Healthy VolunteersNCT03253718
Technical Development of Clinical Laboratory Studies
An observational study of Healthy Volunteers, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2021to 25 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HV s will be recruited through NIH Patient Recruitment and Public Liaison Office and from our database of individuals who have participated in prior studies and are interested in being contacted for additional studies.
Who may be able to join
- Between 18 and 68 years of age
- Ability to give informed consent
- Able to understand the procedures and requirements of the study
Who cannot join
- 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 of clinical significance
- History of or current brain tumor, stroke, head trauma with loss of consciousness > few seconds, epilepsy or seizures
- Open scalp wounds or scalp infections
- For ASR, unwillingness to abstain from the use of cigarettes on the day of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy Volunteers between 18 and 68 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
STDT values in both hands
Sub-study 1: Somatosensory Temporary Discrimination Threshold (STDT): STDT values in both hands.
Measured: throughout protocol
The amount, latency and duration of muscle activity, heart rate, and skin conductance.
Sub-study 2: Acoustic Startle Reflex (ASR): The amount, latency and duration of muscle activity, heart rate, and skin conductance.
Measured: throughout protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start25 May 2021
- Primary completion25 May 2021
- Study completion25 May 2021
Why it stopped: Study withdrawn due to limited personnel, time, resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253718
- Sponsor's protocol ID
- 170150
- Other IDs
- 17-N-0150
- Status last verified
- May 2021
- First submitted
- 17 Aug 2017
- Last updated
- 27 May 2021
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Development of Clinical Laboratory Studies
- ClinicalTrials.gov ID
- NCT03253718
- Acronym / sponsor ID
- 170150
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to limited personnel, time, resources.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 25 May 2021 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy Volunteers between 18 and 68 years of age |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HV s will be recruited through NIH Patient Recruitment and Public Liaison Office and from our database of individuals who have participated in prior studies and are interested in being contacted for additional studies.
Key inclusion criteria (3 listed)
- Between 18 and 68 years of age
- Ability to give informed consent
- Able to understand the procedures and requirements of the study
Key exclusion criteria (8 listed)
- 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 of clinical significance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
STDT values in both hands
Time frame: 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.
Time frame: throughout protocol
Sub-study 2: Acoustic Startle Reflex (ASR): The amount, latency and duration of muscle activity, heart rate, and skin conductance.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Hallett, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STDT values in both hands (time frame: throughout protocol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.