Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia

Launched by NEUROPHET · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment to help improve swallowing difficulties (called dysphagia) in patients who have had a stroke. The treatment involves using a technique known as transcranial direct current stimulation, which gently sends a small electrical current to the brain. The goal is to see if this treatment is more effective than a placebo (a "dummy" treatment that doesn’t provide real stimulation) in helping patients swallow better.

To participate, you need to be over 19 years old and have experienced a first-time stroke, confirmed by brain imaging. You should also be in the subacute or chronic phase of recovery, meaning it’s been at least three weeks since your stroke, and have been diagnosed with swallowing difficulties through a specific swallowing test. If you meet these criteria, you may be eligible to join the study. Participants can expect to receive either the actual treatment or the placebo during the trial and will be monitored for any changes in their swallowing function. It's important to note that certain health conditions, medications, or previous treatments may disqualify some individuals from participating.

Gender

ALL

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.