Safety and Efficacy of Carpal Stim in Treating Carpal Tunnel Syndrome

Inclusion criteria

• Male or female subjects aged ≥ 20 years old during the recruitment phase
• Clinical diagnosis of CTS：

• Diagnosis of CTS was confirmed by Nerve Conduction Velocity (NCV) but not limited to NCV
• Symptoms consistent with CTS for at least 3 months and the numerical rating scale (NRS) score ≥ 5 during the recruitment phase
• Willing to abstain from any other treatment or therapy for CTS throughout the trial except protocol-described medications
• The subject is willing and able to comply with the procedure and requirements of this trial
• The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements

Exclusion criteria

• Wrist fractures or cysts at the CTS affected side
• Wrist surgery within the past 3 months, especially carpal tunnel release surgery at the CTS affected side
• Receiving upper limb (including neck) surgery
• Injections of corticosteroids/cortisone into the wrist or hand within the past 3 months
• With a past medical history of diabetic polyneuropathy
• With a past medical history of rheumatoid arthritis
• With a past medical history of epilepsy
• Body Mass Index (BMI) > 40 kg/m2
• Participation in any investigational study in the last 2 weeks or current enrollment in any trial.
• Active infection at the stimulator contact site during the recruitment phase
• Pregnant women or diagnosed with postpartum edema in the wrist per investigator's discretion
• Patients with implanted medical devices that are electronic products, such as implantable cardioverter defibrillators, pacemakers, spinal cord stimulation systems, or spinal cord drug infusion pumps