intervention
measure: Change from baseline in The Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) at 2 weeks
timeFrame: one day before intervention, 1 day after intervention
measure: Change of baseline Standardized Swallowing Assessment (SSA) at 2 weeks
timeFrame: one day before intervention, 1 day after intervention
measure: Change of baseline Latency of Motor evoked potentials (MEP) at 2 weeks
timeFrame: one day before intervention, 1 day after intervention
measure: Change of baseline Amplitude of Motor evoked potentials (MEP) at 2 weeks
timeFrame: one day before intervention, 1 day after intervention.
Secondary outcomes:
measure: Change of baseline Degree of dysphagia at 2 weeks
timeFrame: one day before intervention, 1 day after intervention
measure: Change of Functional Oral Intake Scale (FOIS) at 2 weeks
timeFrame: one day before intervention, 1 day after intervention
measure: Change of baseline modified water swallowing test at 2 weeks
timeFrame: one day before intervention, 1 day after intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital
name: Chien-Hung Lai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: