Informed consent
Participants are told what is collected, why, and how to withdraw at any point without penalty.
Ethics and governance
IRB approved
Our research protocol holds Institutional Review Board (IRB) approval from the Institutional Review Council for Medicine (IRCM). Participation is voluntary, informed consent is obtained before any data is collected, and the protocol is reviewed on an ongoing basis.
Data handling
Face-scan processing runs on device. Identifiable data is minimised, access is restricted, and analysis sets are de-identified.
Continuing review
Protocol amendments and adverse-event reporting follow the approved IRB plan and our advisory review cycle.
IRB approval covers the conduct of research. It is not an endorsement of any product, and BRAIN.ONE is for investigational use only — not a medical device, diagnosis or treatment.
Case study
Focus Metabolics: measuring the inflammation story
Focus Metabolics develops plant-derived, non-psychoactive cannabinoid formulations — CBG and CBDA among them — aimed at inflammation balance and cellular metabolic health. Its strongest signal was also its least usable: users describing how much clearer and less inflamed they felt. Working with BRAIN.ONE, those descriptions were converted into defined, repeatable measures collected alongside objective cognitive and autonomic signals — the step that turns customer stories into a dataset a reviewer can interrogate.
- 01
Inflammation reports captured
What users described after starting a cannabinoid protocol — stiffness, foggy mornings, an afternoon crash, a week that felt clear — was logged as structured entries instead of loose testimonial notes.
- 02
Paired with measurement
Each entry was time-stamped against the same-day BRAIN.ONE record: face-scan autonomic signals, reaction time, memory span and sleep regularity.
- 03
Turned into a variable
Repeated language was coded into defined constructs — perceived inflammation load, recovery quality, mental clarity — so a subjective phrase became a scored, comparable field.
- 04
Tested within-person
Each participant serves as their own control across a 12-week series, so protocol periods are read as within-person change rather than group averages.
What changed for the brand
- Inflammation and clarity reports became structured fields with consistent definitions.
- Every report sits next to same-day cognitive and autonomic measurement.
- Formulation and protocol decisions reference a trend line rather than a recollection.
- Records are consistent enough to support review under an approved protocol.
Why it matters
Most inflammation and brain health claims live or die on anecdote, because running a traditional clinical trial is out of reach for the companies making them. The BRAIN.ONE system closes that gap at consumer scale: the same instruments, on the same cadence, for every participant, so what a person notices can be checked against what was measured. That is the difference between a testimonial and a result.
This case study describes methodology, not clinical outcomes. No claim of treatment effect is made.
Evidence pillars
Four principles behind every protocol
01
Decentralized by design
Studies run where people actually live. Participants enroll remotely and complete every measure from home, which removes the clinic bottleneck that keeps most wellness products from ever being studied at all.
02
Real-world populations
Evidence is only as good as who it was collected from. Remote enrollment lets a study reach ages, geographies and backgrounds that a single-site clinical trial rarely represents.
03
Validated digital biomarkers
A 60-second face scan, timed cognitive tasks, wearables and at-home lab panels turn subjective wellbeing into physical and digital signals that can be measured repeatedly and compared over time.
04
Explainable results
The Brain Score resolves into five dimensions rather than one opaque number, and every movement maps back to a behavior — so a finding can be read, questioned and acted on, not just quoted.
Method
How a 12-week study cycle runs
- 01
Baseline
Week 0 establishes your five-dimension baseline across cognitive tasks, face-scan derived autonomic signals, and self-report screeners.
- 02
Protocol assignment
Your profile maps to a protocol track — general longevity, dementia risk, TBI support, or autonomic recovery — with weekly targets.
- 03
Weekly re-measurement
The same instruments repeat weekly, producing a within-person trend line rather than a one-off snapshot.
- 04
Review and adaptation
Scientific and medical advisors review protocol performance in aggregate, and your plan adapts as your dimensions move.