A Study to Evaluate the Feasibility of a Physiologic Biomarker to Assess Pain and Other Sensory Problems Using Pupillometry in Participants With Neurofibromatosis Type 1 (NF1)

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

The 50 most recent of 366 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Notable Primary endpoint(s) modified
    • Interventions modified
    • Eligibility criteria expanded, about 10 words
    • Site details revised at 1 of 2 sites
  3. Re-verified, no change to tracked fieldsv364
  4. Study Status, Eligibilityv363
  5. Minor Site details revised at 1 of 2 sitesv362
Show 45 earlier versionsHide 45 earlier versions
  1. Re-verified, no change to tracked fieldsv361
  2. Minor Site contacts updated at 1 of 2 sitesv360
  3. Minor Study sites: 1 to 2v359
  4. Minor Start date changed from estimate of Feb 25, 2026 to Feb 18, 2026v358
  5. Minor Start date: Feb 24, 2026 to Feb 25, 2026v357
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: May 1, 2026 to May 1, 2027
    • Start date: Feb 23, 2026 to Feb 24, 2026
    v356
  7. Minor Start date: Feb 22, 2026 to Feb 23, 2026v355
  8. Minor Start date: Feb 9, 2026 to Feb 22, 2026v354
  9. Minor Start date: Feb 3, 2026 to Feb 9, 2026v353
  10. Minor Start date: Feb 2, 2026 to Feb 3, 2026v352
  11. Minor Start date: Feb 1, 2026 to Feb 2, 2026v351
  12. Minor Start date: Jan 29, 2026 to Feb 1, 2026v350
  13. Minor Start date: Jan 28, 2026 to Jan 29, 2026v349
  14. Minor Start date: Jan 27, 2026 to Jan 28, 2026v348
  15. Minor Start date: Jan 26, 2026 to Jan 27, 2026v347
  16. Minor Start date: Jan 22, 2026 to Jan 26, 2026v346
  17. Minor Start date: Jan 21, 2026 to Jan 22, 2026v345
  18. Minor Start date: Jan 20, 2026 to Jan 21, 2026v344
  19. Minor Start date: Jan 19, 2026 to Jan 20, 2026v343
  20. Minor Start date: Jan 18, 2026 to Jan 19, 2026v342
  21. Minor Start date: Jan 15, 2026 to Jan 18, 2026v341
  22. Minor Start date: Jan 14, 2026 to Jan 15, 2026v340
  23. Minor Start date: Jan 13, 2026 to Jan 14, 2026v339
  24. Minor Start date: Jan 12, 2026 to Jan 13, 2026v338
  25. Minor Start date: Jan 11, 2026 to Jan 12, 2026v337
  26. Minor Start date: Jan 8, 2026 to Jan 11, 2026v336
  27. Minor Start date: Jan 6, 2026 to Jan 8, 2026v335
  28. Minor Start date: Jan 5, 2026 to Jan 6, 2026v334
  29. Minor Start date: Jan 4, 2026 to Jan 5, 2026v333
  30. Minor Start date: Jan 1, 2026 to Jan 4, 2026v332
  31. Minor Start date: Dec 30, 2025 to Jan 1, 2026v331
  32. Minor Start date: Dec 29, 2025 to Dec 30, 2025v330
  33. Minor Start date: Dec 28, 2025 to Dec 29, 2025v329
  34. Minor Start date: Dec 25, 2025 to Dec 28, 2025v328
  35. Minor Start date: Dec 24, 2025 to Dec 25, 2025v327
  36. Minor Start date: Dec 23, 2025 to Dec 24, 2025v326
  37. Minor Start date: Dec 22, 2025 to Dec 23, 2025v325
  38. Minor Start date: Dec 21, 2025 to Dec 22, 2025v324
  39. Minor Start date: Dec 18, 2025 to Dec 21, 2025v323
  40. Minor Start date: Dec 16, 2025 to Dec 18, 2025v322
  41. Minor Start date: Dec 15, 2025 to Dec 16, 2025v321
  42. Minor Start date: Dec 14, 2025 to Dec 15, 2025v320
  43. Minor Start date: Dec 11, 2025 to Dec 14, 2025v319
  44. Minor Start date: Dec 10, 2025 to Dec 11, 2025v318
  45. Minor Start date: Dec 9, 2025 to Dec 10, 2025v317
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Neurofibromatosis type 1 (NF1) is a genetic condition that causes tumors to grow along the nerves in the skin, brain, and other parts of the body. People with NF1 often have pain and may experience other abnormal sensations like itching, numbness, or tingling. These symptoms can affect their daily life. Researchers want to learn more about these symptoms and find better ways to measure pain in people with NF1. Objective: To learn if a device called the AlgometRx Nociometer(Registered trademark) is effective in measuring pain or other abnormal sensations in people with NF1. Eligibility: People aged 1 year and older with NF1. Design: Individuals can have up to 3 assessments completed in person. Each assessment may last up to 1.0 to 1.5 hours. Individuals will be screened. They will complete questionnaires about their health and how bad their pain is. If participants are having blood drawn for other reasons, some additional samples may be used in this study. The AlgometRx Nociometer includes an electrode that will be placed onto a finger or a toe. The electrode will send non-painful electrical signals to activate nerves in the finger or toe. At the same time, a camera will be used to record changes in the pupil of the eye. The test will be done on all 4 of the participant s limbs; however, researchers may skip 1 or more limbs for various reasons. This test takes about 10 seconds to complete with at least a one-minute rest between testing different limbs. Individuals will be asked to do a 2nd assessment with the AlgometRx Nociometer that may be done 1 hour later but no more than 72 hours after the first assessment. Participants who will be returning for another visit can opt to do a 3rd assessment that will be done at least 4 weeks but not more than 18 months after the 1st....
Trial Details
NCT Number NCT06507748
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)
Neurofibromatosis Type 1
Related terms Neurofibroma, Plexiform, Neurofibromatosis 1, Pain
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov