Frequency Specific Microcurrent Therapy for Mild Traumatic Brain Injury

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dizziness; Brain Concussion; Headaches Posttraumatic; Trauma, Head; Frequency Specific Microcurrent Therapy
• Intervention / Treatment: Device: Frequency specific microcurrent therapy; Device: Sham Frequency specific microcurrent therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: I HAN Hsiao; Phone Number: +886933668642; Email: coolfishing2002@gmail.com
• Study Contact Backup: Name: CHEPIN CHANG; Phone Number: +886934073950; Email: freedyrae@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 20 and 65, inclusive, for both males and females.
2. History of traumatic brain injury with a loss of consciousness lasting less than 30 minutes, initial Glasgow Coma Scale (GCS) score ranging from 13 to 15.
3. Presence of persistent post-concussion symptoms starting from the day of injury and lasting for more than ten days.
4. Complete consciousness or decision-making capacity at the time of enrollment.
5. Brain imaging through CT or MRI indicating the absence of significant midline shift, no evident damage to the brainstem (excluding the pyramidal tract), or thalamus. Each brain lobe lesion should not exceed 30% of the respective cerebral hemisphere.

Exclusion Criteria:

1. Individuals below 20 years or above 65 years of age, regardless of gender.
2. History of traumatic brain injury with a loss of consciousness exceeding 30 minutes, initial Glasgow Coma Scale (GCS) score less than 13.
3. Not a first-time occurrence of traumatic brain injury.
4. Brain imaging through CT or MRI revealing significant midline shift, evident damage to the brainstem or thalamus, with each brain lobe lesion exceeding 30% of the respective cerebral hemisphere.
5. Presence of comorbidities such as cancer, depression.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; True FSM (Concussion protocol) with symptom management medication	Device: Frequency specific microcurrent therapy; Concussion protocol
Sham Comparator: Sham-control; Sham FSM (no protocol) with symptom management medication	Device: Sham Frequency specific microcurrent therapy; Shan concussion protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1.5 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the amount of medication used for symptom management	the amount of medication used for symptom management	1.5 month

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: I HAN Hsiao, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Estimated): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Concussion; Traumatic brain injury; Frequency specific microcurrent therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Sensation Disorders; Headache Disorders; Head Injuries, Closed; Wounds, Nonpenetrating; Headache Disorders, Secondary; Brain Injuries; Brain Injuries, Traumatic; Dizziness; Headache; Craniocerebral Trauma; Brain Concussion; Post-Traumatic Headache
• Other Study ID Numbers: CMUH112-REC3-176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No