Vagus Nerve Stimulation for Traumatic Brain Injury

(taVNS Trial)

CT
MP
Overseen ByMackenzie Peckham, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Craig Hospital
Must be taking: Antispasticity medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called transcutaneous auricular vagus nerve stimulation (taVNS) to assist individuals with upper body weakness following a traumatic brain injury (TBI). The goal is to determine if gentle electrical stimulation to the ear, combined with physical therapy, can enhance arm and hand function and cognitive skills. Participants will be randomly assigned to receive either the active taVNS treatment or a sham (inactive) version for comparison. Individuals who have experienced a TBI, have difficulty using their arms or hands, and can attend sessions at Craig Hospital three times a week may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for TBI recovery.

What prior data suggests that this device is safe for use in traumatic brain injury rehabilitation?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe. This method gently stimulates the outer ear with mild electrical pulses. Studies have found that patients with traumatic brain injury (TBI) tolerate taVNS well, with no obvious side effects reported.

One study confirmed that taVNS is both practical and safe for patients with severe TBI, suggesting it is unlikely to cause harm. While more detailed studies are needed to fully understand its effects, current findings reassure those considering joining trials with this treatment.12345

Why are researchers excited about this trial?

Researchers are excited about transcutaneous auricular vagus nerve stimulation (taVNS) for traumatic brain injury because it offers a non-invasive way to potentially aid recovery. Unlike standard treatments that might involve medication or more invasive procedures, taVNS uses a simple earbud electrode to stimulate the vagus nerve through the skin, which could enhance brain function and support rehabilitation. This method allows for personalized adjustment of stimulation levels, making it more comfortable and adaptable for individual needs. The non-invasiveness and customization of taVNS present a promising alternative to existing therapies.

What evidence suggests that taVNS is effective for improving upper extremity function after TBI?

Research has shown that stimulating the vagus nerve through the skin of the ear (taVNS) could aid recovery from brain injuries. In this trial, participants will join either an active taVNS group or a sham taVNS group. One study found that patients with brain injuries experienced significant improvements in their abilities using this method. Another study reported that taVNS enhanced awareness and thinking skills. Although some studies noted improvements in both the active treatment and placebo groups, taVNS's ability to activate brain pathways related to learning and change makes it a promising option for rehabilitation. The treatment is generally safe and well-tolerated, with improvements observed in movement and thinking abilities.678910

Are You a Good Fit for This Trial?

This trial is for adults who have weakness or trouble using their arm and hand after a traumatic brain injury. Participants should be able to take part in rehabilitation exercises. People with certain medical devices, skin issues on the ear, or other health problems that could interfere may not be eligible.

Inclusion Criteria

Able to attend on-site training at Craig Hospital three times per week for four weeks
Able to provide informed consent
My antispasticity medication dose has not changed for at least four weeks.
See 4 more

Exclusion Criteria

Any condition or circumstance that makes participation unsafe or inappropriate as judged by the investigator
Pregnant, planning pregnancy, or breastfeeding
Concurrent participation in another drug or device trial that may interfere with this study
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous auricular vagus nerve stimulation (taVNS) paired with upper extremity functional task-specific practice (FTP) for 4 weeks

4 weeks
Multiple sessions per week

Follow-up

Participants are monitored for safety, tolerability, and preliminary effects on upper extremity function and cognition

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Trial Overview

The study compares two approaches: one group receives real electrical stimulation to the outer ear (taVNS) during rehab exercises, while another gets fake (sham) stimulation with the same therapy. The goal is to see if taVNS helps improve arm and hand function after brain injury.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: taVNS + FTPExperimental Treatment2 Interventions
Group II: sham taVNS + FTPPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Craig Hospital

Lead Sponsor

Trials
45
Recruited
8,400+

Citations

The Role of Transcutaneous Vagus Nerve Stimulation in ...

The use of tVNS is safe in patients with aSAH and stroke, and it significantly improves functional recovery in patients in a minimally conscious ...

Transcutaneous Vagus Nerve Stimulation in Patients With ...

Three patients showed improvements (>3 points) in the CRS-R following eight weeks tVNS.CONCLUSION: We demonstrated that tVNS is a feasible and safe VNS strategy ...

Non-Invasive Vagus Nerve Stimulation Improves Brain ...

By day 7, nVNS dampened cortical volume loss by 35% and 89% in the lower dose and higher dose nVNS groups, respectively, compared with the control group.

Transcutaneous auricular vagus nerve stimulation paired ...

Preliminary efficacy data showed that both active and sham taVNS groups improved across all clinical measures, but no statistical difference ...

Non-invasive Vagal Nerve Stimulation Effects on ...

“The stimulation was well tolerated and resulted in improvements in vagal tone and moderation of autonomic response to startle, consistent with ...

Transcutaneous auricular vagus nerve stimulation in ... - PMC

This comprehensive overview positions taVNS as a promising and safe modality for DOC treatment, with a focus on understanding its intricate ...

Transcutaneous Vagus Nerve Stimulation in Patients With ...

We demonstrated that tVNS is a feasible and safe VNS strategy for patients following severe TBI. Controlled studies are needed to clarify whether tVNS has a ...

Transcutaneous Auricular Vagus Nerve Stimulation to ...

Upper extremity weakness, impaired coordination, reduced dexterity, and limited arm and hand use may continue after TBI.

a sham-controlled randomized double-blind clinical trial

Recent research has shown that both taVNS and VNS have the potential to attenuate brain damage and provide neuroprotection in rats with severe brain injury.

Vagus Nerve Stimulation for TBI (taVNS Trial)

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe for people. no obvious side effects reported,