Small Fiber NeuropathyNCT04759443
Detection of Small Fiber Neuropathy Using Skin Properties
An observational study of Small Fiber Neuropathy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Small fiber neuropathy affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, too much or too little sweating. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Fiber Neuropathy
- What is being tested?
- Image processing of skin
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with small fiber neuropathy
Who may be able to join
- Patients with age 18 year or older
- Patients that sign the informed consent form to participate in this study
- Patients completed the autonomic testing with skin biopsies
Who cannot join
- Patients with significant hairs at the legs that will cover the skin
- Any dermatological disorder that can affect the skin composition
- The use of skin lotion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
Peter Novak, MD, pnovak2@bwh.harvard.edu
About this study
Small fiber neuropathy affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, too much or too little sweating. The detection of nerve damage is complicated and not widely available; it requires either skin biopsy or specialized equipment and training. This project utilizes the mathematical processing of skin pictures for the purpose to extract the statistical features related to loss of small fibers. This approach can improve the availability of diagnosis of small fiber neuropathy.
Read the detailed description
Small fiber neuropathy, including cardiovascular diabetic neuropathy, affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, urinary problems and cold or hot intolerance. Early and accurate diagnosis of neuropathy is essential for correct treatment. Available diagnostic methods are either invasive such as skin biopsy or available only in few specialized centers. This project addresses the limited availability of small fiber neuropathy detection.
The project utilizes utilize specialized image processing of skin pictures for the purpose to extract the statistical features that are related to loss of small fibers. The accuracy of the diagnosis verified using skin biopsies.
This approach can improve the availability of diagnosis of small fiber neuropathy.
- Conditions
- Small Fiber Neuropathy
- Being tested
- Image processing of skin
- Medical subject headings
- Small Fiber Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image processing of skinOther
Image processing will be used to extract skin features that correlate with loss of small skin fibers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of image processing
The diagnostic accuracy of image processing will be evaluated by using the skin biopsy as a reference.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Jul 2021
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Fiber NeuropathyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Novak, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759443
- Sponsor's protocol ID
- 2021P000410
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2021
- Last updated
- 6 Feb 2025
- 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 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Small Fiber Neuropathy Using Skin Properties
- ClinicalTrials.gov ID
- NCT04759443
- Acronym / sponsor ID
- 2021P000410
- Conditions
- Small Fiber Neuropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 18 Feb 2021 (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.
Small fiber neuropathy affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, too much or too little sweating. The detection of nerve damage is complicated and not widely available; it requires either skin biopsy or specialized equipment and training. This project utilizes the mathematical processing of skin pictures for the purpose to extract the statistical features related to loss of small fibers. This approach can improve the availability of diagnosis of small fiber neuropathy.
Detailed description
Small fiber neuropathy, including cardiovascular diabetic neuropathy, affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, urinary problems and cold or hot intolerance. Early and accurate diagnosis of neuropathy is essential for correct treatment. Available diagnostic methods are either invasive such as skin biopsy or available only in few specialized centers. This project addresses the limited availability of small fiber neuropathy detection.
The project utilizes utilize specialized image processing of skin pictures for the purpose to extract the statistical features that are related to loss of small fibers. The accuracy of the diagnosis verified using skin biopsies.
This approach can improve the availability of diagnosis of small fiber neuropathy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with small fiber neuropathy
Key inclusion criteria (3 listed)
- Patients with age 18 year or older
- Patients that sign the informed consent form to participate in this study
- Patients completed the autonomic testing with skin biopsies
Key exclusion criteria (3 listed)
- Patients with significant hairs at the legs that will cover the skin
- Any dermatological disorder that can affect the skin composition
- The use of skin lotion
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 |
|---|---|---|
| Image processing of skinImage processing will be used to extract skin features that correlate with loss of small skin fibers. | Other | – |
Primary outcome
Diagnostic accuracy of image processing
Time frame: 2 years
The diagnostic accuracy of image processing will be evaluated by using the skin biopsy as a reference.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Small Fiber Neuropathy
Recruiting
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Sjögren's Syndrome, Small Fiber Neuropathy
Recruiting
Magnetic Brain Stimulation in Small Fiber Neuropathy
Small Fiber Neuropathy
Recruiting
Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Not yet recruitingPhase 4
Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy
Neuropathy, Small Fiber, Diabete Mellitus
Enrolling by invitation
Pilot Study to Evaluate Changes in Intra-Epidermal Nerve Fiber Density (IENFD) in Patients With Small-Fiber Neuropathy
Small Fiber Neuropathy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Fiber Neuropathy, run by Brigham and Women's Hospital at 1 site in United States.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Feb 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Novak, MD (617-732-7432, pnovak2@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of image processing (time frame: 2 years). 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 Feb 2025.