Atunomic NeuropathyNCT02876939
Proprioception and Sensorimotor Control in Hereditary Sensory and Autonomic Neuropathy
A study testing kinesiology tape around the hip, knee and ankle joints and No kinesiology tape around the hip, knee and ankle joints in people with Atunomic Neuropathy, run by NYU Langone Health at 1 site in United States.
Trial summary
This project comprises three sets of physiological studies - testing eight specific hypotheses - that will contribute new knowledge on proprioception and motor control in a genetic disorder that affects specific components of the sensory nervous system. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Atunomic Neuropathy
- What is being tested?
- kinesiology tape around the hip, knee and ankle joints and No kinesiology tape around the hip, knee and ankle joints
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 25 Jul 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed genetic diagnosis of HSAN III will be recruited from the Dysautonomia Center at NYU
Who cannot join
- homeless
- active drug or alcohol dependence
- evidence of neurological disorder or diabetes
- exposure to neurotoxic drugs that in the investigator's opinion may compromise results
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This project comprises three sets of physiological studies - testing eight specific hypotheses - that will contribute new knowledge on proprioception and motor control in a genetic disorder that affects specific components of the sensory nervous system.
I: To investigate the neurophysiological basis for disturbed motor control in Hereditary sensory and autonomic neuropathy (HSAN) III II: To investigate the effects of enhancing cutaneous feedback on motor control in HSAN III III: To investigate the cortical representation of proprioceptive inputs in HSAN III
Read the detailed description
HSAN III patients (n=15) and healthy control subjects (n=15) will lay supine on an MRI bed and a tungsten microelectrode inserted percutaneously into a muscle or cutaneous fascicle of the right common peroneal nerve at the fibular head, according to standard techniques employed by Prof Macefield. Neural activity will be acquired, RMS-processed (200 ms) and analysed on computer. The subject's head will be tightly enclosed in a standard clinical 32-channel SENSE head coil and headphones will be provided to minimize noise and to allow communication with the subject. The subject will be placed in the bore of a 3T whole-body scanner for 60-90 minutes.
- Conditions
- Atunomic Neuropathy
- Being tested
- kinesiology tape around the hip, knee and ankle joints, No kinesiology tape around the hip, knee and ankle joints
- Keywords
- Hereditary Sensory Neuropathy, Autonomic Neuropathy, Familial Dysautonomia, proprioception, motor control, sensory nervous system., HSAN III, IKBKAP gene mutation
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies, Dysautonomia, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiology tape around the hip, knee and ankle jointsOther
We will also demonstrate that taping the skin increases the central representation of cutaneous afferent input in HSAN III.
No kinesiology tape around the hip, knee and ankle jointsOther
Investigators will demonstrate that taping the skin increases the central representation of cutaneous afferent input in HSAN III.
| Study group | Role | What they receive |
|---|---|---|
| HSAN III | Experimental | Not described Receives: Other: kinesiology tape around the hip, knee and ankle joints; Other: No kinesiology tape around the hip, knee and ankle joints |
| Control Subjects | Active comparator | Not described Receives: Other: kinesiology tape around the hip, knee and ankle joints; Other: No kinesiology tape around the hip, knee and ankle joints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of gait in HSAN III
Measured: 120 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startNov 2016
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atunomic NeuropathyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horacio Kaufmann, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876939
- Sponsor's protocol ID
- 16-00530
- Status last verified
- Sep 2020
- First submitted
- 5 Aug 2016
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprioception and Sensorimotor Control in Hereditary Sensory and Autonomic Neuropathy
- ClinicalTrials.gov ID
- NCT02876939
- Acronym / sponsor ID
- 16-00530
- Conditions
- Atunomic Neuropathy
- Keywords
- Hereditary Sensory Neuropathy, Autonomic Neuropathy, Familial Dysautonomia, proprioception, motor control, sensory nervous system., HSAN III, IKBKAP gene mutation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 24 Aug 2016 (estimated)
- 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.
This project comprises three sets of physiological studies - testing eight specific hypotheses - that will contribute new knowledge on proprioception and motor control in a genetic disorder that affects specific components of the sensory nervous system.
I: To investigate the neurophysiological basis for disturbed motor control in Hereditary sensory and autonomic neuropathy (HSAN) III II: To investigate the effects of enhancing cutaneous feedback on motor control in HSAN III III: To investigate the cortical representation of proprioceptive inputs in HSAN III
Detailed description
HSAN III patients (n=15) and healthy control subjects (n=15) will lay supine on an MRI bed and a tungsten microelectrode inserted percutaneously into a muscle or cutaneous fascicle of the right common peroneal nerve at the fibular head, according to standard techniques employed by Prof Macefield. Neural activity will be acquired, RMS-processed (200 ms) and analysed on computer. The subject's head will be tightly enclosed in a standard clinical 32-channel SENSE head coil and headphones will be provided to minimize noise and to allow communication with the subject. The subject will be placed in the bore of a 3T whole-body scanner for 60-90 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSAN III | Experimental | Other: kinesiology tape around the hip, knee and ankle joints, Other: No kinesiology tape around the hip, knee and ankle joints |
| Control Subjects | Active comparator | Other: kinesiology tape around the hip, knee and ankle joints, Other: No kinesiology tape around the hip, knee and ankle joints |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Confirmed genetic diagnosis of HSAN III will be recruited from the Dysautonomia Center at NYU
Key exclusion criteria (5 listed)
- homeless
- active drug or alcohol dependence
- evidence of neurological disorder or diabetes
- exposure to neurotoxic drugs that in the investigator's opinion may compromise results
- Pregnant women
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 |
|---|---|---|
| kinesiology tape around the hip, knee and ankle jointsWe will also demonstrate that taping the skin increases the central representation of cutaneous afferent input in HSAN III. | Other | Control Subjects, HSAN III |
| No kinesiology tape around the hip, knee and ankle jointsInvestigators will demonstrate that taping the skin increases the central representation of cutaneous afferent input in HSAN III. | Other | Control Subjects, HSAN III |
Primary outcome
Measurement of gait in HSAN III
Time frame: 120 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
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.
Horacio Kaufmann, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesiology tape around the hip, knee and ankle joints and No kinesiology tape around the hip, knee and ankle joints in people with Atunomic Neuropathy, run by NYU Langone Health 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 22 Sep 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of gait in HSAN III (time frame: 120 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 22 Sep 2020.