Healthy VolunteersNCT03253731
Interhemispheric Interaction of Parieto-Motor Cortico-Cortical Plasticity
An observational study of Healthy Volunteers, run by National Institute of Neurological Disorders and Stroke (NINDS).
Trial summary
Background: The two hemispheres of the brain are connected. Changes in one hemisphere affect the other through this connection. Research has shown that training new skills in one hand improves the same skills for the other hand. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Aug 2017to 9 Nov 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Volunteers
Who may be able to join
- Between the age of 18 and 55 years
- Right-handed
- English speaking
- Ability to give informed consent
Who cannot join
- Illegal drugs use within the past 6 months based on history alone
- Abnormal findings on neurologic examination
- Have more than 7 alcoholic drinks a week in the case of a woman or 14 alcoholic drinks a week in the case of a man
- History of or current brain tumor, stroke, head trauma with loss of consciousness >few seconds, epilepsy or seizures
- History of or current episode of major depression or any major psychiatric illness (axis I disorders)
- Current diagnosis of neurologic disorder
Show all 17Show fewer
- Presence of pacemaker, intracardiac lines, implanted pumps or stimulators, or metal objects inside the eye or skull. Dental fillings and dental braces are allowed.
- Open scalp wounds or scalp infection
- Employees and/or staff of HMCS/NINDS
- Taking benzodiazepines at the time of the entire study or within 12 days prior to the study. NOTE: Medication will not be stopped or held for participation in this study.
- Taking, at the time of the entire study or within 2 weeks prior to the study, any medication that acts as a central nervous system stimulant or that is known to lower seizure threshold, including, imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, foscarnet, ganciclovir, ritonavir, amphetamines, ketamine, gamma-hydroxybutyrate (GHB), theophylline, mianserin, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, reboxetine, venlafaxine, duloxetine, bupropion, mirtazapine, fluphenazine, pimozide, haloperidol, olanzapine, quetiapine, aripiprazole, ziprasidone, risperidone, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporine, chlorambucil, vincristine, methotrexate, cytosine arabinoside, BCNU, lithium, antihistamines, and sympathomimetics. NOTE: Medication will not be stopped or help for participation in this study.
- Being pregnant
- You may not be eligible to have MRI or TMS in this study if:
- You have metal in your body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if you were a welder or metal worker, since you may have small metal fragments in the eye.
- You are uncomfortable in small closed spaces (you have claustrophobia) so that you would feel uncomfortable in the MRI machine.
- You are not able to lie comfortably on your back for up to 1 hour
- You have a hearing loss reported in the history or detected in the routine physical examination
About this study
Official title: Interhemispheric Interaction of Parieto-Motor Cortico-Cortical Plasticity in Human Brain
Background:
The two hemispheres of the brain are connected. Changes in one hemisphere affect the other through this connection. Research has shown that training new skills in one hand improves the same skills for the other hand. Researchers want to learn more about how the brain works to transfer the skills to the other hand.
Read more
Objective:
To learn how changes on one side of the brain affect the other side. To study the activity of the left and right sides of the brain in healthy adults.
Eligibility:
Healthy volunteers ages 18-55 years old who are right-handed.
Design:
Participants will be screened with a medical history and physical exam. They will complete a questionnaire about their handedness. This may be done on paper or on a computer. Participants may have urine pregnancy tests.
Participants will have 2 study visits.
Participants will have a structural magnetic resonance imaging (MRI) scan. MRI uses a strong magnetic field and radio waves to take pictures of the brain. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder.
Participants will have transcranial magnetic stimulation (TMS). Two wire coils will be placed on the scalp. A brief electrical current passes through the coil and creates a magnetic pulse that affects brain activity. Participants may be asked to tense certain muscles or do simple tasks during TMS.
Participants will have electromyography. Small sticky pad electrodes will be attached to the skin on the hands. Muscle activity will be recorded during the TMS procedure.
Read the detailed description
Objective:
The purpose of this study is to evaluate the effect of long-term potentiation (LTP)-like cortical plasticity induced by parieto-motor cortico-cortical paired associative stimulation (cc-PAS) on the contralateral hemisphere and interhemispheric interactions in normal brain using dual-site transcranial magnetic stimulation (TMS). We will explore the ipsilateral and contralateral effects of cc-PAS over the left primary motor cortex (M1). We hypothesize that the motor evoked potential (MEP) at S50 (the motor evoked potential) will change after cc-PAS in the left hemisphere, which stimulates M1 after PPC (effective cc-PAS), not only on the right first dorsal interosseous (FDI) muscle, but also the left FDI muscle.
In addition, we hypothesize that the MEP at S50 will change after cc-PAS in the left hemisphere, which stimulates PPC after M1 (ineffective cc-PAS), on the right FDI muscle but not the left FDI muscle.
Study population
We intend to study 15 healthy-volunteers to have 12 who complete the study. Subjects will complete up to one screening visit and two study visits involving two intervention.
Design
Subjects will come for one screening visit and two outpatient study visits. The screening visit and the first study visit can be performed the same day. The second study visit will be done approximately 1 week after the first one. TMS-induced electromyographic (EMG) activity of hand muscles will be recorded as MEPs. Using single TMS measure on both the left and right M1, we will measure MEPs and input-out (I-O) curve for the right and left FDI muscle and abductor digiti minimi (ADM) muscle, respectively. Using a paired-pulse TMS paradigm, interhemispheric inhibition (IHI) from the left M1 to the right M1, short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF) will be measured on the left FDI and ADM muscles. Then, the subjects will undergo two plasticity induction procedures of the parieto-motor cc-PAS sessions. One of those is the hypothesized efficacious cc-PAS session and the other one is the control, a hypothesized ineffective cc-PAS session. The two sessions will be separated by approximately one week. Each session consists of 100 pairs of double stimulation to the left PPC and left M1. MEPs, I-O curve on the bilateral M1, IHI from the left M1 to the right M1, SICI and ICF will be remeasured during the 60 min after receiving cc-PAS.
Outcome measures
Primary outcome:
The primary outcome measure will be MEP amplitude from the bilateral M1 with respect to time (before, immediately and 30-45 min after intervention) after induction of cc-PAS plasticity over the left hemisphere in each session. The amplitude of MEPs on each side of M1 will be compared between before and after cc-PAS with respect to time, using ANOVA in each session.
Secondary outcome:
The degree of IHI from the left M1 to the right M1, SICI and ICF with respect to time (before, immediately and 30-45 min after intervention) will be compared by the ANOVA test. The degree of IHI and the change of IHI will be correlated with the primary outcome as measured with a correlation analysis.
- Conditions
- Healthy Volunteers
- Keywords
- Brain Plasticity, 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 | 15 healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEP amplitude at S50 over each side of M1 with respect to time (before, and immediately after and 30-45 min after cc-PAS over the left M1).
Measured: 3 timepoints
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 start11 Aug 2017
- Primary completion9 Nov 2018
- Study completion9 Nov 2018
Why it stopped: Investigator left the NIH.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- 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
- NCT03253731
- Sponsor's protocol ID
- 170151
- Other IDs
- 17-N-0151
- Status last verified
- Nov 2018
- First submitted
- 17 Aug 2017
- Last updated
- 20 Nov 2018
- Results posted
- No
Publications
Awiszus F. TMS and threshold hunting. Suppl Clin Neurophysiol. 2003;56:13-23. doi: 10.1016/s1567-424x(09)70205-3. No abstract available.
PubMed 14677378Bloom JS, Hynd GW. The role of the corpus callosum in interhemispheric transfer of information: excitation or inhibition? Neuropsychol Rev. 2005 Jun;15(2):59-71. doi: 10.1007/s11065-005-6252-y.
PubMed 16211466Arai N, Muller-Dahlhaus F, Murakami T, Bliem B, Lu MK, Ugawa Y, Ziemann U. State-dependent and timing-dependent bidirectional associative plasticity in the human SMA-M1 network. J Neurosci. 2011 Oct 26;31(43):15376-83. doi: 10.1523/JNEUROSCI.2271-11.2011.
PubMed 22031883
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interhemispheric Interaction of Parieto-Motor Cortico-Cortical Plasticity in Human Brain
- ClinicalTrials.gov ID
- NCT03253731
- Acronym / sponsor ID
- 170151
- Conditions
- Healthy Volunteers
- Keywords
- Brain Plasticity, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigator left the NIH.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 9 Nov 2018 (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 two hemispheres of the brain are connected. Changes in one hemisphere affect the other through this connection. Research has shown that training new skills in one hand improves the same skills for the other hand. Researchers want to learn more about how the brain works to transfer the skills to the other hand.
Objective:
To learn how changes on one side of the brain affect the other side. To study the activity of the left and right sides of the brain in healthy adults.
Eligibility:
Healthy volunteers ages 18-55 years old who are right-handed.
Design:
Participants will be screened with a medical history and physical exam. They will complete a questionnaire about their handedness. This may be done on paper or on a computer. Participants may have urine pregnancy tests.
Participants will have 2 study visits.
Participants will have a structural magnetic resonance imaging (MRI) scan. MRI uses a strong magnetic field and radio waves to take pictures of the brain. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder.
Participants will have transcranial magnetic stimulation (TMS). Two wire coils will be placed on the scalp. A brief electrical current passes through the coil and creates a magnetic pulse that affects brain activity. Participants may be asked to tense certain muscles or do simple tasks during TMS.
Participants will have electromyography. Small sticky pad electrodes will be attached to the skin on the hands. Muscle activity will be recorded during the TMS procedure.
Detailed description
Objective:
The purpose of this study is to evaluate the effect of long-term potentiation (LTP)-like cortical plasticity induced by parieto-motor cortico-cortical paired associative stimulation (cc-PAS) on the contralateral hemisphere and interhemispheric interactions in normal brain using dual-site transcranial magnetic stimulation (TMS). We will explore the ipsilateral and contralateral effects of cc-PAS over the left primary motor cortex (M1). We hypothesize that the motor evoked potential (MEP) at S50 (the motor evoked potential) will change after cc-PAS in the left hemisphere, which stimulates M1 after PPC (effective cc-PAS), not only on the right first dorsal interosseous (FDI) muscle, but also the left FDI muscle.
In addition, we hypothesize that the MEP at S50 will change after cc-PAS in the left hemisphere, which stimulates PPC after M1 (ineffective cc-PAS), on the right FDI muscle but not the left FDI muscle.
Study population
We intend to study 15 healthy-volunteers to have 12 who complete the study. Subjects will complete up to one screening visit and two study visits involving two intervention.
Design
Subjects will come for one screening visit and two outpatient study visits. The screening visit and the first study visit can be performed the same day. The second study visit will be done approximately 1 week after the first one. TMS-induced electromyographic (EMG) activity of hand muscles will be recorded as MEPs. Using single TMS measure on both the left and right M1, we will measure MEPs and input-out (I-O) curve for the right and left FDI muscle and abductor digiti minimi (ADM) muscle, respectively. Using a paired-pulse TMS paradigm, interhemispheric inhibition (IHI) from the left M1 to the right M1, short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF) will be measured on the left FDI and ADM muscles. Then, the subjects will undergo two plasticity induction procedures of the parieto-motor cc-PAS sessions. One of those is the hypothesized efficacious cc-PAS session and the other one is the control, a hypothesized ineffective cc-PAS session. The two sessions will be separated by approximately one week. Each session consists of 100 pairs of double stimulation to the left PPC and left M1. MEPs, I-O curve on the bilateral M1, IHI from the left M1 to the right M1, SICI and ICF will be remeasured during the 60 min after receiving cc-PAS.
Outcome measures
Primary outcome:
The primary outcome measure will be MEP amplitude from the bilateral M1 with respect to time (before, immediately and 30-45 min after intervention) after induction of cc-PAS plasticity over the left hemisphere in each session. The amplitude of MEPs on each side of M1 will be compared between before and after cc-PAS with respect to time, using ANOVA in each session.
Secondary outcome:
The degree of IHI from the left M1 to the right M1, SICI and ICF with respect to time (before, immediately and 30-45 min after intervention) will be compared by the ANOVA test. The degree of IHI and the change of IHI will be correlated with the primary outcome as measured with a correlation analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –15 healthy volunteers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Volunteers
Key inclusion criteria (4 listed)
- Between the age of 18 and 55 years
- Right-handed
- English speaking
- Ability to give informed consent
Key exclusion criteria (17 listed)
- Illegal drugs use within the past 6 months based on history alone
- Abnormal findings on neurologic examination
- Have more than 7 alcoholic drinks a week in the case of a woman or 14 alcoholic drinks a week in the case of a man
- History of or current brain tumor, stroke, head trauma with loss of consciousness >few seconds, epilepsy or seizures
- History of or current episode of major depression or any major psychiatric illness (axis I disorders)
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
MEP amplitude at S50 over each side of M1 with respect to time (before, and immediately after and 30-45 min after cc-PAS over the left M1).
Time frame: 3 timepoints
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 20 Nov 2018.
- Background: PubMed 14677378Awiszus F. TMS and threshold hunting. Suppl Clin Neurophysiol. 2003;56:13-23. doi: 10.1016/s1567-424x(09)70205-3. No abstract available.
- Background: PubMed 16211466Bloom JS, Hynd GW. The role of the corpus callosum in interhemispheric transfer of information: excitation or inhibition? Neuropsychol Rev. 2005 Jun;15(2):59-71. doi: 10.1007/s11065-005-6252-y.
- Background: PubMed 22031883Arai N, Muller-Dahlhaus F, Murakami T, Bliem B, Lu MK, Ugawa Y, Ziemann U. State-dependent and timing-dependent bidirectional associative plasticity in the human SMA-M1 network. J Neurosci. 2011 Oct 26;31(43):15376-83. doi: 10.1523/JNEUROSCI.2271-11.2011.
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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)
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).
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 4 inclusion and 17 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 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
MEP amplitude at S50 over each side of M1 with respect to time (before, and immediately after and 30-45 min after cc-PAS over the left M1). (time frame: 3 timepoints). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03253731, which also lists 3 linked publications.
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 20 Nov 2018.