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Enrolling by invitation NCT06471309

Effect of Theta Burst Transcranial Magnetic Stimulation on Patients with Dysphagia After Stroke

No phase Interventional Stroke Dysphagia Functional Near- Infrared Spectroscopy Transcranial Magnetic Stimulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Theta burst transcranial magnetic stimulation.
Who it may be relevant to
Registry conditions: Stroke, Dysphagia, Functional Near- Infrared Spectroscopy, Transcranial Magnetic Stimulation. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
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Official title

Effect of Theta Burst Transcranial Magnetic Stimulation on Post-Stroke Dysphagia

Overview

The purpose of this study was to observe the effect of Theta burst transcranial magnetic stimulation (TBS) on swallowing function in patients with dysphagia after stroke (PSD). Functional near- infrared spectroscopy (fNIRS) was used to detect the changes in activation and functional connectivity of related brain regions in PSD patients treated with intermittent TBS（iTBS）stimulation on the affected side and consistent TBS（cTBS） stimulation on the healthy side. To investigate the effects of TBS on swallowing related cortical excitability in stroke patients with dysphagia and explore its possible mechanism, and provide theoretical basis for the treatment of PSD patients.

Interventions

  • Device Theta burst transcranial magnetic stimulation
    The stimulation intensity of TBS was 80%RMT, with a total of 600 pulses, five times a week for two weeks. In the bilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. In the unilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to t

Primary outcome measures

  • Rosenbek Penetration-aspiration scale [Time frame: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.]
  • Standardized Swallowing Assessment [Time frame: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.]
  • functional near- infrared spectroscopy [Time frame: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.]

Eligibility criteria

Inclusion criteria

  • Age 18-80 years old
  • The first stroke lasted from 2 weeks to 6 months, with stable vital signs and right-handedness
  • The stroke met the diagnostic criteria of "Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage 2019" or "Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018" formulated by the Cerebrovascular Department of the Branch of Neurology of the Chinese Medical Association, and the cerebral CT or MRI examination showed unilateral cerebral infarction or cerebral hemorrhage.
  • The dysphagia was consistent with the Expert Consensus on the Evaluation and Treatment of dysphagia in China (2017 edition), and the dysphagia was confirmed by videofluoroscopic swallowing study.
  • MMSE>24, good cognitive function
  • The skull is intact without craniotomy or repair
  • Subject or family members sign informed consent

Exclusion criteria

  • Combined with other diseases that may cause swallowing disorders, such as Parkinson's disease, dementia, motor neurone disease and other neurological diseases, or esophageal, neck surgery and other diseases that cause swallowing organ structure abnormalities
  • A history of mental illness or epilepsy
  • A metal implant in the head or eye, a pacemaker or a drug pump in the body
  • Pregnancy, malignant tumor, serious disease history of heart, liver, kidney and other important organs
  • Ulceration or infection of the skin on the head or where the electrode is applied
  • Poor compliance and inability to complete basic treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou

Identifiers

NCT: NCT06471309 · 20240619

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗