Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Musculoskeletal Pain in Cerebral Palsy

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with cerebral palsy who have had long-lasting muscle and joint pain. It tests a gentle ear nerve stimulation device used at home for 30 days.

Életkor

18 years or older

Nem

All sexes

A betegség stádiuma

Cerebral palsy with chronic musculoskeletal pain for at least 1 year. Pain must be moderate or worse, at least 4/10 on a pain scale.

Korábbi kezelés

Doses of pain and/or anti-inflammatory medicines must have stayed the same for at least 6 weeks.

A részvétel fő kizáró okai

• Heart or blood vessel disease
• Pacemaker or other implanted electrical device
• Shunt in the brain (cerebral shunt)
• Pregnancy or plans to become pregnant
• Current infection or open wounds where the electrodes go

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

This randomized, double-blind, sham-controlled clinical trial will evaluate the safety and efficacy of a 30-day home-based transcutaneous auricular vagus nerve stimulation (taVNS) intervention in adults with cerebral palsy (CP) and chronic musculoskeletal pain. Participants will be randomized to receive either active taVNS targeting the auricular branch of the vagus nerve or sham stimulation delivered to the earlobe. The primary outcomes are changes in musculoskeletal pain severity and pain interference, as well as safety assessed through treatment-emergent adverse events. Exploratory outcomes include health-related quality of life, depression, fatigue, spasticity, systemic inflammatory biomarkers, and blinding success.

A vizsgálat 2 csoportja

• Active taVNSA vizsgált kezelés

  Participants receive active transcutaneous auricular vagus nerve stimulation delivered via the cymba conchae of the left ear using the using the tVNS R device (taVNS Technologies, Erlangen, Germany) for 4 hours per day for 30 days.

  Kezelés: Active Transcutaneous Auricular Vagus Nerve Stimulation

• Sham taVNSSzínlelt kezelés, összehasonlításként

  Stimulation will target the ear lobe using the tVNS R device (taVNS Technologies, Erlangen, Germany) for 4 hours per day for 30 days. Stimulation will be applied to the ear lobe in order to ensure participant feel the stimulation while avoiding activation of the vagus nerve.

  Kezelés: Sham Transcutaneous Auricular Vagus Nerve Stimulation