McNeill Dysphagia Therapy Program Combined With Transcranial Magnetic Stimulation

NCT06184711 | Unknown

• 1 other identifier: AnkaraCHBilkentKNS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate the effectiveness of the McNeill Dysphagia Therapy (MDTP) programme combined with Transcranial Magnetic Stimulation (TMS) in individuals with post-stroke dysphagia.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (4)

• Penetration Aspiration Scale

  Penetration Aspiration Scale (PAS): An 8-point severity rating. Scale 1 = no substance enters the airways 8 = substance enters the airways, passes under the vocal cords without any effort to expel it.

  Change from baseline from 3 weeks

• Functional Oral Intake Scale

  FOIS is a scale ranging from 1 (nothing by mouth) to 7 (total oral diet with no restriction)

  Change from baseline from 3 weeks

• Dynamic Rating Scale of Swallowing Toxicity

  Dynamic Imaging Grading of Ingestion Toxicity (DIGEST): residue less than 10% of the bolus = 0 point, residue less than half of the bolus = 1 point, residue less than 90% of the bolus = 2 points, residue more than 90% of the bolus = 3 points, residue in all consistencies tested = 4 points.

  Change from baseline from 3 weeks

• Dysphagia Severity Scale

  Dysphagia Severity Scale (DSS); those ranked from "level 1" to "level 4'' are categorized into the "choking/aspiration group (severe group)". In DSS, those ranked from "level 5" to "level 7'' are categorized into the "without choking/aspiration group (mild group)".

  Change from baseline from 3 weeks

Secondary Outcomes (2)

• Mann Swallowing Ability Assessment Test

  Change from baseline from 3 weeks

• Visual Analogue Scale (VAS)

  Change from baseline from 3 weeks

Study Arms (3)

Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy Programme

EXPERIMENTAL

The McNeill Dysphagia Therapy programme (MDTP) combined with Transcranial Magnetic Stimulation (TMS) will be applied to the first experimental group.

Device: Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy Programme

Sham Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy programme

SHAM COMPARATOR

The McNeill Dysphagia Therapy programme (MDTP) combined with sham Transcranial Magnetic Stimulation (TMS) will be applied to the sham comparator group.

Device: Sham Transcranial Magnetic Stimulation +McNeill Dysphagia Therapy Programme

Transcranial Magnetic Stimülation

EXPERIMENTAL

Only Transcranial Magnetic Stimulation (TMS) will be applied to the second experimental group.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation+McNeill Dysphagia Therapy Programme DEVICE

The McNeill Dysphagia Therapy programme (MDTP) combined with Transcranial Magnetic Stimulation (TMS) will be applied to the first experimental group.

Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy Programme

Sham Transcranial Magnetic Stimulation +McNeill Dysphagia Therapy Programme DEVICE

The McNeill Dysphagia Therapy programme (MDTP) combined with sham Transcranial Magnetic Stimulation (TMS) will be applied to the sham comparator group.

Sham Transcranial Magnetic Stimulation combined with the McNeill Dysphagia Therapy programme

Transcranial Magnetic Stimulation DEVICE

Only Transcranial Magnetic Stimulation (TMS) will be applied to the second experimental group.

Transcranial Magnetic Stimülation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dysphagia Diagnosis of ischaemic stroke Over 18 years old Cognitively competent and co-operative

You may not qualify if:

• Epilepsy or seizure risk record Carry metallic objects in the head (such as arterial clips, plates, screws), eye or brain

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Kübra Nur ŞİMŞEK

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kübra Nur ŞİMŞEK

CONTACT

+905543454446; kbranrsimsek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Speech and Language Therapist

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 28, 2023
• Study Start: December 29, 2023
• Primary Completion: December 29, 2025
• Study Completion: December 30, 2025
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

TU (1)