Difference, IndividualNCT03506659
Electrochemical Skin Conductance in Evaluation of Chronic Neuropathy électrochimique cutanée
A study testing SUDO-SCAN Device in people with Difference, Individual, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Difference, Individual
- What is being tested?
- SUDO-SCAN Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2018to 30 Jan 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult
Who cannot join
- Patients group : Not have a chronic neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrochemical Skin Conductance in Evaluation of Chronic Neuropathy
Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers
Read the detailed description
Objective: Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers
Background:
Sudoscan is a tool developed to evaluate and screen peripheral neuropathies in diabetes. His indication has been extended to other neuropathies such as post-chemotherapy, Fabry's disease, Parkinson's disease, familial amyloid polyneuropathy.
Main objective: Evaluation of the relevance of cutaneous electrochemical conductance in chronic peripheral neuropathies.
Methodology :
Recruitment of 2 groups of 2000 patients Group 1: Patients with chronic neuropathy, during clinic bread consultation Group 2: Patients to benefit from scheduled surgery seen during anesthesia consultation For both groups filling the central awareness inventory questionnaire
Analysis of the results after the recruitment has been completed.
- Conditions
- Difference, Individual
- Being tested
- SUDO-SCAN Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUDO-SCAN DeviceDevice
Sudo-scan is a machine with 2 palets for hands and 2 palets for foots. The patient has to put his 2 hands and 2 foots on the machine. The machine do the measures during 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Test | Active comparator | 2000 patients healthy in anesthesiology consultation Receives: Device: SUDO-SCAN Device |
| Patients | Experimental | 2000 patients in pain clinic consultation Receives: Device: SUDO-SCAN Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of timing for Electrochemical skin conductance
the investigators will measure the timing between the 4 members for the Electrochemical skin conductance
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 Mar 2018
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Why it stopped: Inclusion rate too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difference, IndividualStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group open label Monocentric
- Masking
- None (open label)
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Turgay TUNA, MD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506659
- Sponsor's protocol ID
- SUDOKU
- Status last verified
- Feb 2020
- First submitted
- 15 Mar 2018
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrochemical Skin Conductance in Evaluation of Chronic Neuropathy
- ClinicalTrials.gov ID
- NCT03506659
- Acronym / sponsor ID
- SUDOKU
- Conditions
- Difference, Individual
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion rate too low
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 24 Apr 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.
Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers
Detailed description
Objective: Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers
Background:
Sudoscan is a tool developed to evaluate and screen peripheral neuropathies in diabetes. His indication has been extended to other neuropathies such as post-chemotherapy, Fabry's disease, Parkinson's disease, familial amyloid polyneuropathy.
Main objective: Evaluation of the relevance of cutaneous electrochemical conductance in chronic peripheral neuropathies.
Methodology :
Recruitment of 2 groups of 2000 patients Group 1: Patients with chronic neuropathy, during clinic bread consultation Group 2: Patients to benefit from scheduled surgery seen during anesthesia consultation For both groups filling the central awareness inventory questionnaire
Analysis of the results after the recruitment has been completed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group open label Monocentric
| Arm | Type | Receives |
|---|---|---|
| Test | Active comparator | Device: SUDO-SCAN Device2000 patients healthy in anesthesiology consultation |
| Patients | Experimental | Device: SUDO-SCAN Device2000 patients in pain clinic consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult
Key exclusion criteria (1 listed)
- Patients group : Not have a chronic neuropathy
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 |
|---|---|---|
| SUDO-SCAN DeviceSudo-scan is a machine with 2 palets for hands and 2 palets for foots. The patient has to put his 2 hands and 2 foots on the machine. The machine do the measures during 2 minutes. | Device | Patients, Test |
Primary outcome
Difference of timing for Electrochemical skin conductance
Time frame: 3 minutes
the investigators will measure the timing between the 4 members for the Electrochemical skin conductance
Results and safety
The study was stopped early (reason given: Inclusion rate too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Turgay TUNA, MD principal investigator
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUDO-SCAN Device in people with Difference, Individual, run by Erasme University Hospital at 1 site in Belgium.
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 1 inclusion and 1 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 28 Feb 2020. 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 Belgium. 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: Inclusion rate too low). 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?
Difference of timing for Electrochemical skin conductance (time frame: 3 minutes). 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 28 Feb 2020.