NCT00063245

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

April 1, 2005

First QC Date

June 23, 2003

Last Update Submit

March 3, 2008

Conditions

Keywords

Motor CortexMoodRewardTranscranial Magnetic StimulationMagnetic CoilHealthy VolunteerHV

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The study is planned for adult subjects with normal neurologic and psychiatric examinations.
  • Healthy male and female volunteers will be included in this protocol.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 10415669BACKGROUND
  • Breiter 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.

    PMID: 9331351BACKGROUND
  • Eaton 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.

    PMID: 1487945BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 23, 2003

First Posted

June 24, 2003

Study Start

June 1, 2003

Study Completion

April 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-04

Locations