Vestibulocortical Stimulation for Pain

(VIP Trial)

Overseen By Michael Kaplan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Bipolar, Seizures, Syncope, Pregnancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new bedside technique called vestibulocortical stimulation (also known as vestibular stimulation or caloric vestibular stimulation) to determine its effectiveness in reducing pain, fatigue, and related symptoms. It focuses on individuals with fibromyalgia, chronic fatigue syndrome, long COVID, or post-treatment Lyme disease syndrome. The researchers aim to assess the treatment's effectiveness, tolerability, and duration of effects. Suitable participants have one of these conditions and can report symptoms using a smartphone or computer. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance symptom management for these challenging conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that vestibulocortical stimulation is safe for treating pain and related symptoms?

Research shows that vestibulocortical stimulation (VCS) is generally safe and well-tolerated. Studies have found that VCS can reduce pain and improve overall well-being in fibromyalgia patients. Importantly, these studies report that the procedure does not cause major side effects.

For conditions like ME/CFS, Long COVID, and post-treatment Lyme disease, VCS is also considered safe. Many sources describe it as a safe and cost-effective method, though detailed safety information for these specific conditions is limited.

Overall, VCS appears to be a promising option with a good safety record for various conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Vestibulocortical Stimulation because it offers a novel approach for addressing pain associated with conditions like Fibromyalgia, ME/CFS, Long COVID, and Post-Treatment Lyme Disease Syndrome. Unlike standard treatments, which often rely on medications such as analgesics or antidepressants, this technique targets the brain's vestibular and cortical areas to modulate pain perception directly. This method is non-invasive and could potentially provide relief without the side effects commonly associated with pharmacological treatments. Moreover, Vestibulocortical Stimulation might offer quicker and more sustainable pain management solutions by altering how the brain processes pain signals.

What evidence suggests that vestibulocortical stimulation is effective for treating pain and fatigue?

This trial will evaluate vestibulocortical stimulation (VCS) for various conditions. Studies have shown that VCS can quickly reduce pain in people with fibromyalgia, one of the conditions under study. In some trials, patients felt less pain just five minutes after receiving the treatment. For the other arm of this trial, which includes conditions like chronic fatigue syndrome, Long COVID, and post-treatment Lyme disease, early research suggests that VCS might help with symptoms such as pain and tiredness. While researchers continue to gather data, this treatment appears promising and could offer relief for these difficult-to-treat conditions. ^{1 2 3 4 5}

Who Is on the Research Team?

Michael Kaplan, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

The VIP trial is for individuals experiencing pain, fatigue, and issues with their quality of life. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions related to the study's focus.

Inclusion Criteria

I am willing to receive VCS and complete online health surveys before and after the procedure.

Owns or has access to a smart phone or computer to complete outcome measures

Provision of signed and dated informed consent form

Exclusion Criteria

I cannot lay flat on my back for 30 minutes.

Current pregnancy

I have a history of fainting.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vestibulocortical stimulation (VCS) to assess its effectiveness, tolerability, and durability in treating pain, fatigue, and related symptoms

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Vestibulocortical Stimulation

Trial Overview This trial tests vestibulocortical stimulation (VCS), a bedside technique aimed at treating symptoms like pain and fatigue. The goal is to determine VCS's effectiveness and how well patients tolerate it over time.

How Is the Trial Designed?

Group I: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Long Covid, Post Treatment Lyme Disease Syndrome Experimental Treatment 1 Intervention

Participants in this arm meet criteria for at least one of the following diseases: Myalgic-Encephalomyelitis/chronic fatigue syndrome (ME/CFS), Long COVID, or Post Treatment Lyme Disease Syndrome.

Group II: Fibromyalgia Experimental Treatment 1 Intervention

Patients in this arm meet ACR 2011 criteria for Fibromyalgia.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

Galvanic vestibular stimulation (GVS) was found to be a well-tolerated method that effectively reduced experimental pain in 16 healthy volunteers, suggesting its potential as a non-invasive pain relief technique.

The analgesic effects of GVS were more pronounced with right anodal stimulation and could be enhanced when combined with optokinetic vestibular stimulation, indicating a promising avenue for further clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical modulation of nociception by galvanic vestibular stimulation: A potential clinical tool? Hagiwara, K., Perchet, C., Frot, M., et al.[2021]

Caloric vestibular stimulation (CVS) was shown to normalize abnormal brain activity in a patient with central post-stroke pain (CPSP) and tactile allodynia, as evidenced by changes in the primary motor and anterior cingulate cortices observed through magnetoencephalography (MEG).

The study suggests that the inappropriate activation of the primary motor cortex in response to light touch in the allodynic area may be linked to a protective mechanism that is mediated by the interoceptive cortex, indicating a potential pathway for therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-stroke tactile allodynia and its modulation by vestibular stimulation: a MEG case study. McGeoch, PD., Williams, LE., Song, T., et al.[2011]

Caloric stimulation, a common method for testing the vestibular system, was shown to activate not only vestibular areas but also extravestibular regions in the brain, indicating that it can influence cortical activity beyond just balance and spatial orientation.

The study, involving six patients with complete vestibular lesions, suggests that caloric stimulation may evoke sensations of heat and pain, highlighting a potential nociceptive-visual interaction that could affect how the brain processes sensory information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in brain activation caused by caloric stimulation in the case of cochleovestibular denervation--PET study. Kisely, M., Emri, M., Lengyel, Z., et al.[2019]

Caloric vestibular stimulation (CVS) applied to the left ear significantly reduced pain intensity from laser stimulation on the left hand, indicating its potential as a method for pain relief.

The reduction in pain perception was linked to decreased neural responses in the brain's somatosensory cortex, suggesting that CVS may alter how the brain processes pain signals either through subcortical mechanisms or direct modulation of sensory processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caloric vestibular stimulation modulates nociceptive evoked potentials. Ferrè, ER., Haggard, P., Bottini, G., et al.[2022]

Galvanic vestibular stimulation (GVS) at both sub-sensory (0.6 mA) and higher (1.5 mA) levels resulted in only mild adverse effects, such as slight itching (10.2%) and tingling (10.7%), indicating that it is a safe technique for cognitive neuromodulation.

No serious adverse effects like seizures, vertigo, or nausea were reported, and both healthy individuals and stroke patients experienced similar rates and intensities of these mild effects, suggesting GVS is safe for diverse populations when conducted under safety guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minor adverse effects of galvanic vestibular stimulation in persons with stroke and healthy individuals. Utz, KS., Korluss, K., Schmidt, L., et al.[2016]

Vestibular caloric stimulation significantly improved pain in two patients suffering from central post-stroke pain syndrome, suggesting a potential new treatment approach for this challenging condition.

The proposed mechanism of action involves activation of the posterior insula, which may inhibit pain generation in the anterior cingulate, indicating a novel pathway for pain management in post-stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid relief of thalamic pain syndrome induced by vestibular caloric stimulation. Ramachandran, VS., McGeoch, PD., Williams, L., et al.[2011]

In a study involving nine patients with central post-stroke pain (CPSP), caloric vestibular stimulation (CVS) resulted in a significant average pain reduction of 2.58 points on a 10-point scale, compared to only 0.54 points for the placebo, indicating its potential efficacy in pain management.

The best responses to CVS were observed in patients whose strokes allowed activation of the dominant parieto-insular vestibular cortex, suggesting that the mechanism of action may involve interactions between vestibular stimulation and pain processing areas in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural evidence for vestibular stimulation as a treatment for central post-stroke pain. McGeoch, PD., Williams, LE., Lee, RR., et al.[2017]

Citations

1. acrabstracts.org acrabstracts.org/abstract/vestibulocortical-stimulation-with-caloric-irrigation-reduces-pain-and-improves-subjective-well-being-in-fibromyalgia-an-open-label-pilot-trial/

Vestibulocortical Stimulation with Caloric Irrigation ... Results: Of the outcome measures examined to date, the immediate effects of VCS are most evident. Overall there was a rapid pain reduction at 5 min post-VCS and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05004194?tab=table

Vestibular Caloric Stimulation and the Modulation of Pain ... This is an open label pilot study testing the potential therapeutic efficacy of vestibulocortical stimulation via cold water calorics in fibromyalgia.

3. mdpi.com mdpi.com/2227-9059/12/10/2365

Bedside Neuromodulation of Persistent Pain and Allodynia ... Pain relief in refractory fibromyalgia after vestibulocortical stimulation: An open-label pilot trial. Pain Med. 2023, 25, 252–254. [Google ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37930036/

Pain relief in refractory fibromyalgia after vestibulocortical ... Pain relief in refractory fibromyalgia after vestibulocortical stimulation: an open-label pilot trial.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06559839/vestibular-innovation-in-pain

Vestibular Innovation in Pain | Clinical Research Trial Listing The VIP trial will assess the effectiveness, tolerability, and durability of effect of vestibulocortical stimulation (VCS) - a safe ...