Vagus Nerve Stimulation for Cerebral Palsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for adults with cerebral palsy who experience ongoing musculoskeletal pain. It will determine if a device that stimulates the vagus nerve through the ear (transcutaneous auricular vagus nerve stimulation) can reduce pain and improve quality of life. Participants will receive either the actual nerve stimulation or a sham (fake) treatment for comparison. Individuals with cerebral palsy who have experienced chronic pain for at least a year and regularly endure moderate pain might be suitable candidates. The trial aims to assess the safety and effectiveness of this treatment in managing pain. As an unphased trial, this study provides a unique opportunity to contribute to pioneering research that could lead to innovative pain management solutions.
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 it requires that your pain and/or anti-inflammatory medication dosing has been stable for at least 6 weeks before joining.
What prior data suggests that this vagus nerve stimulation technique is safe for adults with cerebral palsy?
Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS), which gently stimulates a nerve in the ear, is generally well-tolerated. In past studies, participants did not discontinue treatment due to discomfort. Only two minor side effects were reported, and these did not lead anyone to stop the treatment. Another study found that taVNS is safe and may be effective when combined with other therapies. So far, taVNS appears to be a promising and safe option for those interested in using it for cerebral palsy and pain management.12345
Why are researchers excited about this trial?
Researchers are excited about transcutaneous auricular vagus nerve stimulation (taVNS) for cerebral palsy because it offers a non-invasive way to potentially improve motor function by stimulating the vagus nerve through the ear. Current treatments for cerebral palsy often include physical therapy, medication for muscle relaxation, and sometimes surgery, but taVNS represents a novel approach by directly targeting neural pathways. Unlike these traditional methods, taVNS uses a specific delivery method that targets the cymba conchae of the left ear, which is thought to activate the vagus nerve more effectively. This innovative mechanism could lead to enhanced outcomes with fewer side effects and pave the way for new therapeutic strategies in managing cerebral palsy.
What evidence suggests that transcutaneous auricular vagus nerve stimulation is effective for cerebral palsy?
Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) might benefit people with cerebral palsy. In this trial, participants will receive either active taVNS or a sham version. Studies have found that taVNS can improve movement and sensation, which are often impaired by cerebral palsy. Early evidence also suggests it can help reduce muscle and joint pain, a common issue for those with this condition. Additionally, taVNS has been linked to better emotional well-being and quality of life. While more research is needed, these findings suggest taVNS could effectively manage cerebral palsy symptoms.23467
Are You a Good Fit for This Trial?
This trial is for adults (18+) with cerebral palsy who have had moderate or worse musculoskeletal pain (pain score 4/10 or higher) for at least a year, and whose pain medications haven't changed in the past 6 weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active taVNS or sham stimulation for 4 hours per day over a 30-day home-based protocol
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Transcutaneous Auricular Vagus Nerve Stimulation
Trial Overview
The study tests whether daily home use of a device that stimulates the vagus nerve through the ear (taVNS) can reduce chronic muscle and joint pain in people with cerebral palsy. Participants are randomly assigned to get either real stimulation or a sham version as a comparison.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants receive active transcutaneous auricular vagus nerve stimulation delivered via the cymba conchae of the left ear using the using the tVNS R device (taVNS Technologies, Erlangen, Germany) for 4 hours per day for 30 days.
Stimulation will target the ear lobe using the tVNS R device (taVNS Technologies, Erlangen, Germany) for 4 hours per day for 30 days. Stimulation will be applied to the ear lobe in order to ensure participant feel the stimulation while avoiding activation of the vagus nerve.
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Citations
Nervus Vagus Stimulation and Cerebral Palsy
The aim of this study is to investigate the potential effects of vagus nerve stimulation, which is known to influence the autonomic nervous ...
Pairing transcutaneous vagus nerve stimulation with an ...
The results of this trial will assess whether tVNS can effectively boost the effects of an intensive two-week bimanual training, in improving manual dexterity.
Pairing taVNS and CIMT is feasible and may improve upper ...
Early data is promising that taVNS paired with intensive motor CIMT is feasible, reliable, and safe in young infants with hemiplegia.
4.
ctv.veeva.com
ctv.veeva.com/study/transcutaneous-auricular-vagus-nerve-stimulation-as-a-treatment-for-musculoskeletal-pain-in-cerebralTranscutaneous Auricular Vagus Nerve Stimulation as a ...
The primary outcomes are changes in musculoskeletal pain severity and pain interference, as well as safety assessed through treatment-emergent ...
Transcutaneous Auricular Vagus Nerve Stimulation as a ...
Exploratory outcomes include health-related quality of life, depression, fatigue, spasticity, systemic inflammatory biomarkers, and blinding ...
The efficacy and safety of transcutaneous auricular vagus ...
Both auriculotherapy and vagus nerve stimulation are effective on improving cognitive functions. However, there is no double blinded randomized clinical trial ...
7.
journals.lww.com
journals.lww.com/nrronline/fulltext/2022/08000/efficacy_and_safety_of_transcutaneous_auricular.37.aspxEfficacy and safety of transcutaneous auricular vagus ...
Our research showed that ta-VNS was well tolerated, none of the participants asked to stop the treatment. Two cases of side effects were found that related to ...
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