Frequency Specific Microcurrent Therapy for Mild Traumatic Brain Injury

NCT ID: NCT06245967

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2026-02-28

Brief 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

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.

Conditions

Trauma, Head; Headaches Posttraumatic; Dizziness; Brain Concussion; Frequency Specific Microcurrent Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental

True FSM (Concussion protocol) with symptom management medication

Group Type: EXPERIMENTAL

Frequency specific microcurrent therapy

Intervention Type: DEVICE

Concussion protocol

Sham-control

Sham FSM (no protocol) with symptom management medication

Group Type: SHAM_COMPARATOR

Sham Frequency specific microcurrent therapy

Intervention Type: DEVICE

Shan concussion protocol

Interventions

Frequency specific microcurrent therapy

Concussion protocol

Intervention Type: DEVICE

Sham Frequency specific microcurrent therapy

Shan concussion protocol

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

I HAN Hsiao

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Central Contacts

I HAN Hsiao

Role: CONTACT

coolfishing2002@gmail.com

+886933668642

CHEPIN CHANG

Role: CONTACT

freedyrae@gmail.com

+886934073950

Other Identifiers

CMUH112-REC3-176

Identifier Type: -

Identifier Source: org_study_id