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

65 Participants Needed

Trial Summary

What is the purpose of this trial?

The VIP trial will assess the effectiveness, tolerability, and durability of effect of vestibulocortical stimulation (VCS) - a safe \& cost-effective bedside technique - in treating pain, fatigue \& related symptoms using validated patient-reported outcomes. Data from this trial will be used to guide optimized treatment protocols in future randomized controlled trials and help inform the implementation of VCS into standard clinical practice.

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 data supports the effectiveness of the treatment Vestibulocortical Stimulation for pain?

Research shows that caloric vestibular stimulation (CVS), a component of vestibulocortical stimulation, can reduce pain in conditions like central post-stroke pain and thalamic pain syndrome. Studies indicate that CVS can lower pain intensity and modulate pain perception by affecting brain areas involved in processing pain signals. ^{1 2 3 4 5}

Is vestibulocortical stimulation safe for humans?

Vestibulocortical stimulation, including methods like caloric vestibular stimulation (CVS) and galvanic vestibular stimulation (GVS), has been studied for its effects on pain and other conditions. While CVS can cause some undesirable effects in certain patients, GVS has been explored as a potentially safer alternative. However, systematic studies on the adverse effects of GVS are limited, and minor adverse effects have been noted in both stroke patients and healthy individuals. ^{3 4 5 6 7}

How is Vestibulocortical Stimulation different from other pain treatments?

Vestibulocortical Stimulation is unique because it uses the body's balance system to help reduce pain by modulating brain activity, unlike traditional pain treatments that often target pain directly. This method can influence pain perception by activating specific brain areas, potentially offering relief for conditions that are hard to treat with standard therapies. ^{2 3 4 5 6}

Research Team

Michael Kaplan, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Behavioural evidence for vestibular stimulation as a treatment for central post-stroke pain. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Rapid relief of thalamic pain syndrome induced by vestibular caloric stimulation. [2011]

3. Denmark pubmed.ncbi.nlm.nih.gov

Post-stroke tactile allodynia and its modulation by vestibular stimulation: a MEG case study. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Cortical modulation of nociception by galvanic vestibular stimulation: A potential clinical tool? [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Caloric vestibular stimulation modulates nociceptive evoked potentials. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Changes in brain activation caused by caloric stimulation in the case of cochleovestibular denervation--PET study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Minor adverse effects of galvanic vestibular stimulation in persons with stroke and healthy individuals. [2016]