Noninvasive Stimulation for Traumatic Brain Injury

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Norepinephrine, acetylcholine, serotonin

Disqualifiers: Neurological diseases, severe psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 days to 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how individuals with traumatic brain injuries (TBI) understand speech in noisy environments. It tests two types of noninvasive ear stimulations: cymba conchae stimulation and earlobe stimulation. Participants will receive both types of stimulation in different sequences to determine the most effective approach. Individuals who have experienced a traumatic brain injury from a blast or physical trauma and have difficulty understanding speech in noisy settings may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for TBI patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are taking medications that affect certain brain chemicals (norepinephrine, acetylcholine, and serotonin) important for the study.

What prior data suggests that this noninvasive stimulation is safe for traumatic brain injury patients?

Research shows that stimulating the Cymba Conchae is safe for patients. Studies have found it to be well-tolerated, even in people with severe brain injuries. One study noted that this type of stimulation can be safely combined with other treatments, aiding recovery without causing serious side effects.

Researchers often use earlobe stimulation as a comparison in studies, indicating its general safety. Although limited evidence supports earlobe stimulation as a primary treatment, past studies have not linked it to harmful effects.

Both treatments in this trial appear safe based on current research. However, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about noninvasive stimulation techniques for traumatic brain injury because they offer a new way to treat this complex condition. Unlike traditional treatments that often involve medications or intensive therapies, these methods use external ear stimulation, specifically at the cymba conchae and earlobe, to potentially enhance brain function without the need for drugs. This approach is unique because it targets neural pathways through gentle stimulation, which could lead to fewer side effects and a more accessible form of therapy. By focusing on these innovative techniques, researchers hope to unlock new possibilities for quicker and easier recovery for patients with traumatic brain injury.

What evidence suggests that this trial's treatments could be effective for improving speech in noise perception in traumatic brain injury?

This trial will compare Cymba Conchae stimulation with Earlobe stimulation for traumatic brain injury. Research has shown that stimulating the Cymba Conchae, a part of the ear, may enhance brain function after a traumatic brain injury. Studies found that this method improved thinking, understanding, and movement skills in brain injury models, yielding positive results in most cases. In contrast, researchers often use earlobe stimulation as a placebo in studies, suggesting it might not be as effective. Some studies have shown slight improvements with earlobe stimulation, but these aren't considered significant. Overall, Cymba Conchae stimulation appears more promising based on the available evidence. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 25-55 who either have a history of traumatic brain injury (TBI) from blast or physical trauma, or have normal hearing with no TBI history. It excludes those with recent drug abuse, other neurological diseases, severe medical conditions affecting cognition, unrelated psychiatric diseases, and contraindications to vagus nerve stimulation.

Inclusion Criteria

Proficiency in English

I am between 25 and 55 years old.

I have had a traumatic brain injury from a blast or physical trauma.

Exclusion Criteria

Current illicit or prescription drug abuse (within the last two months)

I do not have major neurological conditions like stroke or seizures.

I do not have severe illnesses like heart failure or kidney disease that affect my thinking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive noninvasive vagus nerve stimulation at two different locations on the outer ear

2 days to 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Cymba Conchae stimulation
• Earlobe stimulation

Trial Overview The study tests two noninvasive stimulations: Cymba Conchae and Earlobe stimulation. These are aimed at improving the ability to understand speech in noisy environments for individuals with TBI-related hearing difficulties.

How Is the Trial Designed?

Group I: Treatment B then Treatment A Experimental Treatment 2 Interventions

Participants will receive the stimulation at location B and then receive stimulation at location A, both on the outer ear.

Group II: Treatment A vs Treatment B Experimental Treatment 2 Interventions

Participants will receive the stimulation at location A and then receive stimulation at location B, both on the outer ear.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10133680/

Randomized trial of transcutaneous auricular vagus nerve ... This study attempts to investigate the effectiveness of taVNS in DoC by means of Coma Recovery Scale-Revised (CRS-R), Magnetic resonance imaging (MRI), ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0014488621002958

Potential roles of vagus nerve stimulation on traumatic ... The findings from those studies showed that VNS improved various brain functions in the TBI model, including cognitive and motor outcomes along with a reduction ...

3. journals.lww.com journals.lww.com/md-journal/fulltext/2022/12160/transcutaneous_auricular_vagus_nerve_stimulation.84.aspx

Transcutaneous auricular vagus nerve stimulation in... Generally, the application of taVNS in patients with DOC appears to be effective (positive results in 5 of 6 studies) and safe.

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1418937/full

The efficacy and safety of bilateral synchronous ... Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation method, which shows potential in improving recovery of DOC.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/brb3.2343

Evaluation of different vagus nerve stimulation anatomical ... The results suggest that CC and C areas are active targets for taVNS but not for earlobe, as anatomical data support. Considering that amplitude ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715921002531

Transcutaneous Vagus Nerve Stimulation in Patients With ... This study has demonstrated that tVNS delivered to the left cymba chonca is feasible and safe in patients with severe TBI. tVNS may be a promising supplementary ...

7. journals.lww.com journals.lww.com/nrronline/fulltext/2022/08000/efficacy_and_safety_of_transcutaneous_auricular.37.aspx

Efficacy and safety of transcutaneous auricular vagus ... The follow-up results over 1 year revealed that ta-VNS combined with conventional rehabilitation training greatly improved the recovery of motor and sensory ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9771208/

Transcutaneous auricular vagus nerve stimulation in disorders ... Generally, the application of taVNS in patients with DOC appears to be effective (positive results in 5 of 6 studies) and safe.

9. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1418937/pdf

The efficacy and safety of bilateral synchronous ... Transcutaneous vagus nerve stimulation in patients with severe traumatic brain injury: a feasibility trial. Neuromodulation. (2020) 23:859 ...