Effects of Repetitive Transcranial Magnetic Stimulation on Patients With Dysphagia in Stroke Observed Based on Functional Near-infrared Spectroscopic

NCT06213597 | Completed

• 1 other identifier: 2020-PT310-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This trial was a randomized, double-blind, sham-controlled trial.Thirty patients with post-stroke dysphagia were randomly assigned to the repetitive transcranial magnetic stimulation(rTMS) group (n=15) or sham rTMS group (n=15). Both groups received conventional swallowing rehabilitation, and in addition, the rTMS group received 5hz repetitive transcranial magnetic stimulation on the healthy side. Swallowing function was assessed at admission and after two weeks of treatment using the the Standardized Swallowing Assessment (SSA), the Penetration-Aspiration Scale (PAS), the Fiberoptic Endoscopic Dysphagia Severity Scale(FEDSS), the Functional Oral Intake Scale (FOIS), and the functional near-infrared spectroscopic(fNIRS).

Conditions

Stroke; Deglutition Disorders

Outcome Measures

Primary Outcomes (1)

• Standardized Swallowing Assessment

  SSA: consists of 3 parts, scoring 18-46 points: clinical evaluation, including consciousness, lip control and other seven items, total score 8-23 points; take about 5ml of water for the patient to swallow, repeat 3 times, the corner of the mouth with or without water, swallowing with or without laryngeal movement to observe the situation, the total score of 5-11 points; the first two items are normal, the amount of water was increased to about 60 ml, and whether the drink can be completed the whole situation, the total score of 5-12 points. The total score is 5\~12. The higher the score, the more serious the swallowing disorder.

  day 1 and day 14

Secondary Outcomes (4)

• Penetration-Aspiration Scale

  day 1 and day 14

• Fiberoptic Endoscopic Dysphagia Severity Scale

  day 1 and day 14

• Functional Oral Intake Scale

  day 1 and day 14

• Functional near-infrared spectroscopy

  day 1 and day 14

Study Arms (2)

repetitive transcranial magnetic stimulation group

EXPERIMENTAL

Randomization was performed by a staff member of our hospital, who was not involved in the implementation or evaluation of the trial, and who randomly assigned subjects to either the rTMS group or the sham rTMS group in a 1:1 ratio through the use of an electronic random sequence generator. Opaque, sealed envelopes were used to mask the randomization tables.

Other: routine swallowing rehabilitation; Device: real repetitive transcranial magnetic stimulation

sham repetitive transcranial magnetic stimulation

SHAM COMPARATOR

Randomization was performed by a staff member of our hospital, who was not involved in the implementation or evaluation of the trial, and who randomly assigned subjects to either the rTMS group or the sham rTMS group in a 1:1 ratio through the use of an electronic random sequence generator. Opaque, sealed envelopes were used to mask the randomization tables.

Other: routine swallowing rehabilitation; Device: sham repetitive transcranial magnetic stimulation

Interventions

routine swallowing rehabilitation OTHER

Routine swallowing rehabilitation training mainly included oral and facial muscle training, ice stimulation therapy, Mendelssohn maneuver training, and tongue root resistance training. The subjects were treated twice a day, Monday through Saturday, for 20 min each time for 2 weeks. All operations were performed by the same trained and qualified professional rehabilitation therapist.

repetitive transcranial magnetic stimulation group; sham repetitive transcranial magnetic stimulation

real repetitive transcranial magnetic stimulation DEVICE

In the rTMS group, 5 Hz rTMS was applied to the hot spot of the supraglottic motor cortex of the affected hemisphere at a treatment intensity of 80% resting motor threshold for 10 min, with a total of 250 pulses (with an interval of 11 s for every 1 s of continuous stimulation), and the treatment was performed once a day for 6 d per week for 2 weeks.

repetitive transcranial magnetic stimulation group

sham repetitive transcranial magnetic stimulation DEVICE

The sham rTMS group supplemented pseudomagnetic stimulation at the hotspot of the representative area, tilted the magnetic stimulation coil at 90°, and the same noise was emitted by the instrument during the treatment, but no stimulation was performed, and the group was treated once a day, 6d per week, for 2 weeks.

sham repetitive transcranial magnetic stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age, right-handed;
• unilateral stroke, diagnosed by cranial MRI or CT;
• disease duration of 2 weeks to 6 months;
• dysphagia confirmed by the Videofluoroscopic swallowing study;
• patient's vital signs were stable;
• consciousness was clear, able to cooperate in completing the rehabilitation therapy, assessment, and the fNIRS test;
• cranial bone was intact without craniotomy and/or craniovertebral repair;
• the subject signed the Declaration of Helsinki according to the Informed consent.

You may not qualify if:

• previous dysphagia due to other diseases such as Parkinson's disease, dementia, or the presence of organic swallowing dysfunction;
• contraindications to rTMS: stimulation coils or the presence of a metal foreign body near the stimulated scalp, built-in pulse generators, cardiac stents, cardiac bypass grafting, etc;
• previous history of psychiatric disease or epilepsy;
• pregnancy;
• skin infection or breakage on the head;
• previous or current stroke, traumatic brain injury and other neurological or mental system diseases;
• serious cardiac, pulmonary, hepatic, renal dysfunction, malignant tumors, serious complications;
• poor patient compliance and evaluation,other neurological or psychiatric disorders;
• severe cardiac, pulmonary, hepatic, or renal dysfunction, malignant tumors, and serious complications;
• poor patient compliance and non-cooperation with treatment and evaluation.

Sponsors & Collaborators

• Ruyao Liu: lead

Study Sites (1)

The first affiliated hospital of zhengzhou university

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Xi Zeng

  The First Affiliated Hospital of Zhengzhou University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: May 28, 2023
• Primary Completion: December 25, 2023
• Study Completion: January 8, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)