Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT03253718
Status:
WITHDRAWN
Last Update Posted:
2021-05-27
First Post:
2017-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Technical Development of Clinical Laboratory Studies
Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Organization:
Study Overview
Official Title:
Technical Development of Clinical Laboratory Studies
Status:
WITHDRAWN
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study withdrawn due to limited personnel, time, resources.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
STDT: 50 HV
ASR: 50 HV
Design
Subjects will come for up to 3 outpatient visits, during which they will participate in at least the STDT or the ASR. Before participation in any study, all participants will undergo screening for medical history and physical examination.
For the STDT, the index finger in both hands will be stimulated.
For the ASR, auditory stimulation will be administered at varying intervals. Subjects will also be asked to complete State Trait Anxiety Inventory (STAI) before participation in the study.
Outcome measures
STDT: discrimination threshold value
ASR: EMG response from seven muscles, heart rate, and galvanic skin response
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.
STDT: 50 HV
ASR: 50 HV
Design
Subjects will come for up to 3 outpatient visits, during which they will participate in at least the STDT or the ASR. Before participation in any study, all participants will undergo screening for medical history and physical examination.
For the STDT, the index finger in both hands will be stimulated.
For the ASR, auditory stimulation will be administered at varying intervals. Subjects will also be asked to complete State Trait Anxiety Inventory (STAI) before participation in the study.
Outcome measures
STDT: discrimination threshold value
ASR: EMG response from seven muscles, heart rate, and galvanic skin response
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 17-N-0150 | None | None | View |