An interventional study of Frequency specific microcurrent therapy and Sham Frequency specific microcurrent therapy in Trauma, Head, Headaches Posttraumatic and Dizziness, sponsored by China Medical University Hospital. Not yet recruiting. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment
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
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.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 52 is below the median of 63 across 446 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →China Medical University Hospital is the lead sponsor of 479 studies on the registry; 115 are open to participants now.
Compared within Brain Concussion, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Craniocerebral Trauma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
True FSM (Concussion protocol) with symptom management medication
Device: Frequency specific microcurrent therapy
Sham FSM (no protocol) with symptom management medication
Device: Sham Frequency specific microcurrent therapy
Concussion protocol
Shan concussion protocol
Post-Concussion Symptom Scale (PCSS) scores
The Post-Concussion Symptom Scale (PCSS) is used to assess the number and intensity of symptoms after a concussion/mild traumatic brain injury.
Time frame: 1.5 month
the amount of medication used for symptom management
the amount of medication used for symptom management
Time frame: 1.5 month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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China Medical University Hospital →