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

Zhang Xiaohui

Status: Invitation-only

Conditions: Dysphagia; Stroke; Transcranial Magnetic Stimulation; Functional Near- Infrared Spectroscopy

Treatments: Device: Theta burst transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06471309

20240619

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Bilateral stimulation group

Experimental group

Description:

On the basis of routine treatment and routine swallowing rehabilitation training, 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

Treatment:

Device: Theta burst transcranial magnetic stimulation

Unilateral stimulation group

Experimental group

Description:

On the basis of routine treatment and routine swallowing rehabilitation training, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side

Treatment:

Device: Theta burst transcranial magnetic stimulation

Sham stimulation group

Sham Comparator group

Description:

On the basis of routine treatment and routine swallowing rehabilitation training, sham iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side

Treatment:

Device: Theta burst transcranial magnetic stimulation