Using brain stimulation and feeding tubes to help with swallowing after a stroke

Therapeutic Effect of Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Feeding on Swallowing Disorders in Patients With Cerebral Infarction: Double Blind Randomized Controlled Study

This study is testing if a special brain stimulation, along with feeding tubes, can help people who have trouble swallowing after a stroke recover better than with regular treatment alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: People's Hospital of Zhengzhou University (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT06265779 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of transcranial direct current stimulation combined with intermittent oral to esophageal tube feeding on patients suffering from dysphagia following a cerebral infarction. It is a double-blind randomized controlled trial lasting 15 days, where participants are assigned to either an experimental group receiving the stimulation or a placebo group. All participants will also undergo routine rehabilitation therapy and swallowing training, along with enteral nutrition support. The goal is to determine if the brain stimulation enhances swallowing recovery compared to standard care alone.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who have experienced their first ischemic stroke and have confirmed swallowing disorders requiring enteral nutrition.

Not a fit: Patients with other neurodegenerative diseases, severe cognitive impairments, or contraindications for the interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve swallowing function in patients recovering from strokes.

How similar studies have performed: While transcranial direct current stimulation has shown promise in other neurological conditions, this specific combination approach is relatively novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Seoul

• Center Rehabilitation Hospital — Seoul, Korea, Republic of (RECRUITING)

Study contacts

• Principal investigator: Nieto Luis, Master — Site Coordinator of United Medical Group located in Miami
• Study coordinator: Zhefeng Wang, Master

Conditions: Cerebral Infarction