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| Tracking Information | |
|---|---|
| First Received Date ICMJE | January 16, 2002 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | January 2002 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00029653 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Effect of Transcranial Magnetic Stimulation on Free Will |
| Official Title ICMJE | The Effect of Transcranial Magnetic Stimulation on Free Will |
| Brief Summary | This study will use transcranial magnetic stimulation (TMS) to investigate how the brain controls movement by sending messages to the spinal cord and muscles. Healthy normal volunteers 21 years of age or older may participate in this study. They must have no medical, neurological or psychiatric illnesses nor have been taking medications that affect nervous system function. Participants will undergo transcranial magnetic stimulation. For this procedure, an insulated wire coil is placed on the scalp or skin. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. If the coil is placed over a nerve or area of the brain that controls muscles, it may cause a muscle twitch, possibly strong enough to move the limb. In other cases, the subject may have a feeling of movement or feel a tingling sensation in a limb. Stimulation over the muscles on the side of the head may cause some discomfort in that area or twitching of the jaw. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The electrical activity of the muscles activated by the stimulation will be recorded using metal electrodes taped to the skin over the muscle. In most cases, the study takes less than 3 hours. |
| Detailed Description | The purpose of this study is to investigate the influence of transcranial magnetic stimulation (TMS) on free will to select movement. There have been debates that most of human voluntary movements are reflexive rather than volitional in nature, although most people feel that their movements are freely chosen. This issue is illuminated by previous TMS studies showing external bias of freely chosen movements by TMS. Recently, we tried to confirm these observations using a more reliable method with subthreshold TMS, but failed. Thus, in this study, we are planning to use suprathreshold TMS to test whether this type of stimulation on different motor areas influences free selection of movements or not. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE | Healthy |
| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 10 |
| Completion Date | June 2002 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Normal adult volunteers who are 21 years or older will be eligible. Volunteers who have either any medico-surgical, neurological and psychiatric illnesses, who have been taking any medication with potential influence on nervous system function, who have a pacemaker, an implanted medical pump, a metal plate or a metal object in the skull or eye (for example, after brain surgery), or who have a history of seizure disorder, will be excluded. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00029653 |
| Responsible Party | |
| Study ID Numbers ICMJE | 020101, 02-N-0101 |
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | June 2002 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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