Evidence & Research

Clinical Evaluation

As well as thousands of hours of testing, Alevia’s effectiveness is backed by extensive clinical data. Three clinical trials involving 150 patients and 12,000 treatments have been conducted.

3

CLINICAL TRIALS

150+

PATIENTS

12,000+

TREATMENTS

REGIONAL STUDY

Chronic Pain Study (UK)

A recent UK study has confirmed the exciting potential of Vermillion Health’s breakthrough treatment for chronic pain management. Conducted from mid-2020 until early 2021, patients reported significant reductions in their levels of pain, anxiety and depression. At the same time, they reported improvements in sleep, mood and quality of life.

Furthermore, the improvements from the eight weeks of neurofeedback training were sustained at follow-up points – 4, 12 and 26 weeks. The full results of the trial are expected to be published shortly in a medical journal.

The UK study was intentionally small-scale, involving 16 patients, to serve as a proof-of-concept for the system and lay the groundwork for further research.

PRIMARY OUTCOME

Alevia as a Pain Management System

Clinical studies of Alevia have primarily focused on managing chronic pain. In these trials, patients rated their pain levels before and after treatment using a widely recognized 10-point scale.

A 2-point reduction on this scale is considered a significant improvement in pain intensity [1]. By analyzing the results of multiple trials, we found that Alevia users, on average, experienced a 2-point decrease in their average pain intensity (from 5.6 to 3.6).

Average Pain Intensity

5.6

➜

3.6

2-point reduction on a 10-point scale

Worst & Average Pain

6.3

➜

4.3

2-point reduction on a 10-point scale

80%

of trial participants reported an improvement in at least one pain rating.

PRIMARY OUTCOME

Additional Benefits of the Alevia System

As well as the pain ratings, patients were monitored to see if Alevia affected other aspects of their lives, such as mental health (depression, anxiety, and stress), increased activity and sleep.

97 %

of participants reported improvements in at least one or more of eight different quality-of-life measures tracked.

70 %

saw improvements in mental health, anxiety, depression, and sleep.

These results suggest that the Alevia system may have a multifaceted role in improving the overall well-being of people with chronic pain. Even when pain scores may not have significantly improved, the positive impact on quality of life 0- including increased ability to engage in day-to-day activities and returning to work – can be significant.

RESULTS

Aggregated Trial Data

The following graphics represent aggregated results across all trials where comparable data is available.

Chronic Pain Conditions Treated

Age and Sex Distribution

Health Outcome Measures

PRESENTATIONS

Clinical Highlights

As well as the pain ratings, patients were monitored to see if Alevia affected other aspects of their lives, such as mental health (depression, anxiety, and stress), increased activity and sleep.

International Neuromodulation Society Conference – Case Report

03.11.2023

Christine Ozolins, Chief Science Officer at Vermillion Health, presented a case report poster at the International Neuromodulation Society Conference in Hamburg, Germany, showcasing early clinical insights from the Alevia neurofeedback system.

BSPRM Conference – Chronic Pain Case Study

25.11.2024

Christine Ozolins presented a home-based EEG neurofeedback case study at the British Society of Physical and Rehabilitation Medicine (BSPRM). A 56-year-old participant with 30 years of chronic primary pain reported reduced pain, improved mood, and increased activity, demonstrating the potential of the Alevia system as a safe, non-invasive home treatment.

PEER REVIEWED

Publications

Exploring Alevia’s Potential in Neuropathic Pain Relief: A Pilot Study with 10 Neuropathic Pain Patients in Collaboration with UK NHS.
- • Publication (Archives of Rehabilitation Research and Clinical Translation, 2024) – https://www.archives-rrct.org/arti…
Alevia for the treatment of Chronic Migraine: A Mixed Methods Case Report.
- • Publication (Neuromodulation, 2023) – https://www.neuromodulationjourna…
- • Presented at the International Neuromodulation Society Conference, 2023 – https://www.researchgate.net/publ…
Alevia for the treatment of Neuropathic Pain: A Mixed Methods Case Report.
- • Presented at the Multidisciplinary Association for Spinal Cord Injury Professionals 25^th Annual Conference, 2023 – https://www.researchgate.net/publ…
Home-based Axon for Chronic Pain Management: Proof-of-Concept trial with 16 chronic pain patients in the UK.
- • Publication (Frontiers in Pain, 2022) – https://www.frontiersin.org/artic…
Alevia Intervention for Pain: A Case Study.
- • Presented at the International Association for the Study of Pain (IASP) Conference, 2021 – https://www.researchgate.net/publ…
Alevia neurofeedback altered brain activity and effectively reduced pain: A case series of Chronic Pain Patients.
- • Presented at the Neuromodulation Society of Australia and New Zealand (NSANZ) Conference, 2021 – https://www.researchgate.net/publ…

References: [1] S. M. Smith et al., “Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations,” Pain, vol. 161, no. 11, pp.

The results are conclusive

Alevia is safe and effective. Learn more about how it works or get in touch.