Trauma, HeadNCT06245967
Frequency Specific Microcurrent Therapy for Mild Traumatic Brain Injury
A study testing Frequency specific microcurrent therapy in people with Trauma, Head and Headaches Posttraumatic, run by China Medical University Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Trauma, Head, Headaches Posttraumatic, Dizziness
- What is being tested?
- Frequency specific microcurrent therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Being tested
- Frequency specific microcurrent therapy, Sham Frequency specific microcurrent therapy
- Keywords
- Frequency specific microcurrent therapy, Concussion, Traumatic brain injury
- Medical subject headings
- Craniocerebral Trauma, Post-Traumatic Headache, Dizziness, Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequency specific microcurrent therapyDevice
Concussion protocol
Sham Frequency specific microcurrent therapyDevice
Shan concussion protocol
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | True FSM (Concussion protocol) with symptom management medication Receives: Device: Frequency specific microcurrent therapy |
| Sham-control | Sham comparator | Sham FSM (no protocol) with symptom management medication Receives: Device: Sham Frequency specific microcurrent therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.5 month
Secondary outcomes (1)
the amount of medication used for symptom management
the amount of medication used for symptom management
Measured: 1.5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, HeadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I HAN Hsiao, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245967
- Sponsor's protocol ID
- CMUH112-REC3-176
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency Specific Microcurrent Therapy for Mild Traumatic Brain injury-a Single Center Double-blind Randomized Sham-controlled Trail
- ClinicalTrials.gov ID
- NCT06245967
- Acronym / sponsor ID
- CMUH112-REC3-176
- Conditions
- Trauma, Head, Headaches Posttraumatic, Dizziness, Brain Concussion, Frequency Specific Microcurrent Therapy
- Keywords
- Frequency specific microcurrent therapy, Concussion, Traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Frequency specific microcurrent therapyTrue FSM (Concussion protocol) with symptom management medication |
| Sham-control | Sham comparator | Device: Sham Frequency specific microcurrent therapySham FSM (no protocol) with symptom management medication |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frequency specific microcurrent therapyConcussion protocol | Device | Experimental |
| Sham Frequency specific microcurrent therapyShan concussion protocol | Device | Sham-control |
Primary outcome
Post-Concussion Symptom Scale (PCSS) scores
Time frame: 1.5 month
The Post-Concussion Symptom Scale (PCSS) is used to assess the number and intensity of symptoms after a concussion/mild traumatic brain injury.
1 secondary outcome
the amount of medication used for symptom management
Time frame: 1.5 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I HAN Hsiao principal investigator
China Medical University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Frequency specific microcurrent therapy in people with Trauma, Head and Headaches Posttraumatic, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I HAN Hsiao (+886933668642, coolfishing2002@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Concussion Symptom Scale (PCSS) scores (time frame: 1.5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.