nVNS + CBD for Post-Traumatic Headache

This trial aims to determine if cannabidiol (CBD) and non-invasive vagus nerve stimulation (nVNS) can more effectively reduce the frequency of persistent headaches from past head injuries compared to traditional medications. Researchers will divide participants into three groups to test these treatments. The trial suits individuals who have experienced persistent headaches for over three months following a head injury and have at least four moderate to severe headaches per month. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to important findings.

You may need to stop or not change certain medications, especially those for headache prevention, as the study requires you not to start or change the type, dosage, or frequency of these medications. If you are using medical marijuana, cannabis, hemp, or CBD products, you must stop using them during the study.

Research shows that both non-invasive vagus nerve stimulation (nVNS) and cannabidiol (CBD) are generally safe for people.

For nVNS, studies have found it to be well-tolerated with few side effects. In one study with 102 patients, nVNS reduced symptoms like post-traumatic headache and improved various health areas. Another study found that nVNS effectively relieved pain, with benefits observed 120 minutes after use.

CBD is also known for its safety. The World Health Organization reports that CBD is generally well-tolerated. Studies show it does not cause a "high" and is safe to use without serious side effects. Its anti-inflammatory properties can be helpful for conditions like traumatic brain injury.

Researchers are excited about these treatments for post-traumatic headache because they offer novel approaches compared to typical pain relievers and preventive medications like NSAIDs, triptans, and beta-blockers. Non-Invasive Vagus Nerve Stimulation (nVNS) is unique because it uses electrical pulses to stimulate the vagus nerve, which may help regulate pain signals and reduce headache frequency without the need for medication. Cannabidiol (CBD), on the other hand, is derived from cannabis and is being investigated for its potential anti-inflammatory and analgesic properties, offering a natural alternative to traditional pharmaceuticals. These interventions could provide new hope for patients seeking relief from debilitating headaches with fewer side effects.

This trial will compare the effects of non-invasive vagus nerve stimulation (nVNS) and cannabidiol (CBD) for post-traumatic headache. Studies have shown that nVNS can significantly benefit individuals with trauma-induced headaches. In one study, patients experienced improvements in 16 out of 22 symptom areas, including headache relief. Another study found that nVNS might also enhance brain functions, such as thinking and movement, after a brain injury.