Clinical trial NCT06305949: Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia
Official title: A Multi-center, Randomized, Double-blind, Pilot Study to Evaluate the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Transitory Improvement of Swallowing Function in Patients With Post-stroke Dysphagia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deglutition Disorders
Lead sponsor: NEUROPHET
Sponsor class: INDUSTRY
Collaborators: name: Bucheon St. Mary's Hospital
name: Saint Vincent's Hospital, Korea
name: National Traffic Injury Rehabilitation Hospital
name: Pusan National University Yangsan Hospital
First posted: 2024-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia.


Eligibility criteria: Inclusion Criteria:

* men and women \>19 years old
* patients with stroke confirmed by neuroimaging
* first-time stroke patients
* patients in subacute or chronic phases of stroke with 3 weeks or more after onset
* stroke patients with confirmed dysphagia through Videofluoroscopic Swallowing Study (VFSS).

Exclusion Criteria:

* patients with recurrent stoke, traumatic brain injury, spine cord injury, and degenerative brain disease, such as Parkinson's disease, etc.
* patients with deteriorated cognitive function unable to perform the clinical trial as instructed
* patients with evidence of delirium, confusion, or other impairment of consciousness
* patients with uncontrolled medical disease or surgical conditions
* patients ineligible for Transcranial direct current stimulation (due to scalp condition, metallic material at the electrode attachment area, presence of a pacemaker or cochlear implant)
* patients with previous experience within the last year using a stimulation device similar to the one use in this clinical trial or who have participated in related clinical trials
* patients with severe neurologic disorder with concomitant major psychiatric disorder such as major depressive disorder and dementia
* patients with history of uncontrolled epilepsy within 6 months
* patients with medical contraindications for neuroimaging test, such as MRI;
* patients who are taken contraindicated medications or require medication changes during the trial period that could influence cognitive/motor function changes via brain activation changes
* patients who are pregnant, breastfeeding, or planning pregnancy during the trial period
* patients considered medically ineligible for participation in the present trial beyond the criteria listened above.

Primary outcomes:
measure: Functional Oral Intake Scale (FOIS)
timeFrame: Baseline, At 4 weeks from baseline
measure: Penetration-aspiration Scale (PAS)
timeFrame: Baseline, At 4 weeks from baseline
Secondary outcomes:
measure: Functional Oral Intake Scale (FOIS)
timeFrame: Baseline, At 2, 4, and 8 weeks from baseline
measure: Penetration-aspiration Scale (PAS)
timeFrame: Baseline, At 2, 4, and 8 weeks from baseline
measure: Videofluoroscopic Dysphagia Scale (VDS)
timeFrame: Baseline, At 2, 4, and 8 weeks from baseline
measure: Korean Mann Assessment of Swallowing Ability (K-MASA)
timeFrame: Baseline, At 2, 4, and 8 weeks from baseline
measure: Speech Mechanism Screening Test (SMST)
timeFrame: Baseline, At 4, and 8 weeks from baseline
measure: Urimal Test of Articulation and Phonology (U-TAP)
timeFrame: Baseline, At 4, and 8 weeks from baseline
measure: modified Rankin Scale (mRS)
timeFrame: Baseline, At 2, 4, and 8 weeks from baseline
measure: Gugging Swallowing Screen
timeFrame: Baseline, At 2, 4, and 8 weeks from baseline
measure: Eating Assessment Tool-10 (EAT-10)
timeFrame: Baseline, At 2, 4, and 8 weeks from baseline
measure: Iowa Oral Performance Instrument (IOPI)
timeFrame: Baseline, At 4, and 8 weeks from baseline
measure: Motor-Evoked Potential (MEP)
timeFrame: Baseline, At 2 and 4 weeks from baseline
measure: Grade, Roughness, Breathiness, Asthenia and Strain scale(GRBAS scale)
timeFrame: Baseline, At 4, and 8 weeks from baseline
measure: Respiratory muscle strength
timeFrame: Baseline, At 4, and 8 weeks from baseline
measure: Peak cough flow
timeFrame: Baseline, At 4, and 8 weeks from baseline
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St. Mary's Hospital
Study officials:
References: