Audio-visual stimulation therapy for chronic neuropathic pain: a sham-controlled randomized clinical trial, 2026, Tabacof, Putrino et al

[Utsikt]

Audio-visual stimulation therapy for chronic neuropathic pain: a sham-controlled randomized clinical trial

Spoiler: Authors

Tabacof, Laura; Howard, Rebecca; Bower, Jeffrey; Canori, Alexandra; Bond, Natasha; Breyman, Erica; Dewil, Sophie; Tosto-Mancuso, Jenna; Hanbury, Richard; Carmouche, Brandon; Robberson, Mark; Fry, Adam; Putrino, David

Abstract

Background​

Neuropathic Pain (NP) affects 10% of the general population, decreasing quality of life for millions of Americans and contributing to higher physical and mental health care costs. The most widely used treatments for NP involve medications that show limitations in efficacy and burdensome side effects.

Methods​

This randomized controlled trial explored the efficacy of a wearable Audio-Visual Stimulation neuromodulation device (Sana) as a novel intervention for chronic NP in 75 participants. Outcomes were assessed at baseline, after 8-weeks of daily use of the assigned Sana or Sham device, and after 4 weeks of discontinued use.

Results​

For the main outcome (Neuropathic Pain Symptom Inventory total), there were statistically significant improvements in the Active arm that were greater than those in the Sham Arm at Week-14 (Mean Difference = 8.75, p = 0.021).

Both groups showed significant improvements at the end of the treatment period (Week-10), and the Active arm maintained this improvement after an additional 4 weeks of non-use, while the Sham arm almost returned to baseline (Active Change = 11.7, p < = 0.001 | Sham Change = 3, p = 0.24).

Participants in the Active arm had significant decreases in use of anxiolytic, opiate, antidepressant, and anticonvulsant medications compared to the Sham arm.

Conclusions​

The study provides strong evidence supporting the efficacy of a novel AVS Device in generating durable improvements in NP, with superiority over Sham at 14 weeks. The Sana device may also reduce the reliance on pain medications and is a safe and easy to use treatment option for patients.

Web | DOI | BMC Neurology

 

[Utsikt]

The Sham device is identical in appearance and function to the AVS Device except it only delivers a constant on/off light and tone single sequence with a period of 1.5 seconds. The AVS sequence of the Sham device represents a subset of the range of AVS periods and patterns presented in the full AVS session of the AVS Device.

These design features were implemented to produce a convincing sham that would not create a risk of nocebo effects due to the possibility a participant would suspect they received the sham treatment.

Due to the similarities in design, the Sham device may function similarly to a low-dose version of the AVS device, and can produce some temporary effects on NP due to temporary relaxation effects and trial-related placebo effects.

I can’t find anything about assessing the successfulness of the blinding. I suspect it was quite easy to figure out which group you were in, effectively making it an unblinded trial.

The conflicts of interests are obvious.

4. Competing interests

At the time of submission, RHa holds the title of CEO of Sana Health, Inc, JB holds the title of VP of Analytics at Sana Health, Inc, MR holds the title of Clinical Operations at Sana Health, Inc, and NB holds the position of Head of Regulatory Affairs of Sana Health, Inc. The other authors have no conflicts of interest to declare.

5. Funding declaration

Funding for the study was provided by Sana Health, Inc.