Healthy Clinical Trial
Official title:
10 Hz rTMS to Subject Specific Regions of Cerebral Cortex Improves Memory in Healthy Subjects
This study will examine the effect of transcranial magnetic stimulation (TMS) on short-term
memory in healthy adults. Healthy people use their brains to answer short-term memory
questions in a different way than do patients with schizophrenia. Attention and memory
deficits in schizophrenia patients significantly hamper their recovery and rehabilitation,
yet there are no effective treatments for these impairments. TMS is a method of brain
stimulation that may be able to change the electrical activity of the nerve cells of the
brain and improve certain brain functions. This study will explore the effect of TMS on
memory and perhaps discover brain processes that may be helpful in developing new ways to
treat schizophrenia.
Healthy volunteers between 18 and 55 years of age, excluding pregnant women, may be eligible
for this study. Participants undergo the following tests and procedures:
- Medical history, physical examination, blood tests, electrocardiogram (EKG), and urine
pregnancy test for women of childbearing age.
- Magnetic resonance imaging (MRI) and functional MRI (fMRI). These tests are done in
participants who have not had structural and functional MRIs as participants in NIMH's
2-day schizophrenia study within 90 days of entering the current study. MRI is done to
locate the place in the brain to simulate with TMS and fMRI is done to look at brain
activity while the subject solves short-term memory tasks. Both tests are done at the
same session. Before the scan, four vitamin E capsules are taped to the subject's
scalp. After the capsules are in place, the subject lies on a stretcher that is moved
into the scanner - a narrow cylinder with a strong magnetic field. During the scan,
subjects are asked to do some simple tests, such as watching pictures on a screen or
pressing buttons in response to numbers they were shown a few seconds earlier. Scanning
may take up to 2 hours, but usually lasts between 45 and 90 minutes.
- TMS. For this procedure, subjects receive either active TMS or a sham procedure
(placebo) that imitates TMS but does not use real electrical stimulation. For TMS, an
insulated wire coil is placed on the scalp and a brief electrical current is passed
through it. This generates magnetic pulses that travel through the scalp and skull and
cause small electrical currents in the cortex, or outer part of the brain. The
stimulation may cause muscle twitching in the scalp or face and may also cause small
movement of the limbs. During the procedure, electrodes are taped to the scalp to
record the electrical activity of the brain while short-term memory is tested. Two
tests make up a set. There are a total of six test sets; each set takes about 3
minutes. Five periods of electrical stimulation are delivered before each test set.
Each period of stimulation lasts 5 seconds, followed by a 10-second rest period. The
stimulation-rest intervals continue until five periods of TMS have been applied. For
the memory test, subjects press a key on a computer keyboard as quickly and accurately
as possible in a test of their ability to remember a string of numbers, or letters.
- Questionnaires. At the beginning and end of the TMS session, participants fill out
questionnaires that assess their mood, ability to concentrate, and level of anxiety.
Status | Completed |
Enrollment | 80 |
Est. completion date | February 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA: 1. Male and Female subjects, age 18-55 EXCLUSION CRITERIA: 1. Significant psychiatric, or severe chronic medical illness at the time of the study, or by history. This criterion includes the absence of substance abuse histories, learning disabilities or any other DSM-IV AXIS I or II disorder with documented cognitive impairment. The P.I. or his designate will evaluate medical histories. Medical conditions that are judged not to interfere with the study may be allowed. 2. Pregnancy, personal or family history of epilepsy, concurrent use of tricyclic antidepressants, neuroleptic agents, or any licit or illicit drugs that could lower the seizure threshold, or history of complicated migraine. 3. Persons with surgically or traumatically implanted ferro-magnetic objects in the head that may pose a physical hazard during magnetic stimulation will also be excluded. 4. Use of psychotropic substances in the last 3 months. 5. Head injury with a period of more than 15 minutes unconsciousness, or head trauma with any duration loss of consciousness in the last year, or any evidence of functional impairment due to and persisting after head trauma. 6. Use of caffeine or tobacco in the 2 hours preceding the test. 7. Subjects who have been previously excluded from NIH MRI or TMS protocols for safety reasons. 8. Subjects who are found to have eye lesions on exam. 9. First degree relative with a history of cognitive disorder with onset before age 55 by subject report, and by collateral report of at least one other family member, if necessary. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Mental Health (NIMH) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
Docherty NM, Hawkins KA, Hoffman RE, Quinlan DM, Rakfeldt J, Sledge WH. Working memory, attention, and communication disturbances in schizophrenia. J Abnorm Psychol. 1996 May;105(2):212-9. — View Citation
McGurk SR, Moriarty PJ, Harvey PD, Parrella M, White L, Davis KL. The longitudinal relationship of clinical symptoms, cognitive functioning, and adaptive life in geriatric schizophrenia. Schizophr Res. 2000 Mar 16;42(1):47-55. — View Citation
McGurk SR, Mueser KT. Cognitive functioning and employment in severe mental illness. J Nerv Ment Dis. 2003 Dec;191(12):789-98. — View Citation
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