Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Tube on Dysphagia

Last updated: March 2, 2024
Sponsor: Zeng Changhao
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Occlusions

Cerebral Ischemia

Treatment

Transcranial direct current stimulation

Comprehensive rehabilitation therapy

Intermittent Oro-esophageal Tube Feeding

Clinical Study ID

NCT06265779
2024-KY-0122
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 endoscopicevaluation of swallowing;
  • Requires enteral nutrition support;
  • Stable vital signs, no severe cognitive impairment or aphasia, able to cooperate withtreatment;
  • Transferred to the rehabilitation department within fifteen days of onset;
  • Stable vital signs.

Exclusion

Exclusion Criteria:

  • Presence of contraindications for invasive oral endoscopy;
  • Concurrent presence of other neurodegenerative diseases that may cause swallowingdisorders, 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 asepilepsy, cerebral edema;
  • Recent use of centrally acting drugs that interfere with the effects of transcranialdirect current stimulation, such as carbamazepine, phenytoin, valproic acid, etc.

Study Design

Total Participants: 84
Treatment Group(s): 3
Primary Treatment: Transcranial direct current stimulation
Phase:
Study Start date:
February 29, 2024
Estimated Completion Date:
December 15, 2024

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Zheng Da Second Yuan Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Guanghan People's Hospital

    Guanghan, Sichuan 618300
    China

    Site Not Available

  • Mianyang Central Hospital

    Mianyang, Sichuan 621000
    China

    Site Not Available

  • Center Rehabilitation Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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