{
  "sourceDate": "2026-09-24",
  "dataCut": "2026-09-22",
  "status": "Company-provided manuscript draft, prepared for submission. Not independent validation or proof of publication.",
  "sourceTitle": "AI-Modulated, EEG-Guided Transcutaneous Electrical Neuromodulation Versus Standard Interferential Current Therapy for Chronic Pain: A Randomized, Double-Blind, Active-Controlled Phase II Trial",
  "site": "Puerto Vallarta, Jalisco, Mexico",
  "participants": 333,
  "sessions": 817,
  "maxSessions": 3,
  "sessionMinutes": 30,
  "medianCourseDays": 3,
  "comparator": "active ICT",
  "followUpBeyondLastSession": false,
  "primaryEndpoint": "Baseline pain to last observed immediate post-session pain, on a 0–10 scale",
  "arms": {
    "biocurrent": {
      "n": 228,
      "sessions": 584,
      "attendance": [
        228,
        195,
        161
      ],
      "baseline": 5.75,
      "lastScore": 0.83,
      "meanReduction": 4.92,
      "reductionCI": [
        4.62,
        5.23
      ],
      "responders": 214,
      "responderPercent": 93.9,
      "zeroPain": 139,
      "zeroPainPercent": 61,
      "firstReduction": 3.83,
      "firstResponders": 177,
      "firstResponderPercent": 77.6,
      "completerPercent": 70.6
    },
    "ict": {
      "n": 105,
      "sessions": 233,
      "attendance": [
        105,
        72,
        56
      ],
      "baseline": 5.9,
      "lastScore": 2.9,
      "meanReduction": 3,
      "reductionCI": [
        2.56,
        3.45
      ],
      "responders": 61,
      "responderPercent": 58.1,
      "zeroPain": 21,
      "zeroPainPercent": 20,
      "firstReduction": 1.78,
      "firstResponders": 31,
      "firstResponderPercent": 29.5,
      "completerPercent": 53.3
    }
  },
  "baselineAdjustedDifference": {
    "mean": 2.03,
    "ci": [
      1.66,
      2.4
    ],
    "p": "<0.001"
  },
  "limitations": [
    "Single sponsor-conducted site",
    "Immediate pain ratings only, without longer-term follow-up or functional outcomes",
    "Unequal attendance and unrecorded reasons for non-return",
    "Active ICT comparator, no inert sham",
    "Blinding integrity not formally tested",
    "Trial not publicly registered according to the manuscript",
    "Adverse events were not captured on a structured case report form"
  ],
  "safety": "The manuscript reports no recorded adverse events across 817 sessions. This does not establish safety or exclude unobserved, uncommon or delayed risks."
}