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临床试验/NCT03253718
NCT03253718撤回不适用

Technical Development of Clinical Laboratory Studies

National Institute of Neurological Disorders and Stroke (NINDS)1 个研究点 分布在 1 个国家开始时间: 2021年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
STDT values in both hands

研究概览

简要总结

Background:

The Human Motor Control Section does tests for people with movement disorders. In order to be sure when a test is normal or abnormal, normal values must be determined in a large group of healthy volunteers (HVs). Therefore, the researchers want to study the techniques in HVs. They will use the results as the standard of comparison in future clinical studies.

Objective:

To get enough normal results in movement tests to use in clinical studies.

Eligibility:

Healthy adults ages 18-68

Design:

Participants will be screened with medical history and physical and neurological exams.

Participants will have 1 to 3 visits. They may have:

Small sticky electrodes attached to the skin on the hands/arms and neck. These will measure muscle activity.

Tiny shocks given to a finger. Participants will be asked if they felt 1 or 2 shocks. This will be done to each hand over about 30 minutes total.

A questionnaire about anxiety.

Acoustic startle reflex test. Small electrodes will be stuck to the eye, hand, and leg. Sensors will be stuck to the palms. Small metal electrodes on the chest and inner arm will measure heart rate. Participants will wear headphones. Once everything is in place, participants will hear a low sound for about 10 minutes. They will hear a short louder sound every 45 60 seconds.

详细描述

Objective

The purpose of this protocol is to get adequate normal values to compare in clinical patient studies.

Study population

There will be two techniques developed in this study: Somatosensory Temporal Discrimination Threshold (STDT) and Acoustic Startle Reflex (ASR). For both studies we will collect data systematically in an adequate sample of normal subjects.

We plan to recruit the following number of healthy volunteers (HV s) for each study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

STDT values in both hands

时间窗: throughout protocol

Sub-study 1: Somatosensory Temporary Discrimination Threshold (STDT): STDT values in both hands.

The amount, latency and duration of muscle activity, heart rate, and skin conductance.

时间窗: throughout protocol

Sub-study 2: Acoustic Startle Reflex (ASR): The amount, latency and duration of muscle activity, heart rate, and skin conductance.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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