Proprioception and Sensorimotor Control in Hereditary Sensory and Autonomic Neuropathy
Primary Purpose
Atunomic Neuropathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
kinesiology tape around the hip, knee and ankle joints
No kinesiology tape around the hip, knee and ankle joints
Sponsored by
About this trial
This is an interventional basic science trial for Atunomic Neuropathy focused on measuring Hereditary Sensory Neuropathy, Autonomic Neuropathy, Familial Dysautonomia, proprioception, motor control, sensory nervous system., HSAN III, IKBKAP gene mutation
Eligibility Criteria
Inclusion Criteria:
- Confirmed genetic diagnosis of HSAN III will be recruited from the Dysautonomia Center at NYU
Exclusion Criteria:
- 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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HSAN III
Control Subjects
Arm Description
Outcomes
Primary Outcome Measures
Measurement of gait in HSAN III
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02876939
Brief Title
Proprioception and Sensorimotor Control in Hereditary Sensory and Autonomic Neuropathy
Official Title
Proprioception and Sensorimotor Control in Hereditary Sensory and Autonomic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
July 25, 2019 (Actual)
Study Completion Date
July 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atunomic Neuropathy
Keywords
Hereditary Sensory Neuropathy, Autonomic Neuropathy, Familial Dysautonomia, proprioception, motor control, sensory nervous system., HSAN III, IKBKAP gene mutation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HSAN III
Arm Type
Experimental
Arm Title
Control Subjects
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
kinesiology tape around the hip, knee and ankle joints
Intervention Description
We will also demonstrate that taping the skin increases the central representation of cutaneous afferent input in HSAN III.
Intervention Type
Other
Intervention Name(s)
No kinesiology tape around the hip, knee and ankle joints
Intervention Description
Investigators will demonstrate that taping the skin increases the central representation of cutaneous afferent input in HSAN III.
Primary Outcome Measure Information:
Title
Measurement of gait in HSAN III
Time Frame
120 Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed genetic diagnosis of HSAN III will be recruited from the Dysautonomia Center at NYU
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horacio Kaufmann, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Proprioception and Sensorimotor Control in Hereditary Sensory and Autonomic Neuropathy
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