Trial · NCT07894315
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
NCT07894315, Not applicable, Not yet recruiting, First Affiliated Hospital of Fujian Medical University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia. Trials, record NCT07894315. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07894315
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
- NCT number
- NCT07894315
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 60 participants, estimated
- Lead sponsor
- First Affiliated Hospital of Fujian Medical University
- Conditions
- Ischemic Stroke, Post-stroke Dysphagia, Swallowing Disorders
- Interventions
- EEG Biofeedback-Guided taVNS, Conventional taVNS
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Functional Oral Intake Scale (FOIS) Score | Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up) | The Functional Oral Intake Scale (FOIS) is a clinician-rated assessment tool used to evaluate the functional level of oral intake of food and liquid in dysphagia patients. It assesses the patient's actual dietary intake and dependence on tube feeding. Unit of Measure: Units on a Scale. Score range: 1 to 7. A score of 1 indicates nothing by mouth (NPO), and a score of 7 indicates total oral diet with no restrictions. Therefore, higher scores indicate better functional oral intake and improved swallowing ability. |
| Secondary | Penetration-Aspiration Scale (PAS) Score | Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up) | The Penetration-Aspiration Scale (PAS) is a standardized scoring system used during Video fluoroscopic Swallowing Study (VFSS) to objectively assess airway protection. It evaluates the depth to which material passes into the airway and whether the patient is able to expel it. Unit of Measure: Units on a Scale. Score range: 1 to 8. A score of 1 indicates material does not enter the airway, and a score of 8 indicates material enters the airway, passes below the vocal folds, and no effort is made to eject it. Therefore, higher scores indicate worse swallowing safety and a greater severity of aspiration. |
| Secondary | Functional Dysphagia Scale (FDS) Score | Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up) | The Functional Dysphagia Scale (FDS) is a semi-quantitative assessment tool based on Video fluoroscopic Swallowing Study (VFSS) findings. It is used to quantify the severity of swallowing dysfunction by evaluating both the oral phase and the pharyngeal phase. Unit of Measure: Units on a Scale. Score range: 0 to 100. A score of 0 indicates normal swallowing function, and a score of 100 indicates the most severe swallowing impairment. Therefore, higher scores indicate worse swallowing function. |
| Secondary | Swallowing Quality of Life (SWAL-QOL) Questionnaire Score | Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up) | The Swallowing Quality of Life (SWAL-QOL) questionnaire is a patient-reported outcome measure used to comprehensively assess the multi-dimensional impact of dysphagia on physical, social, and psychological well-being. Unit of Measure: Units on a Scale. Score range: 0 to 100 for the total score. A score of 0 represents the worst possible quality of life, and a score of 100 represents the best possible quality of life. Therefore, higher scores indicate a better quality of life. |
| Secondary | Mini Nutritional Assessment (MNA) Score | Baseline (Pre-treatment), Week 2 (Post-treatment), Week 4 (Follow-up) | The Mini Nutritional Assessment (MNA) is a validated screening and assessment tool used to evaluate the nutritional status and identify the risk of malnutrition in elderly and post-stroke patients. Unit of Measure: Units on a Scale. Score range: 0 to 30. A score of 24-30 indicates normal nutritional status, and a score of less than 17 indicates malnutrition. Therefore, higher scores indicate better nutritional status. |
| Secondary | Changes in Cerebral Cortex Hemodynamic Responses using Functional Near-Infrared Spectroscopy (fNIRS) | Baseline (Pre-treatment), Week 2 (Post-treatment) | Functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging technique used to continuously monitor changes in the concentration of oxygenated hemoglobin (HbO2) in the sensorimotor and swallowing-related cortical areas during swallowing tasks. This assesses task-related cortical activation and functional cortical reorganization. Unit of Measure: Micro Molar (μmol/L). Higher HbO2 concentration changes indicate greater cortical activation and enhanced neural plasticity in swallowing networks. |
| Secondary | Changes in Cortical Oscillations and Brain Network Connectivity using High-Density Electroencephalogram (EEG) | Baseline (Pre-treatment), Week 2 (Post-treatment) | High-density electroencephalogram (EEG) is a neurophysiological measurement used to evaluate the absolute and relative power spectral density across different frequency bands (Delta, Theta, Alpha, Beta, and Gamma) and calculates functional connectivity metrics between key swallowing-related brain networks during resting state. Unit of Measure: Coherence value (Units on a Scale). Higher functional connectivity coefficients (coherence values) indicate stronger inter-regional brain coupling and improved neural network synchronization. |
| Secondary | Changes in Whole-Brain Resting-State Functional Connectivity using Resting-State Functional Magnetic Resonance Imaging (rs-fMRI) | Baseline (Pre-treatment), Week 2 (Post-treatment) | Resting-state functional magnetic resonance imaging (rs-fMRI) is an advanced neuroimaging modality used to detect spontaneous low-frequency fluctuations. It calculates the amplitude of low-frequency fluctuations (ALFF) and seed-based functional connectivity specifically between swallowing network nodes and brainstem/cortex regions. Unit of Measure: Z-score. Higher Z-scores indicate enhanced baseline neural activity, stronger functional connectivity, and significant neural network remodeling. |
| Secondary | Changes in Corticospinal Excitability using Transcranial Magnetic Stimulation Motor Evoked Potentials (TMS-MEP) | Baseline (Week 0) and 2 weeks post-treatment (Week 2) | Transcranial magnetic stimulation (TMS) is used to elicit motor evoked potentials (MEP) recorded from swallowing-related musculature (e.g., mylohyoid muscle). This technique evaluates the functional integrity and excitability of the corticobulbar and corticospinal motor pathways targeting the swallowing muscles. Unit of Measure: Millivolts (mV). A higher peak-to-peak MEP amplitude indicates increased excitability of the motor pathways and positive neural remodeling in the central nervous system. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07894315
GET https://conductscience.org/api/trials/v1/NCT07894315/registered