Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-12-02
2028-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Surgical Cohort
Children and adolescents ages 6 to 21 years undergoing elective surgical procedures (e.g., orthopedic or thoracic surgery) with no history of chronic pain prior to surgery. Participants will undergo non-invasive nociceptive measurements using the AlgometRx Nociometer at baseline and during postoperative follow-up, alongside standard clinical pain assessments. All pain management will follow standard of care and will not be influenced by study participation.
AlgometRx Nociometer
The AlgometRx Nociometer is a non-invasive device used to measure nociceptive responses through neuroselective electrical stimulation and pupillometry. The device delivers low-intensity, painless electrical stimuli at specific frequencies to selectively activate sensory nerve fibers, while measuring stimulus-induced changes in pupil diameter. Data generated by the device are used or research measurement purposes only and do not guide or alter clinical care, treatment decisions,
Bone Marrow Transplant (BMT) Cohort
Children and adolescents aged 6 to 21 years undergoing elective surgical procedures (e.g., orthopedic or thoracic surgery) with no history of chronic pain before surgery. Participants will undergo non-invasive nociceptive measurements using the AlgometRx Nociometer at baseline and during postoperative follow-up, alongside standard clinical pain assessments. All pain management will follow the standard of care and will not be influenced by study participation.
AlgometRx Nociometer
The AlgometRx Nociometer is a non-invasive device used to measure nociceptive responses through neuroselective electrical stimulation and pupillometry. The device delivers low-intensity, painless electrical stimuli at specific frequencies to selectively activate sensory nerve fibers, while measuring stimulus-induced changes in pupil diameter. Data generated by the device are used or research measurement purposes only and do not guide or alter clinical care, treatment decisions,
Interventions
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AlgometRx Nociometer
The AlgometRx Nociometer is a non-invasive device used to measure nociceptive responses through neuroselective electrical stimulation and pupillometry. The device delivers low-intensity, painless electrical stimuli at specific frequencies to selectively activate sensory nerve fibers, while measuring stimulus-induced changes in pupil diameter. Data generated by the device are used or research measurement purposes only and do not guide or alter clinical care, treatment decisions,
Eligibility Criteria
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Inclusion Criteria
* Undergoing elective surgical procedures without a history of chronic pain, OR undergoing or planning to undergo bone marrow transplantation (BMT)
* Able to provide written informed assent and parental permission/consent, as applicable
Exclusion Criteria
* Unwilling or unable to participate
6 Years
21 Years
ALL
No
Sponsors
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VentureWell
INDUSTRY
Children's National Research Institute
OTHER
Responsible Party
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Julia Finkel
Vice chief for Pain Medicine and Research
Locations
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Children's National Hospital
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
Instrument: PROMIS Pain Intensity - Short Form 3a v1.0 | NIDA CTN Common Data Elements. https://cde.nida.nih.gov/instrument/0a481bfb-a5e6-3c84-e050-bb89ad43314d
Page MG, Katz J, Stinson J, Isaac L, Martin-Pichora AL, Campbell F. Validation of the numerical rating scale for pain intensity and unpleasantness in pediatric acute postoperative pain: sensitivity to change over time. J Pain. 2012 Apr;13(4):359-69. doi: 10.1016/j.jpain.2011.12.010. Epub 2012 Mar 15.
Wong-Baker FACES® Pain Rating Scale. (2016)
Lavoie Smith EM, Li L, Hutchinson RJ, Ho R, Burnette WB, Wells E, Bridges C, Renbarger J. Measuring vincristine-induced peripheral neuropathy in children with acute lymphoblastic leukemia. Cancer Nurs. 2013 Sep-Oct;36(5):E49-60. doi: 10.1097/NCC.0b013e318299ad23.
Barr MS, Farzan F, Davis KD, Fitzgerald PB, Daskalakis ZJ. Measuring GABAergic inhibitory activity with TMS-EEG and its potential clinical application for chronic pain. J Neuroimmune Pharmacol. 2013 Jun;8(3):535-46. doi: 10.1007/s11481-012-9383-y. Epub 2012 Jun 29.
Chouchou F, Perchet C, Garcia-Larrea L. EEG changes reflecting pain: is alpha suppression better than gamma enhancement? Neurophysiol Clin. 2021 Jun;51(3):209-218. doi: 10.1016/j.neucli.2021.03.001. Epub 2021 Mar 16.
Crawford L, Mills E, Meylakh N, Macey PM, Macefield VG, Henderson LA. Brain activity changes associated with pain perception variability. Cereb Cortex. 2023 Mar 21;33(7):4145-4155. doi: 10.1093/cercor/bhac332.
Minetama M, Kawakami M, Teraguchi M, Matsuo S, Enyo Y, Nakagawa M, Yamamoto Y, Nakatani T, Sakon N, Nagata W, Nakagawa Y. MRI grading of spinal stenosis is not associated with the severity of low back pain in patients with lumbar spinal stenosis. BMC Musculoskelet Disord. 2022 Sep 12;23(1):857. doi: 10.1186/s12891-022-05810-y.
Fomberstein K, Qadri S, Ramani R. Functional MRI and pain. Curr Opin Anaesthesiol. 2013 Oct;26(5):588-93. doi: 10.1097/01.aco.0000433060.59939.fe.
Other Identifiers
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STUDY00001386
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00001386
Identifier Type: -
Identifier Source: org_study_id
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