Treatment for swallowing difficulties after stroke using stimulation techniques
Treatment of Chronic Post-stroke Oropharyngeal Dysphagia With Paired Stimulation Through Peripheral TRVP1 Agonists and Non-invasive Brain Stimulation
This study is testing two new ways to help people who have trouble swallowing after a stroke by using special brain and nerve stimulation techniques combined with a medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital de Mataró Academic / other |
| Locations | 1 site (Mataró, Barcelona) |
| Trial ID | NCT05720871 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a novel approach to treating chronic oropharyngeal dysphagia in post-stroke patients by combining peripheral pharmacological stimulation with central non-invasive brain stimulation techniques. The study will assess the effectiveness of two different stimulation strategies—repetitive transcranial magnetic stimulation (rTMS) paired with capsaicin and transcranial direct current stimulation (tDCS) paired with capsaicin—over a five-day period. The primary outcome will focus on improvements in swallowing safety as measured by videofluoroscopy, while secondary outcomes will evaluate safety, adverse events, and overall clinical improvements at three months follow-up.
Who should consider this trial
Good fit: Ideal candidates include adults with chronic unilateral hemispheric stroke who have impaired swallowing safety as indicated by a penetration-aspiration score of 2 or higher.
Not a fit: Patients with dysphagia not related to stroke, neurodegenerative disorders, or those with implanted electronic devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve swallowing function and quality of life for patients suffering from chronic post-stroke oropharyngeal dysphagia.
How similar studies have performed: While the combination of these specific stimulation techniques is novel, similar approaches in neurorehabilitation have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic (\>3 and \<24 months) unilateral hemispheric stroke adult patients. * Patients with impaired safety of swallow with a penetration-aspiration score (PAS) ≥ 2 with videofluoroscopy (VFS). * Patient able to follow the study protocol and give the written informed consent. Exclusion Criteria: * Pregnancy. * Life expectancy less than 3m or palliative care. * Neurodegenerative disorder. * Previously diagnosed oropharyngeal dysphagia (dysphagia not related to stroke). * Implanted electronic device. * Epilepsy. * Metal in the head. * Participation in another clinical trial in the previous month.
Where this trial is running
Mataró, Barcelona
- Hospital de Mataró. Consorci Sanitari del Mareme. — Mataró, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Pere Clavé, MD, PhD — Consorci Sanitari del Maresme
- Study coordinator: Pere Clavé, MD, PhD
- Email: pclave@csdm.cat
- Phone: +34937417700
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.