Combining Transcranial Direct Current Stimulation With Intermittent Oral to Esophageal Tube for Stroke-related Dysphagia

Copka Sonpashan

Status: Not yet enrolling

Conditions: Stroke

Treatments: Device: Transcranial direct current stimulation; Behavioral: Placebo Transcranial direct current stimulation; Behavioral: Comprehensive rehabilitation therapy; Device: Intermittent Oro-esophageal Tube Feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT06329011

TDC+IOE

Details and patient eligibility

About

The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.

Full description

Transcranial direct current stimulation is currently very popular. The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet the diagnostic criteria for ischemic stroke confirmed by MRI or CT;
• Age > 18 years;
• First-time stroke;
• Swallowing disorder confirmed by swallowing contrast study or flexible endoscopic evaluation of swallowing;
• Requires enteral nutrition support;
• Stable vital signs, no severe cognitive impairment or aphasia, able to cooperate with treatment;
• Transferred to the rehabilitation department within fifteen days of onset;
• Stable vital signs.

Exclusion criteria

• Presence of contraindications for invasive oral endoscopy;
• Concurrent presence of other neurodegenerative diseases that may cause swallowing disorders, such as neurodegenerative diseases;
• Concurrent presence of other neurological disorders;
• Tracheostomized patients;
• Concurrent liver, kidney failure, tumor, or hematological disorders;
• Pregnancy;
• Presence of contraindications for transcranial direct current stimulation, such as epilepsy, cerebral edema;
• Recent use of centrally acting drugs that interfere with the effects of transcranial direct current stimulation, such as carbamazepine, phenytoin, valproic acid, etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Comprehensive rehabilitation+Intermittent Oro-esophageal Tube+Transcranial stimulation

Experimental group

Description:

The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.

Treatment:

Behavioral: Comprehensive rehabilitation therapy

Device: Transcranial direct current stimulation

Device: Intermittent Oro-esophageal Tube Feeding

Comprehensive rehabilitation+Intermittent Oro-esophageal Tube

Placebo Comparator group

Description:

The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.

Treatment:

Behavioral: Placebo Transcranial direct current stimulation

Behavioral: Comprehensive rehabilitation therapy

Device: Intermittent Oro-esophageal Tube Feeding