Frequency Specific Microcurrent Therapy for Mild Traumatic Brain Injury

NCT06245967 | Not Yet Recruiting

• 1 other identifier: CMUH112-REC3-176
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Keywords

Frequency specific microcurrent therapy; Concussion; Traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the amount of medication used for symptom management

  1.5 month

Study Arms (2)

Experimental

EXPERIMENTAL

True FSM (Concussion protocol) with symptom management medication

Device: Frequency specific microcurrent therapy

Sham-control

SHAM COMPARATOR

Sham FSM (no protocol) with symptom management medication

Device: Sham Frequency specific microcurrent therapy

Interventions

Frequency specific microcurrent therapy DEVICE

Concussion protocol

Experimental

Sham Frequency specific microcurrent therapy DEVICE

Shan concussion protocol

Sham-control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20 and 65, inclusive, for both males and females.
• 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.
• Presence of persistent post-concussion symptoms starting from the day of injury and lasting for more than ten days.
• Complete consciousness or decision-making capacity at the time of enrollment.
• 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.

You may not qualify if:

• Individuals below 20 years or above 65 years of age, regardless of gender.
• History of traumatic brain injury with a loss of consciousness exceeding 30 minutes, initial Glasgow Coma Scale (GCS) score less than 13.
• Not a first-time occurrence of traumatic brain injury.
• 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.
• Presence of comorbidities such as cancer, depression.

Sponsors & Collaborators

• China Medical University Hospital: lead

MeSH Terms

Conditions

Craniocerebral Trauma; Post-Traumatic Headache; Dizziness; Brain Concussion; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• I HAN Hsiao

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

I HAN Hsiao

CONTACT

+886933668642; coolfishing2002@gmail.com

CHEPIN CHANG

CONTACT

+886934073950; freedyrae@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: February 15, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share