Technical Development of Clinical Laboratory Studies
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 68 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | December 31, 2019 |
| Contact: | Elaine P Considine, R.N. |
| Email: | considinee@ninds.nih.gov |
| Phone: | (301) 435-8518 |
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 or 2 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 or 2 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....
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 2 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 2 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
- INCLUSION CRITERIA:
- Between 18 and 68 years of age
- Ability to give informed consent
- Able to understand the procedures and requirements of the study
EXCLUSION CRITERIA:
- Diagnosis of a neurological disorder
- Illegal drug use within the past six months. The intent is to exclude those with drug
use that may affect study results
- Self-reported consumption of >7 alcoholic drinks a week for women and >14 alcoholic
drinks a week for men
- Unwillingness to abstain from caffeine or alcohol on the day of the study
- Abnormal findings on neurological exam
- History of or current brain tumor, stroke, head trauma with loss of consciousness >
few seconds, epilepsy or seizures
- For ASR, self-reported hearing loss of more than 30dB
- Open scalp wounds or scalp infections
- For ASR, unwillingness to abstain from the use of cigarettes on the day of the study
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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