Electrical Vestibular Stimulation for Migraine and Dizziness
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for people with vestibular migraine, a condition causing dizziness, imbalance, and headaches. The treatment, called electrical vestibular stimulation (EVS), uses gentle electrical signals behind the ears to improve balance and reduce symptoms. Participants will receive either the real EVS treatment or a placebo version over six sessions in two weeks. The trial aims to determine if the treatment is safe, comfortable, and potentially beneficial, paving the way for future, larger studies. Those who have experienced at least one vestibular migraine episode in the past month and can attend all sessions might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to innovative treatments for vestibular migraine.
Will I have to stop taking my current medications?
You may need to pause or keep your vestibular suppressant or migraine prevention medications at a stable dose during the two-week treatment period. You can still use rescue medications for severe attacks, but starting new medications or changing doses during the study will exclude you from the final analysis.
What prior data suggests that electrical vestibular stimulation is safe for treating vestibular migraine?
Studies have shown that electrical vestibular stimulation (EVS) is generally safe for patients. A review of multiple studies found this treatment to be safe and often effective. EVS sends gentle electrical signals behind the ears, set at a level that usually doesn't cause noticeable sensations. As a result, people typically don't feel anything uncomfortable during therapy.
While research is ongoing, current findings suggest that EVS is well-tolerated, with few or no serious side effects reported. The goal is to ensure comfortable sessions that participants can complete without issues. As a non-invasive treatment, it avoids many risks associated with more invasive procedures or medications, making it a promising option for those with vestibular migraines who haven't found relief with other treatments.12345Why are researchers excited about this trial?
Electrical Vestibular Stimulation is unique because it offers a non-invasive way to manage migraines and dizziness by delivering a low-level electrical current to the vestibular system, which is part of the inner ear responsible for balance. Unlike traditional medications that often come with side effects and require long-term use, this treatment provides continuous vestibular input without causing overt sensations, potentially reducing symptoms in a more natural way. Researchers are excited about this approach because it could offer a quicker onset of relief and a novel mechanism of action compared to existing drugs or therapies, which primarily target pain or inflammation pathways.
What evidence suggests that electrical vestibular stimulation is effective for vestibular migraine?
Research has shown that electrical vestibular stimulation (EVS) might help people experiencing dizziness due to balance issues. In one study, patients with dizziness from these problems felt better after receiving this treatment. Another study on noninvasive treatments for vestibular migraines found that most patients experienced less vertigo. This trial will compare active subthreshold stochastic electrical vestibular stimulation with sham electrical vestibular stimulation. Although these early results are promising, further research is needed to confirm its effectiveness specifically for vestibular migraines.12345
Are You a Good Fit for This Trial?
This trial is for adults with vestibular migraine, which causes repeated dizziness and headaches. Participants must be able to attend six sessions over two weeks and keep a diary of their symptoms. Details on specific inclusion or exclusion criteria are not provided.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 or sham electrical vestibular stimulation in six sessions over two weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term monitoring
Participants complete daily symptom diaries for 30 days before and 30 days after the treatment period
What Are the Treatments Tested in This Trial?
Interventions
- Electrical Vestibular Stimulation
Trial Overview
The study tests electrical vestibular stimulation (EVS), a non-drug treatment delivering gentle electrical signals behind the ears. Fifty participants will either receive real EVS or a sham treatment to compare effects on dizziness, migraines, and balance.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants randomized to the active arm will receive subthreshold wideband stochastic electrical vestibular stimulation delivered via surface electrodes placed over the mastoid region and upper neck. Stimulation will be administered while seated in six sessions over two weeks. Each session will consist of two 20 minute stimulation blocks separated by a 5 minute rest. The current waveform will be a low amplitude stochastic signal (±0.35 mA) adjusted to remain below the threshold for overt vestibular sensations while providing continuous vestibular afferent input. Participants will be free to rest, read, or use personal devices during stimulation.
Participants randomized to the sham arm will undergo identical preparation, electrode placement, and scheduling as the active group, including six seated sessions over two weeks with two 20 minute blocks and a 5 minute rest per session. At the start of each block, the stimulator will briefly ramp up to a low current to mimic the sensation of active stimulation, then be reduced to zero current for the remainder of the session, while device indicators remain active. No therapeutic level vestibular stimulation will be delivered.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Neursantys Inc
Industry Sponsor
Citations
The efficacy of vestibular electrical stimulation on patients with ...
It can be concluded that VES has positive contribution to medical treatment of patients with dizziness due to unilateral vestibular lesions; however the results ...
Exploring Mild Electrical Vestibular Stimulation as a New ...
The VM PATHI is a validated questionnaire specific to vestibular migraine that assesses six categories of patient reported outcome measures. It ...
Effects of adding transcutaneous vagus nerve stimulation ...
This parallel-group randomized clinical trial investigated the combined effects of VR and taVNS on postural control and migraine-related ...
Noninvasive Treatment Exhibits Potential Effectiveness for ...
After nVNS, vertigo symptoms improved in 13 out of 14 patients (complete resolution in 2, at least 50% improvement in 5) based off a reduction ...
Potential rescue treatment for acute vestibular migraine
19/19 patients reported improvement in vertigo severity. Mean vertigo severity was 6.6 (±2.1; median 7) before eTNS, and 2.7 (±2.6; median 3) ...
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