Repetitive Transcranial Magnetic Stimulation on Dysphagia in the Stroke Patient

Taipei Medical University

Status: Enrolling

Conditions: Dysphagia; Stroke; Repetitive Transcranial Magnetic Stimulation

Treatments: Device: Repetitive Transcranial Magnetic Stimulation; Device: Neuromuscular electrical stimulation combined with conventional swallowing training

Study type: Interventional

Funder types: Other

Identifiers

NCT05861596

N201912080

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Group A

Experimental group

Description:

Conscript 10 individuals, every individual will receive 20 mins of repetitive transcranial magnetic stimulation and 30 min NMES combined with conventional swallowing therapy, 5 times per week, lasting for 2 weeks.

Treatment:

Device: Neuromuscular electrical stimulation combined with conventional swallowing training

Device: Repetitive Transcranial Magnetic Stimulation

Group B

Sham Comparator group

Description:

Conscript 10 individuals, every individual will receive sham repetitive transcranial magnetic stimulation and 30 min NMES combined with conventional swallowing therapy, 5 times per week, lasting for 2 weeks.

Treatment:

Device: Neuromuscular electrical stimulation combined with conventional swallowing training