HealthyNCT00396890
Enhancing Brain Activity With Magnetic Stimulation
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will determine whether stimulation of the right side of the brain with repetitive transcranial magnetic stimulation (rTMS) followed by stimulation of the left side with theta burst stimulation (TBS) can temporarily change brain activity and improve hand movements in subjects more than has recently been… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Healthy
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2006to 15 Dec 2008
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-55 years
- Able to perform tasks required by the study
- Willing and able to give consent
Who cannot join
- Subjects are not eligible for this experiment if they:
- Are unable to perform the tasks
- Have history of severe alcohol or drug abuse, psychiatric illness
- Have problems with movement of the hands
- Are currently under medication with central acting drugs
- Are left-handed
Show all 9Show fewer
- Have uncontrolled medical problems, such as heart, lung or kidney disease, epilepsy, or diabetes mellitus
- Have a cardiac pacemaker, intracardiac lines, implanted medication pumps, neural stimulators, and metal in the cranium, with the exception of dental braces
- Are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Enhancing Interhemispheric Disinhibition Between Motor Cortices Using Bilateral Brain Stimulation
This study will determine whether stimulation of the right side of the brain with repetitive transcranial magnetic stimulation (rTMS) followed by stimulation of the left side with theta burst stimulation (TBS) can temporarily change brain activity and improve hand movements in subjects more than has recently been achieved with rTMS alone.
For rTMS, a wire coil is held on the patient's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. The subject may be asked to tense certain muscles slightly or perform other simple actions. The effect of TMS on the muscles is detected with small metal disk electrodes taped to the skin of the arms or legs. This study uses two kinds of rTMS. In one (Hz rTMS), magnetic pulses are given once per second for a period of 20 minutes; in the other (TBS), a series of pulses are given in bursts, each lasting 2 seconds, for a period of 3 minutes.
Read more
Healthy normal volunteers between 18 and 55 years of age may be eligible for this study. Participants undergo the following procedures during three visits to the NIH Clinical Center:
Visit 1:
Participants receive either real or sham rTMS applied on the right side of the brain followed by real or sham TBS applied on the left side of the brain. In addition, subjects undergo the following:
" Pinch force: Subjects press a wedged instrument between the thumb and index finger as hard as they can during several trials every 10 seconds.
" Speed tapping: Subjects press a key on a computer keyboard as quickly as possible for 10 seconds, repeated for several trials.
" Simple reaction time: Subjects respond as quickly as possible to a "go" signal presented on a computer monitor by performing a quick wrist movement.
" Electromyography: Subjects' muscle activity is recorded using electrodes (small metal disks) filled with conductive gel and taped to the skin over the muscle.
Visits 2 and 3
Visit 2 is scheduled for one day after visit 1, and visit 3 is one week after visit 1. Participants do not have brain stimulation during these two visits, but they have TMS measurements, behavioral measurements, and electromyography (EMG) to see if the brain stimulation done during the first visit is still present after a period of time.
At all three visits, participants comp...
Read the detailed description
OBJECTIVES:
Previous studies have demonstrated that single-pulse transcranial magnetic stimulation (TMS) applied to the primary motor cortex (MI) exerts a transient inhibitory effect on the contralateral MI. Furthermore, down-regulation of excitability in MI of one hemisphere by 1Hz rTMS results in increased excitability in the homologous MI accompanied by performance improvements in simple motor tasks performed by the hand ipsilateral to rTMS. It has been proposed that this phenomenon relies on interhemispheric disinhibition between both MI. Furthermore, interhemispheric disinhibition is also a promising method for boosting neurorehabilitation since interhemispheric disinhibition has been successfully applied in stroke patients to enhance motor cortex excitability and hand function or reduce aphasia. The purpose of this protocol is to test the hypothesis that interhemispheric disinhibition of the left MI by down-regulating activity in the right MI can be further enhanced by additional up-regulation targeting the left MI.
STUDY POPULATION:
We will study a total number of 72 healthy volunteers between the ages of 18-55.
DESIGN:
To test the hypothesis, subjects will be randomly allocated to one of 4 experimental sessions (parallel design). Subjects will receive different types of combined brain stimulation (1 Hz rTMS and Theta Burst Stimulation [TBS]) to the right and left MI. The primary outcome measure will be the amount of changes in cortical excitability, as reflected by recruitment curves (RC) of motor evoked potentials (MEPs) elicited by single-pulse TMS over the left MI. Additionally, we will test changes in short-interval intracortical inhibition (SICI) and facilitation (ICF) as well as the modulation of interhemispheric inhibition (IHI) between both MI. The secondary outcome measures will include simple motor tasks such as finger tapping, pinch force/acceleration and reaction time of the right hand.
In summary, we believe that this approach might identify additional effective strategies to enhance functional recovery after stroke and might provide deeper insight into the neural substrates involved in performance improvements after bilateral brain stimulation.
- Conditions
- Healthy
- Keywords
- Theta Burst Stimulation, Repetitive TMS (rTMS), Transcranial Magnetic Stimulation (TMS), Primary Motor Cortex, Interhemispheric Disinhibition, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study start3 Nov 2006
- Study completion15 Dec 2008
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 HealthyStudies 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
- Enrolment
- 72 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396890
- Sponsor's protocol ID
- 070022
- Other IDs
- 07-N-0022
- Status last verified
- 15 Dec 2008
- First submitted
- 7 Nov 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Boroojerdi B, Battaglia F, Muellbacher W, Cohen LG. Mechanisms influencing stimulus-response properties of the human corticospinal system. Clin Neurophysiol. 2001 May;112(5):931-7. doi: 10.1016/s1388-2457(01)00523-5.
PubMed 11336911Chen R, Classen J, Gerloff C, Celnik P, Wassermann EM, Hallett M, Cohen LG. Depression of motor cortex excitability by low-frequency transcranial magnetic stimulation. Neurology. 1997 May;48(5):1398-403. doi: 10.1212/wnl.48.5.1398.
PubMed 9153480Di Lazzaro V, Oliviero A, Mazzone P, Pilato F, Saturno E, Dileone M, Insola A, Tonali PA, Rothwell JC. Short-term reduction of intracortical inhibition in the human motor cortex induced by repetitive transcranial magnetic stimulation. Exp Brain Res. 2002 Nov;147(1):108-13. doi: 10.1007/s00221-002-1223-5. Epub 2002 Sep 18.
PubMed 12373375
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Interhemispheric Disinhibition Between Motor Cortices Using Bilateral Brain Stimulation
- ClinicalTrials.gov ID
- NCT00396890
- Acronym / sponsor ID
- 070022
- Conditions
- Healthy
- Keywords
- Theta Burst Stimulation, Repetitive TMS (rTMS), Transcranial Magnetic Stimulation (TMS), Primary Motor Cortex, Interhemispheric Disinhibition, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 3 Nov 2006
- Study completion
- 15 Dec 2008
- First posted
- 8 Nov 2006 (estimated)
- 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.
This study will determine whether stimulation of the right side of the brain with repetitive transcranial magnetic stimulation (rTMS) followed by stimulation of the left side with theta burst stimulation (TBS) can temporarily change brain activity and improve hand movements in subjects more than has recently been achieved with rTMS alone.
For rTMS, a wire coil is held on the patient's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. The subject may be asked to tense certain muscles slightly or perform other simple actions. The effect of TMS on the muscles is detected with small metal disk electrodes taped to the skin of the arms or legs. This study uses two kinds of rTMS. In one (Hz rTMS), magnetic pulses are given once per second for a period of 20 minutes; in the other (TBS), a series of pulses are given in bursts, each lasting 2 seconds, for a period of 3 minutes.
Healthy normal volunteers between 18 and 55 years of age may be eligible for this study. Participants undergo the following procedures during three visits to the NIH Clinical Center:
Visit 1:
Participants receive either real or sham rTMS applied on the right side of the brain followed by real or sham TBS applied on the left side of the brain. In addition, subjects undergo the following:
" Pinch force: Subjects press a wedged instrument between the thumb and index finger as hard as they can during several trials every 10 seconds.
" Speed tapping: Subjects press a key on a computer keyboard as quickly as possible for 10 seconds, repeated for several trials.
" Simple reaction time: Subjects respond as quickly as possible to a "go" signal presented on a computer monitor by performing a quick wrist movement.
" Electromyography: Subjects' muscle activity is recorded using electrodes (small metal disks) filled with conductive gel and taped to the skin over the muscle.
Visits 2 and 3
Visit 2 is scheduled for one day after visit 1, and visit 3 is one week after visit 1. Participants do not have brain stimulation during these two visits, but they have TMS measurements, behavioral measurements, and electromyography (EMG) to see if the brain stimulation done during the first visit is still present after a period of time.
At all three visits, participants comp...
Detailed description
OBJECTIVES:
Previous studies have demonstrated that single-pulse transcranial magnetic stimulation (TMS) applied to the primary motor cortex (MI) exerts a transient inhibitory effect on the contralateral MI. Furthermore, down-regulation of excitability in MI of one hemisphere by 1Hz rTMS results in increased excitability in the homologous MI accompanied by performance improvements in simple motor tasks performed by the hand ipsilateral to rTMS. It has been proposed that this phenomenon relies on interhemispheric disinhibition between both MI. Furthermore, interhemispheric disinhibition is also a promising method for boosting neurorehabilitation since interhemispheric disinhibition has been successfully applied in stroke patients to enhance motor cortex excitability and hand function or reduce aphasia. The purpose of this protocol is to test the hypothesis that interhemispheric disinhibition of the left MI by down-regulating activity in the right MI can be further enhanced by additional up-regulation targeting the left MI.
STUDY POPULATION:
We will study a total number of 72 healthy volunteers between the ages of 18-55.
DESIGN:
To test the hypothesis, subjects will be randomly allocated to one of 4 experimental sessions (parallel design). Subjects will receive different types of combined brain stimulation (1 Hz rTMS and Theta Burst Stimulation [TBS]) to the right and left MI. The primary outcome measure will be the amount of changes in cortical excitability, as reflected by recruitment curves (RC) of motor evoked potentials (MEPs) elicited by single-pulse TMS over the left MI. Additionally, we will test changes in short-interval intracortical inhibition (SICI) and facilitation (ICF) as well as the modulation of interhemispheric inhibition (IHI) between both MI. The secondary outcome measures will include simple motor tasks such as finger tapping, pinch force/acceleration and reaction time of the right hand.
In summary, we believe that this approach might identify additional effective strategies to enhance functional recovery after stroke and might provide deeper insight into the neural substrates involved in performance improvements after bilateral brain stimulation.
Study design
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (9 listed)
- Are unable to perform the tasks
- Have history of severe alcohol or drug abuse, psychiatric illness
- Have problems with movement of the hands
- Are currently under medication with central acting drugs
- Are left-handed
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 11336911Boroojerdi B, Battaglia F, Muellbacher W, Cohen LG. Mechanisms influencing stimulus-response properties of the human corticospinal system. Clin Neurophysiol. 2001 May;112(5):931-7. doi: 10.1016/s1388-2457(01)00523-5.
- Background: PubMed 9153480Chen R, Classen J, Gerloff C, Celnik P, Wassermann EM, Hallett M, Cohen LG. Depression of motor cortex excitability by low-frequency transcranial magnetic stimulation. Neurology. 1997 May;48(5):1398-403. doi: 10.1212/wnl.48.5.1398.
- Background: PubMed 12373375Di Lazzaro V, Oliviero A, Mazzone P, Pilato F, Saturno E, Dileone M, Insola A, Tonali PA, Rothwell JC. Short-term reduction of intracortical inhibition in the human motor cortex induced by repetitive transcranial magnetic stimulation. Exp Brain Res. 2002 Nov;147(1):108-13. doi: 10.1007/s00221-002-1223-5. Epub 2002 Sep 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 9 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: finished, as of the sponsor's last update on 2 Jul 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00396890, 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 2 Jul 2017.