NCT05861596

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

January 19, 2023

Last Update Submit

May 16, 2023

Conditions

StrokeDysphagiaRepetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (5)

  • Change from baseline in Fiberoptic Endoscopic Examination of Swallowing (FEES) at 2 weeks

    In this study, FEES is executed before and after intervention. The assessment of FEES is as follows. Hyodo-score: for predicting aspiration with moderate sensitivity and high specificity. This method consists of four parameters; These four parameters are each scored 0-3 on a 4 point scale (0; normal, 1; mildly impaired, 2; moderately impaired, 3; severely impaired). The Hyodo score is expressed as the sum of scores for each of the four parameters, ranging 0- 12. Patients with a score of less than 5 were assessed as having normal swallowing function. Patients with a score of more than 8 had severe swallowing dysfunction and would not be allowed any oral intake.

    one day before intervention, 1 day after intervention

  • Change from baseline in The Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) at 2 weeks

    The Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS): Stroke-related dysphagia was divided into a six-point FEDSS with 1 score for the best and 6 scores for the worst.

    one day before intervention, 1 day after intervention

  • Change of baseline Standardized Swallowing Assessment (SSA) at 2 weeks

    In this study, SSA was executed before and after intervention. SSA is a standard of universal screening of all stroke patients within 24 hours of admission. And SSA comprises three sections and was designed to terminate if a problem was encountered. The first section checked whether the patient was physically capable of screening; sections 2 and 3 comprised the main screening test. Volitional cough, saliva control, oral motor dexterity, respiratory compromise and phonation were first evaluated; if no problems were elicited, the ability to swallow water was observed.

    one day before intervention, 1 day after intervention

  • Change of baseline Latency of Motor evoked potentials (MEP) at 2 weeks

    Onset latency of MEP, The latency, however, may provide information about the stress in damaged motor pathways.

    one day before intervention, 1 day after intervention

  • Change of baseline Amplitude of Motor evoked potentials (MEP) at 2 weeks

    Onset to peak amplitude of Motor evoked potentials (MEP).The amplitude of motor evoked potentials (MEPs) elicited by transcranial magnetic stimulation (TMS) is a common yet highly variable measure of corticospinal excitability.

    one day before intervention, 1 day after intervention.

Secondary Outcomes (3)

  • Change of baseline Degree of dysphagia at 2 weeks

    one day before intervention, 1 day after intervention

  • Change of Functional Oral Intake Scale (FOIS) at 2 weeks

    one day before intervention, 1 day after intervention

  • Change of baseline modified water swallowing test at 2 weeks

    one day before intervention, 1 day after intervention

Study Arms (2)

Group A

EXPERIMENTAL

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.

Device: Repetitive Transcranial Magnetic StimulationDevice: Neuromuscular electrical stimulation combined with conventional swallowing training

Group B

SHAM COMPARATOR

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.

Device: Neuromuscular electrical stimulation combined with conventional swallowing training

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

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, Neuromuscular electrical stimulation (NMES) and conventional swallowing therapy to those of sham rTMS, Neuromuscular electrical stimulation(NMES) and conventional swallowing therapy. One group will receive Neuromuscular electrical stimulation(NMES), to sham One group will receive Neuromuscular electrical stimulation(NMES),traditional swallowing therapy and rTMS therapy five times per week for 2 weeks ; Another group will receive Neuromuscular electrical stimulation(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.

Group A
Neuromuscular electrical stimulation combined with conventional swallowing trainingDEVICE

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, Neuromuscular electrical stimulation (NMES) and conventional swallowing therapy to those of sham rTMS, Neuromuscular electrical stimulation(NMES) and conventional swallowing therapy. One group will receive Neuromuscular electrical stimulation(NMES), to sham One group will receive Neuromuscular electrical stimulation(NMES),traditional swallowing therapy and rTMS therapy five times per week for 2 weeks ; Another group will receive Neuromuscular electrical stimulation(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.

Group AGroup B

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stroke
  • Onset time at least for one week，area not be limited.
  • Patient was first time stroke patient without obvious infection condition.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

StrokeDeglutition Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Chien-Hung Lai, MD, PhD

    Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Hung Lai, MD, PhD

CONTACT

02-27372181chlai@tmu.edu.tw

Chieh Chen, MD

CONTACT

+886933235048garyrbc@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 19, 2023

First Posted

May 17, 2023

Study Start

November 23, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

May 17, 2023

Record last verified: 2023-05

Locations

TW(1)