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Search / Trial NCT06329011

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

Launched by COPKA SONPASHAN · Mar 18, 2024

Trial Information

Current as of August 20, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients who have difficulty swallowing (dysphagia) after having a stroke. Specifically, the study aims to see if adding a type of brain stimulation called transcranial direct current stimulation (tDCS) helps improve swallowing abilities when combined with regular rehabilitation therapies and a feeding tube. Participants will be randomly assigned to either the group receiving the active treatment or a placebo group, which means they may not know if they are getting the real treatment or a dummy version that doesn’t have any effect.

To participate in this trial, individuals must be over 18 years old, have had their first stroke confirmed by brain scans, and have a swallowing disorder that requires nutritional support through a feeding tube. They should also be able to cooperate with the treatment and have stable vital signs. The trial lasts for 15 days, during which all participants will receive standard rehabilitation and swallowing training. It’s important to note that certain health conditions or medications may exclude someone from participating. Overall, this study aims to explore new ways to help stroke survivors regain their ability to swallow safely and effectively.

Gender

ALL

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.

About Copka Sonpashan

Copka Sonpashan is a leading clinical trial sponsor dedicated to advancing innovative therapeutic solutions through rigorous research and development. With a focus on enhancing patient care, the organization specializes in designing and executing clinical trials across various therapeutic areas, ensuring compliance with regulatory standards and ethical guidelines. By fostering collaboration with healthcare professionals and leveraging cutting-edge technologies, Copka Sonpashan aims to expedite the drug development process while maintaining a steadfast commitment to patient safety and scientific integrity.

Locations

Patients applied

0 patients applied

Trial Officials

Nieto Luis

Study Chair

Site Coordinator of United Medical Group located in Miami

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported