Stimulating Deep Brain Regions With a Magnetic Stimulator
|First Received Date ICMJE||June 23, 2003|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||June 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00063245 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Stimulating Deep Brain Regions With a Magnetic Stimulator|
|Official Title ICMJE||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.
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.
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.
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 Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||April 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
The study is planned for adult subjects with normal neurologic and psychiatric examinations.
Healthy male and female volunteers will be included in this protocol.
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.
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00063245|
|Other Study ID Numbers ICMJE||030231, 03-N-0231|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP