An interventional study of PMD-200 and SLR in Degenerative Diseases, Nervous System, sponsored by Medasense Biometrics Ltd. Terminated at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by Medasense Biometrics Ltd · Not applicable, Interventional, and Other
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Performance assessment of the PMD-200, a novel pain monitor, in subjects with degenerative lumbar spine disease who requires surgical procedure
The proposed study is design to further demonstrates the capability of the Nociception Level, (NoL) Index in identify and discriminate between painful event and non-painful period following pain stimulus of Straight Leg Raising (SLR) test in patients with degenerative lumbar spine disease. This feasibility study may provide first indication for a validation method that will be able to evaluate the outcome of a surgical procedure within the degenerative lumbar spine patient. Currently, there is lack of understanding of long-term outcomes after such surgeries.
In this study, the investigators plan to demonstrate that the NoL Index may serve as an indicator to the surgical procedure outcome. It will compare the objective measurement of the NoL to the patient Visual Analogue Scale (VAS) score and disability questionnaire that will characterize the subject pain perception prior and following the surgical procedure.
436 studies on the registry are indexed under Neurodegenerative Diseases; 143 are open to participants now.
This study's enrollment of 21 is below the median of 54 across 265 interventional studies indexed under Neurodegenerative Diseases.
Browse Neurodegenerative Diseases studies →Medasense Biometrics Ltd is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients who suffer from unilateral degenerative lumbar spine disease, undergo SLR test while being recorded by PMD-200
Device: PMD-200 · Diagnostic Test: SLR
The PMD-200 system is comprised of a console and designated finger probe with 4 sensors. The Sensors are Photoplethysmography (PPG) Galvanic Skin Response (GSR), Accelerometer (ACC) and Thermistor (TMP)
With the patient lying down on his/her back, the examiner lifts the patient's leg while the knee is straight.
discrimination between nonpainful period to painful period
To demonstrate that the NoL index can discriminate between nonpainful period to painful period, prior and following SLR test
Time frame: Through study completion, about one year
Correlates with changes in pain levels
To demonstrate that the NoL Index is correlates with changes in pain levels of the subject prior and following SLR.
Time frame: Through study completion, about one year
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Nov 2019, 20 months.
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This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Medasense Biometrics Ltd