Effect of Transcranial Direct Current Stimulation Combined With Oral Feeding on Dysphagia: A Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Zeng Changhao
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Penetration Aspiration Scale
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University
Eligibility Criteria
Inclusion Criteria
- •Meet the diagnostic criteria for ischemic stroke;
- •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.
Outcomes
Primary Outcomes
Penetration Aspiration Scale
Time Frame: day 1 and day 15
Penetration-Aspiration Scale is used to measure swallowing safety, which is also the primary outcome of this study. Before and after treatment, patients are required to undergo a swallow study to complete the assessment. This scale evaluates the patient's swallowing function level and aspiration risk by assessing leakage and aspiration during the patient's swallowing process. The results are divided into eight levels, with higher levels indicating poorer swallowing function and lower swallowing safety.
Secondary Outcomes
- Swallowing Quality of Life Questionnaire(day 1 and day 15)
- Functional Oral Intake Scale(day 1 and day 15)
- Nutritional status-total protein(day 1 and day 15)
- Nutritional status-albumin(day 1 and day 15)
- Patient Health Questionnaire-9(day 1 and day 15)
- Body weight(day 1 and day 15)