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

Neurophet

Status: Enrolling

Conditions: Deglutition Disorders

Treatments: Device: Sham transcranial Direct Current Stimulation; Device: Optimized transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06305949

XC23DDDS0098

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Optimized transcranial Direct Current Stimulation

Experimental group

Description:

Patients receive optimized stimulation obtained from an individualized T1 MRI-based simulation of transcranial direct current stimulation for 30 minutes, once a day for 4 weeks, for a total of 20 sessions.

Treatment:

Device: Optimized transcranial Direct Current Stimulation

Sham transcranial Direct Current Stimulation

Sham Comparator group

Description:

Patients receive sham stimulation for 30 minutes, once a day for 4 weeks, for a total of 20 sessions.

Treatment:

Device: Sham transcranial Direct Current Stimulation