HealthyNCT00029653
Effect of Transcranial Magnetic Stimulation on Free Will
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 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Jun 2002
- 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
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.
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: The Effect of Transcranial Magnetic Stimulation on Free Will
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.
Read more
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.
Read the 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.
- Conditions
- Healthy
- Keywords
- Frontal Lobe, Reaction Time, Movement Preparation, Motor Threshold, Transcranial Magnetic Stimulation, Motor Cortex, Healthy Volunteer, Normal Control, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2002 (estimated)
- Study startJan 2002
- Study completionJun 2002
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
- 10 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029653
- Sponsor's protocol ID
- 020101
- Other IDs
- 02-N-0101
- Status last verified
- Jun 2002
- First submitted
- 16 Jan 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Prochazka A, Clarac F, Loeb GE, Rothwell JC, Wolpaw JR. What do reflex and voluntary mean? Modern views on an ancient debate. Exp Brain Res. 2000 Feb;130(4):417-32. doi: 10.1007/s002219900250.
PubMed 10717785Ammon K, Gandevia SC. Transcranial magnetic stimulation can influence the selection of motor programmes. J Neurol Neurosurg Psychiatry. 1990 Aug;53(8):705-7. doi: 10.1136/jnnp.53.8.705.
PubMed 2213050Brasil-Neto JP, Pascual-Leone A, Valls-Sole J, Cohen LG, Hallett M. Focal transcranial magnetic stimulation and response bias in a forced-choice task. J Neurol Neurosurg Psychiatry. 1992 Oct;55(10):964-6. doi: 10.1136/jnnp.55.10.964.
PubMed 1431962
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
- The Effect of Transcranial Magnetic Stimulation on Free Will
- ClinicalTrials.gov ID
- NCT00029653
- Acronym / sponsor ID
- 020101
- Conditions
- Healthy
- Keywords
- Frontal Lobe, Reaction Time, Movement Preparation, Motor Threshold, Transcranial Magnetic Stimulation, Motor Cortex, Healthy Volunteer, Normal Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jan 2002
- Study completion
- Jun 2002
- First posted
- 17 Jan 2002 (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 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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 10717785Prochazka A, Clarac F, Loeb GE, Rothwell JC, Wolpaw JR. What do reflex and voluntary mean? Modern views on an ancient debate. Exp Brain Res. 2000 Feb;130(4):417-32. doi: 10.1007/s002219900250.
- Background: PubMed 2213050Ammon K, Gandevia SC. Transcranial magnetic stimulation can influence the selection of motor programmes. J Neurol Neurosurg Psychiatry. 1990 Aug;53(8):705-7. doi: 10.1136/jnnp.53.8.705.
- Background: PubMed 1431962Brasil-Neto JP, Pascual-Leone A, Valls-Sole J, Cohen LG, Hallett M. Focal transcranial magnetic stimulation and response bias in a forced-choice task. J Neurol Neurosurg Psychiatry. 1992 Oct;55(10):964-6. doi: 10.1136/jnnp.55.10.964.
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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.
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 NCT00029653, 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.