Degenerative Diseases, Nervous SystemNCT03389048
Performance Assessment Of The PMD-200 In Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure
A study testing PMD-200 and SLR in people with Degenerative Diseases, Nervous System, run by Medasense Biometrics Ltd at 1 site in Israel.
Trial summary
Performance assessment of the PMD-200, a novel pain monitor, in subjects with degenerative lumbar spine disease who requires surgical procedure Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Degenerative Diseases, Nervous System
- What is being tested?
- PMD-200 and SLR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Mar 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 and less than 65 (18 < Age < 65).
- The subject suffer from unilateral degenerative lumbar spine disease
- The subject suffer from leg pain only in one leg, while no pain in the other leg.
- The subject was hospitalized in the neurosurgery department of the hospital in order to undergoes spinal surgery due to the above disease
- A signed Informed Consent Form (ICF) has been obtain from the subject
Who cannot join
- The subject has a bi-lateral degenerative lumbar spine disease
- The subject is pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance Assessment of the PMD-200 (Physiological Monitor Device), a Novel Pain Monitor, in Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure
Performance assessment of the PMD-200, a novel pain monitor, in subjects with degenerative lumbar spine disease who requires surgical procedure
Read the detailed description
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.
- Conditions
- Degenerative Diseases, Nervous System
- Being tested
- PMD-200, SLR
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMD-200Device
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)
SLRDiagnostic test
With the patient lying down on his/her back, the examiner lifts the patient's leg while the knee is straight.
| Study group | Role | What they receive |
|---|---|---|
| degenerative lumbar spine disease | Experimental | patients who suffer from unilateral degenerative lumbar spine disease, undergo SLR test while being recorded by PMD-200 Receives: Device: PMD-200; Diagnostic Test: SLR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, about one year
Secondary outcomes (1)
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.
Measured: Through study completion, about one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start8 Mar 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Why it stopped: Protocol compliance and inability to support proper performance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Diseases, Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medasense Biometrics Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Soustiel, Prof., Principal investigator, Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389048
- Sponsor's protocol ID
- CLI-16-04
- Status last verified
- Mar 2020
- First submitted
- 21 Dec 2017
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Assessment of the PMD-200 (Physiological Monitor Device), a Novel Pain Monitor, in Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure
- ClinicalTrials.gov ID
- NCT03389048
- Acronym / sponsor ID
- CLI-16-04
- Conditions
- Degenerative Diseases, Nervous System
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol compliance and inability to support proper performance
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medasense Biometrics LtdUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Performance assessment of the PMD-200, a novel pain monitor, in subjects with degenerative lumbar spine disease who requires surgical procedure
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| degenerative lumbar spine disease | Experimental | Device: PMD-200, Diagnostic Test: SLRpatients who suffer from unilateral degenerative lumbar spine disease, undergo SLR test while being recorded by PMD-200 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18 and less than 65 (18 < Age < 65).
- The subject suffer from unilateral degenerative lumbar spine disease
- The subject suffer from leg pain only in one leg, while no pain in the other leg.
- The subject was hospitalized in the neurosurgery department of the hospital in order to undergoes spinal surgery due to the above disease
- A signed Informed Consent Form (ICF) has been obtain from the subject
Key exclusion criteria (2 listed)
- The subject has a bi-lateral degenerative lumbar spine disease
- The subject is pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMD-200The 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) | Device | degenerative lumbar spine disease |
| SLRWith the patient lying down on his/her back, the examiner lifts the patient's leg while the knee is straight. | Diagnostic test | degenerative lumbar spine disease |
Primary outcome
discrimination between nonpainful period to painful period
Time frame: Through study completion, about one year
To demonstrate that the NoL index can discriminate between nonpainful period to painful period, prior and following SLR test
1 secondary outcome
Correlates with changes in pain levels
Time frame: Through study completion, about one year
Results and safety
The study was stopped early (reason given: Protocol compliance and inability to support proper performance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Soustiel, Prof. principal investigator
Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMD-200 and SLR in people with Degenerative Diseases, Nervous System, run by Medasense Biometrics Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Protocol compliance and inability to support proper performance). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
discrimination between nonpainful period to painful period (time frame: Through study completion, about one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.