HealthyNCT00063245
Stimulating Deep Brain Regions With a Magnetic Stimulator
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a special coil designed for magnetic stimulation of areas deep in the brain can affect mood and emotion in healthy volunteers. Researchers hope to better understand how the brain controls mood and motivation and what goes wrong with this process in disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Apr 2005
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The study is planned for adult subjects with normal neurologic and psychiatric examinations.
- Healthy male and female volunteers will be included in this protocol.
Who cannot join
- History of surgery with metallic implants or known history of metallic particles in the eye, cardiac pacemaker, neurostimulators, cochlear implants, history of drug abuse, psychiatric illness, hypertension, or concurrent medication.
- Children are also excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Noninvasive Stimulation of Human Deep Brain Regions With a Magnetic Stimulator
The purpose of this study is to determine whether a special coil designed for magnetic stimulation of areas deep in the brain can affect mood and emotion in healthy volunteers. Researchers hope to better understand how the brain controls mood and motivation and what goes wrong with this process in disease.
For transcranial magnetic stimulation (TMS), a wire coil is held over the scalp. A brief electrical current passes through the coil and creates a magnetic pulse that stimulates the brain.
Read more
Eighteen participants, 9 men and 9 women, will be enrolled in this study. They will be assigned to one or both of the following two experiments.
Experiment 1
In this experiment, researchers will test the effectiveness of a new type of wire coil. They will deliver magnetic impulses of varying strength. Approximately 150 stimulations will be given over of about 20 minutes. To determine whether the coil causes any problem with hearing, participants will undergo a hearing test immediately before and after the experiment.
Experiment 2
This experiment, which has two parts, is designed to determine whether TMS can affect mood. In the first part, participants will be asked to report any changes in mood before, during and after the magnetic stimulation. In the second part, they will be asked to choose between sets of 2 identical pictures-choosing one will result in full magnetic stimulation, choosing the other will result in stimulation at 10 percent of full intensity.
Participants will be compensated up to $100 for their involvement in this study.
Read the detailed description
Current magnetic stimulation techniques permit only superficial stimulation of brain, but for some purposes deeper stimulation would be helpful. The purpose of this study is to determine whether a special coil designed for magnetic stimulation of deep brain regions can affect mood and emotion in healthy human volunteers. The special coil was designed to stimulate neuronal pathways related to the control of motivation and reward, specifically, fibers connecting the cingulated or prefrontal cortex with the nucleus accumbens. Computerized theoretical calculations were made in order to optimize the coil design for maximizing the percentage of stimulation in depth relative to the cortical regions. The present study will look first at the influence of the coil on the response from motor cortex. Should there be good evidence the coil can truly be more effective in stimulating deep structures, then we will explore whether it can indeed affect mood and emotion when single pulses are applied.
- Conditions
- Healthy
- Keywords
- Motor Cortex, Mood, Reward, Transcranial Magnetic Stimulation, Magnetic Coil, 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 posted24 Jun 2003 (estimated)
- Study startJun 2003
- Study completionApr 2005
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.
- 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
- 18 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063245
- Sponsor's protocol ID
- 030231
- Other IDs
- 03-N-0231
- Status last verified
- Apr 2005
- First submitted
- 23 Jun 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Breiter HC, Rosen BR. Functional magnetic resonance imaging of brain reward circuitry in the human. Ann N Y Acad Sci. 1999 Jun 29;877:523-47. doi: 10.1111/j.1749-6632.1999.tb09287.x.
PubMed 10415669Breiter HC, Gollub RL, Weisskoff RM, Kennedy DN, Makris N, Berke JD, Goodman JM, Kantor HL, Gastfriend DR, Riorden JP, Mathew RT, Rosen BR, Hyman SE. Acute effects of cocaine on human brain activity and emotion. Neuron. 1997 Sep;19(3):591-611. doi: 10.1016/s0896-6273(00)80374-8.
PubMed 9331351Eaton H. Electric field induced in a spherical volume conductor from arbitrary coils: application to magnetic stimulation and MEG. Med Biol Eng Comput. 1992 Jul;30(4):433-40. doi: 10.1007/BF02446182.
PubMed 1487945
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Stimulation of Human Deep Brain Regions With a Magnetic Stimulator
- ClinicalTrials.gov ID
- NCT00063245
- Acronym / sponsor ID
- 030231
- Conditions
- Healthy
- Keywords
- Motor Cortex, Mood, Reward, Transcranial Magnetic Stimulation, Magnetic Coil, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jun 2003
- Study completion
- Apr 2005
- First posted
- 24 Jun 2003 (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.
The purpose of this study is to determine whether a special coil designed for magnetic stimulation of areas deep in the brain can affect mood and emotion in healthy volunteers. Researchers hope to better understand how the brain controls mood and motivation and what goes wrong with this process in disease.
For transcranial magnetic stimulation (TMS), a wire coil is held over the scalp. A brief electrical current passes through the coil and creates a magnetic pulse that stimulates the brain.
Eighteen participants, 9 men and 9 women, will be enrolled in this study. They will be assigned to one or both of the following two experiments.
Experiment 1
In this experiment, researchers will test the effectiveness of a new type of wire coil. They will deliver magnetic impulses of varying strength. Approximately 150 stimulations will be given over of about 20 minutes. To determine whether the coil causes any problem with hearing, participants will undergo a hearing test immediately before and after the experiment.
Experiment 2
This experiment, which has two parts, is designed to determine whether TMS can affect mood. In the first part, participants will be asked to report any changes in mood before, during and after the magnetic stimulation. In the second part, they will be asked to choose between sets of 2 identical pictures-choosing one will result in full magnetic stimulation, choosing the other will result in stimulation at 10 percent of full intensity.
Participants will be compensated up to $100 for their involvement in this study.
Detailed description
Current magnetic stimulation techniques permit only superficial stimulation of brain, but for some purposes deeper stimulation would be helpful. The purpose of this study is to determine whether a special coil designed for magnetic stimulation of deep brain regions can affect mood and emotion in healthy human volunteers. The special coil was designed to stimulate neuronal pathways related to the control of motivation and reward, specifically, fibers connecting the cingulated or prefrontal cortex with the nucleus accumbens. Computerized theoretical calculations were made in order to optimize the coil design for maximizing the percentage of stimulation in depth relative to the cortical regions. The present study will look first at the influence of the coil on the response from motor cortex. Should there be good evidence the coil can truly be more effective in stimulating deep structures, then we will explore whether it can indeed affect mood and emotion when single pulses are applied.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The study is planned for adult subjects with normal neurologic and psychiatric examinations.
- Healthy male and female volunteers will be included in this protocol.
Key exclusion criteria (2 listed)
- History of surgery with metallic implants or known history of metallic particles in the eye, cardiac pacemaker, neurostimulators, cochlear implants, history of drug abuse, psychiatric illness, hypertension, or concurrent medication.
- Children are also excluded.
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 4 Mar 2008.
- Background: PubMed 10415669Breiter HC, Rosen BR. Functional magnetic resonance imaging of brain reward circuitry in the human. Ann N Y Acad Sci. 1999 Jun 29;877:523-47. doi: 10.1111/j.1749-6632.1999.tb09287.x.
- Background: PubMed 9331351Breiter HC, Gollub RL, Weisskoff RM, Kennedy DN, Makris N, Berke JD, Goodman JM, Kantor HL, Gastfriend DR, Riorden JP, Mathew RT, Rosen BR, Hyman SE. Acute effects of cocaine on human brain activity and emotion. Neuron. 1997 Sep;19(3):591-611. doi: 10.1016/s0896-6273(00)80374-8.
- Background: PubMed 1487945Eaton H. Electric field induced in a spherical volume conductor from arbitrary coils: application to magnetic stimulation and MEG. Med Biol Eng Comput. 1992 Jul;30(4):433-40. doi: 10.1007/BF02446182.
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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 2 inclusion and 2 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 4 Mar 2008. 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 NCT00063245, 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 4 Mar 2008.