Frequency Specific Microcurrent Therapy for Mild Traumatic Brain Injury

Brain Concussion Clinical Trial

Official title: Frequency Specific Microcurrent Therapy for Mild Traumatic Brain injury-a Single Center Double-blind Randomized Sham-controlled Trail

Status Not yet recruiting

Clinical Trial Summary

Patients with mild traumatic brain injury (mTBI) may experience spontaneous recovery within 7-10 days, but some continue to exhibit symptoms such as headache, dizziness, vertigo, poor concentration, and cognitive dysfunction. Effective treatments for these symptoms are currently lacking. Frequency Specific Microcurrent(FSM) has received approval from the U.S. FDA for use in neuroinflammatory conditions. Our study aims to evaluate the efficacy of FSM by using FSM device ,IS02LCDs Stimulator (Ru Yi Health ltd. Co,Taiwan R.O.C), on symptom improvement in 52 patients with mild TBI

Clinical Trial Description

This study is a single center double-blind randomized sham-controlled trail.We aims to recruit 52 mild traumatic brain injury participants with symptoms for more than 10 days.Clinical assessments include Post-Concussion Symptom Scale (PCSS) scores, and the amount of medication used for symptom management. These 52 participants will be 1:1 randomly allocated into two groups (1) sham FSM with symptom management medication and (2) True FSM with symptom management medication. The treatment period will last two weeks, with a total of six therapy sessions. Following treatment, a four-week observation period will be conducted. The primary outcome measurement will be changes in the Post-Concussion Symptom Scale (PCSS) scores, recorded at baseline, after the third treatment session, at the end of treatment, and at the end of the observation period. Secondary outcome measures will include the amount of medication used for symptom management. The safety evaluated index is the adverse event rate for two groups. These assessments aim to evaluate the therapeutic benefits of FSM for mild traumatic brain injury. ;

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Craniocerebral Trauma
• Dizziness
• Headache
• Headaches Posttraumatic
• Post-Traumatic Headache
• Trauma, Head

• NCT number: NCT06245967
• Study type: Interventional
• Source: China Medical University Hospital
• Contact: I HAN Hsiao
• Phone: +886933668642
• Email: coolfishing2002@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Completion date: February 28, 2026