search
Back to results

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
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

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

16 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 5, 2016
Last Updated
September 18, 2020
Sponsor
NYU Langone Health
search

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

We'll reach out to this number within 24 hrs