Repetitive TMS (rTMS)NCT01747200
Effects of Transcranial Magnetic Stimulation on Object Recognition
A study testing Bilateral rTMS at same frequency and in phase, Bilateral rTMS at different frequencies and Bilateral rTMSat same frequency and out of phase in people with Repetitive TMS (rTMS) and Sham rTMS, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: The brain has natural rhythms called brain waves. An electroencephalogram (EEG) can record these rhythms. When people identify the picture of a familiar object shown on a computer screen, the communication between certain regions of the brain increases. An EEG can detect these communication brain waves. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Repetitive TMS (rTMS), Sham rTMS, Bilateral rTMS
- What is being tested?
- Bilateral rTMS at same frequency and in phase, Bilateral rTMS at different frequencies and Bilateral rTMSat same frequency and out of phase
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2012to 26 Jan 2017
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 - 70 years.
- Able to give his/her own consent to participate in the study.
Who cannot join
- Presence of cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, metal fragments in the eye.
- Pregnancy or lactation.
- History of any serious medical illness or hearing problems
- Intake of medication that affect the central nervous system like anti depressants, antihistamines, antipsychotics, dopamine agonists, benzodiazepines and antiepileptics in the past 3 months.
- Presence of neurological or psychiatric illnesses like brain tumor, migraine, depression, bipolar disorder, schizophrenia.
- History of any seizure.
Show all 11Show fewer
- Use or abuse of any drug in the past 6 months or intake of more than 7 alcoholic drinks a week in females and more than 14 alcoholic drinks a week in males.
- Presence of metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or metal fragments in the eye as these make having an MRI unsafe.
- Presence of metallic dental fillings which are likely to cause MRI artifacts
- Uncomfortable being in a small space for up to 2 hours.
- Unable to lie flat on the back for up to 2 hours
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: Modulating Behavior in Humans by Entrainment With Rhythmic Transcranial Magnetic Stimulation
Background:
- The brain has natural rhythms called brain waves. An electroencephalogram (EEG) can record these rhythms. When people identify the picture of a familiar object shown on a computer screen, the communication between certain regions of the brain increases. An EEG can detect these communication brain waves. Transcranial magnetic stimulation (TMS) can affect these brain waves by slightly changing the brain s rhythms. Researchers want to see if changing brain rhythms with TMS interferes with the ability to identify pictures of familiar objects. This study will provide more information about how TMS can affect brain waves and behavior.
Read more
Objectives:
- To see if TMS can interfere with the brain s ability to identify pictures of familiar objects.
Eligibility:
- Healthy volunteers between 18 and 70 years of age.
Design:
- This study requires two visits to the clinical center. The first visit will last about 2 hours. The second visit will last about 4 hours.
- Participants will be screened with a physical exam and medical history.
- At the first visit, participants will have an object recognition test. Participants will look at pictures of several objects on a computer screen. They will then have to state whether the objects they see on the screen are familiar. The object recognition test will be done along with TMS.
- At the second visit, participants will have an EEG while taking the object recognition test. Brain waves will be monitored during the test. They will then repeat the test while having repetitive TMS to study its effect on object recognition. The participants will then take the object recognition test alone for a final time. This will make sure that TMS effects (if any) on the ability to identify familiar object images are no longer present.
Read the detailed description
Inter-hemispheric coherence (IHC) is one of the electroencephalography (EEG) parameters that measures synchronization of oscillations originating from brain regions of different hemispheres and thereby the functional connectivity between them. We know that object discrimination is associated with transient increase in IHC. In this study we will interfere with the transient IHC that is associated with midline object discrimination by using rhythmic repetitive transcranial magnetic stimulation (rTMS).
We will study the effects of entrainment by unilateral or bilateral, synchronous or asynchronous TMS pulses on behavior. The goal of the study is to determine if entrainment by TMS will affect task performance. If the results show that TMS by entrainment influenced behavior, then we can expect TMS to be a useful technique to explore the behavioral impact of specific neuronal oscillations under physiological as well as pathological conditions. Further, TMS could also find applications in rehabilitation or treatment of behavioral symptoms in patients with neuropsychiatric diseases.
STUDY POPULATION:
We intend to study 11 adult healthy volunteers on an outpatient basis.
STUDY DESIGN:
All the subjects will first participate in a screening session where the threshold TMS intensity for blocking object discrimination and the optimal coil orientation will be determined using single pulse TMS. Later they will attend the main experiment session where they will be asked to perform the object discrimination task in four blocks, of which the second, third and fourth will be in random order. During the first block, the individual coherence frequency will be determined by recording EEG during the task. During the second, third and fourth blocks, the subjects will receive either unilateral, bilateral or sham rTMS in a random order while EEG is being recorded. Short trains of 7 TMS pulses will be delivered during each trial. TMS pulses will be administered over left and/or right LOG at 80% of threshold intensity blocking object discrimination or 60% maximum stimulator output whichever is smaller.
OUTCOME MEASURES:
We expect that short trains of TMS will affect IHC depending on whether the pulses are synchronous or asynchronous. By modulating IHC, we expect changes in object discrimination task performance. The primary outcome measure in this study includes object discrimination task performance. During the study, we will also compute the individual frequency at which maximum coherence occurs, the threshold intensity and optimal coil direction for blocking object discrimination and the spatio-temporal characteristics of EEG waves during the rTMS trains to confirm that entrainment is occurring.
- Conditions
- Repetitive TMS (rTMS), Sham rTMS, Bilateral rTMS, Unilateral rTMS
- Being tested
- Sham rTMS, Bilateral rTMS at same frequency and in phase, Bilateral rTMS at different frequencies, Bilateral rTMSat same frequency and out of phase, rTMS over TP8
- Keywords
- Repetitive TMS (rTMS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham rTMSProcedure or surgery
Bilateral rTMS at same frequency and in phaseProcedure or surgery
Bilateral rTMS at different frequenciesProcedure or surgery
Bilateral rTMSat same frequency and out of phaseProcedure or surgery
rTMS over TP8Procedure or surgery
rTMS over TP7Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of correct responses in the midline object recognition task.
Measured: 4 hours
Secondary outcomes (1)
Threshold intensity for blocking object recognition
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study start16 Nov 2012
- Primary completion26 Jan 2017
- Study completion26 Jan 2017
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 Repetitive TMS (rTMS)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Enrolment
- 13 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
- NCT01747200
- Sponsor's protocol ID
- 130035
- Other IDs
- 13-N-0035
- Status last verified
- 26 Jan 2017
- First submitted
- 8 Dec 2012
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Adler G, Brassen S, Jajcevic A. EEG coherence in Alzheimer's dementia. J Neural Transm (Vienna). 2003 Sep;110(9):1051-8. doi: 10.1007/s00702-003-0024-8.
PubMed 12928837Gerloff C, Andres FG. Bimanual coordination and interhemispheric interaction. Acta Psychol (Amst). 2002 Jun;110(2-3):161-86. doi: 10.1016/s0001-6918(02)00032-x.
PubMed 12102104Gray CM, Singer W. Stimulus-specific neuronal oscillations in orientation columns of cat visual cortex. Proc Natl Acad Sci U S A. 1989 Mar;86(5):1698-702. doi: 10.1073/pnas.86.5.1698.
PubMed 2922407
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
- Modulating Behavior in Humans by Entrainment With Rhythmic Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT01747200
- Acronym / sponsor ID
- 130035
- Conditions
- Repetitive TMS (rTMS), Sham rTMS, Bilateral rTMS, Unilateral rTMS
- Keywords
- Repetitive TMS (rTMS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 16 Nov 2012
- Primary completion
- 26 Jan 2017 (actual)
- Study completion
- 26 Jan 2017 (actual)
- First posted
- 11 Dec 2012 (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.
Background:
- The brain has natural rhythms called brain waves. An electroencephalogram (EEG) can record these rhythms. When people identify the picture of a familiar object shown on a computer screen, the communication between certain regions of the brain increases. An EEG can detect these communication brain waves. Transcranial magnetic stimulation (TMS) can affect these brain waves by slightly changing the brain s rhythms. Researchers want to see if changing brain rhythms with TMS interferes with the ability to identify pictures of familiar objects. This study will provide more information about how TMS can affect brain waves and behavior.
Objectives:
- To see if TMS can interfere with the brain s ability to identify pictures of familiar objects.
Eligibility:
- Healthy volunteers between 18 and 70 years of age.
Design:
- This study requires two visits to the clinical center. The first visit will last about 2 hours. The second visit will last about 4 hours.
- Participants will be screened with a physical exam and medical history.
- At the first visit, participants will have an object recognition test. Participants will look at pictures of several objects on a computer screen. They will then have to state whether the objects they see on the screen are familiar. The object recognition test will be done along with TMS.
- At the second visit, participants will have an EEG while taking the object recognition test. Brain waves will be monitored during the test. They will then repeat the test while having repetitive TMS to study its effect on object recognition. The participants will then take the object recognition test alone for a final time. This will make sure that TMS effects (if any) on the ability to identify familiar object images are no longer present.
Detailed description
Inter-hemispheric coherence (IHC) is one of the electroencephalography (EEG) parameters that measures synchronization of oscillations originating from brain regions of different hemispheres and thereby the functional connectivity between them. We know that object discrimination is associated with transient increase in IHC. In this study we will interfere with the transient IHC that is associated with midline object discrimination by using rhythmic repetitive transcranial magnetic stimulation (rTMS).
We will study the effects of entrainment by unilateral or bilateral, synchronous or asynchronous TMS pulses on behavior. The goal of the study is to determine if entrainment by TMS will affect task performance. If the results show that TMS by entrainment influenced behavior, then we can expect TMS to be a useful technique to explore the behavioral impact of specific neuronal oscillations under physiological as well as pathological conditions. Further, TMS could also find applications in rehabilitation or treatment of behavioral symptoms in patients with neuropsychiatric diseases.
STUDY POPULATION:
We intend to study 11 adult healthy volunteers on an outpatient basis.
STUDY DESIGN:
All the subjects will first participate in a screening session where the threshold TMS intensity for blocking object discrimination and the optimal coil orientation will be determined using single pulse TMS. Later they will attend the main experiment session where they will be asked to perform the object discrimination task in four blocks, of which the second, third and fourth will be in random order. During the first block, the individual coherence frequency will be determined by recording EEG during the task. During the second, third and fourth blocks, the subjects will receive either unilateral, bilateral or sham rTMS in a random order while EEG is being recorded. Short trains of 7 TMS pulses will be delivered during each trial. TMS pulses will be administered over left and/or right LOG at 80% of threshold intensity blocking object discrimination or 60% maximum stimulator output whichever is smaller.
OUTCOME MEASURES:
We expect that short trains of TMS will affect IHC depending on whether the pulses are synchronous or asynchronous. By modulating IHC, we expect changes in object discrimination task performance. The primary outcome measure in this study includes object discrimination task performance. During the study, we will also compute the individual frequency at which maximum coherence occurs, the threshold intensity and optimal coil direction for blocking object discrimination and the spatio-temporal characteristics of EEG waves during the rTMS trains to confirm that entrainment is occurring.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 - 70 years.
- Able to give his/her own consent to participate in the study.
Key exclusion criteria (11 listed)
- Presence of cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, metal fragments in the eye.
- Pregnancy or lactation.
- History of any serious medical illness or hearing problems
- Intake of medication that affect the central nervous system like anti depressants, antihistamines, antipsychotics, dopamine agonists, benzodiazepines and antiepileptics in the past 3 months.
- Presence of neurological or psychiatric illnesses like brain tumor, migraine, depression, bipolar disorder, schizophrenia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham rTMS | Procedure or surgery | – |
| Bilateral rTMS at same frequency and in phase | Procedure or surgery | – |
| Bilateral rTMS at different frequencies | Procedure or surgery | – |
| Bilateral rTMSat same frequency and out of phase | Procedure or surgery | – |
| rTMS over TP8 | Procedure or surgery | – |
| rTMS over TP7 | Procedure or surgery | – |
Primary outcome
Percentage of correct responses in the midline object recognition task.
Time frame: 4 hours
1 secondary outcome
Threshold intensity for blocking object recognition
Time frame: 4 hours
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 12928837Adler G, Brassen S, Jajcevic A. EEG coherence in Alzheimer's dementia. J Neural Transm (Vienna). 2003 Sep;110(9):1051-8. doi: 10.1007/s00702-003-0024-8.
- Background: PubMed 12102104Gerloff C, Andres FG. Bimanual coordination and interhemispheric interaction. Acta Psychol (Amst). 2002 Jun;110(2-3):161-86. doi: 10.1016/s0001-6918(02)00032-x.
- Background: PubMed 2922407Gray CM, Singer W. Stimulus-specific neuronal oscillations in orientation columns of cat visual cortex. Proc Natl Acad Sci U S A. 1989 Mar;86(5):1698-702. doi: 10.1073/pnas.86.5.1698.
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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?
A study testing Bilateral rTMS at same frequency and in phase, Bilateral rTMS at different frequencies and Bilateral rTMSat same frequency and out of phase in people with Repetitive TMS (rTMS) and Sham rTMS, 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 2 inclusion and 11 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.
What does the primary outcome measure?
Percentage of correct responses in the midline object recognition task. (time frame: 4 hours). 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 NCT01747200, 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.