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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02876939
Other study ID # 16-00530
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date July 25, 2019

Study information

Verified date September 2020
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date July 25, 2019
Est. primary completion date July 25, 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Atunomic Neuropathy
  • Hereditary Sensory and Autonomic Neuropathies
  • Peripheral Nervous System Diseases

Intervention

Other:
kinesiology tape around the hip, knee and ankle joints
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 joints
Investigators will demonstrate that taping the skin increases the central representation of cutaneous afferent input in HSAN III.

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of gait in HSAN III 120 Minutes