Improving swallowing function in post-stroke patients using brain stimulation
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
NA · NEUROPHET · NCT06305949
This study tests if a special type of brain stimulation can help people who have trouble swallowing after a stroke improve their swallowing ability.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | NEUROPHET (industry) |
| Locations | 1 site (Bucheon-si) |
| Trial ID | NCT06305949 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of optimized transcranial direct current stimulation (tDCS) compared to sham stimulation in enhancing swallowing function in patients suffering from dysphagia following a stroke. Participants will include first-time stroke patients who are in the subacute or chronic phase of recovery, with confirmed swallowing difficulties. The study aims to determine if this non-invasive brain stimulation technique can provide temporary improvements in swallowing ability. The trial will involve a controlled setup where one group receives the active treatment while another group receives a placebo.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years old who have experienced a first-time stroke and have confirmed dysphagia.
Not a fit: Patients with recurrent strokes, traumatic brain injuries, or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with post-stroke dysphagia by enhancing their swallowing function.
How similar studies have performed: While the use of transcranial direct current stimulation is a relatively novel approach for this condition, similar studies have shown promising results in other neurological rehabilitation contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bucheon-si
- The Catholic University of Korea, Bucheon St. Mary's Hospital — Bucheon-si, South Korea (RECRUITING)
Study contacts
- Study coordinator: TaeYeong Kim
- Email: ty.kim@neurophet.com
- Phone: 827051678882
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Deglutition Disorders