HealthyNCT00051870
Brain Encoding for Memory
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This two-part study will use transcranial magnetic stimulation, or TMS (see below), to explore how the brain forms memories. People remember only some of the events they experience every day, such as faces they perceive, words they read, speech they hear and interpret, and so forth. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Magstim Rapid Magnetic Stimulator
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jan 2005
- 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
Who may be able to join
- Healthy right handed volunteers, aged 18-35 years, will be included in this protocol.
Who cannot join
- Exclusion criteria for this study will be any current medical or surgical condition or psychiatric or neurological illness. Furthermore, any individual who is on medication with potential influence on nervous system function, who has a history of surgery with metallic implants or known history of metallic particles in the eye, cardiac pacemaker, neural stimulators, cochlear implants, pregnancy, or history of drug abuse, will be excluded from the study.
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: Role of the Prefrontal Cortex in Successful Memory Encoding
This two-part study will use transcranial magnetic stimulation, or TMS (see below), to explore how the brain forms memories. People remember only some of the events they experience every day, such as faces they perceive, words they read, speech they hear and interpret, and so forth. The events remembered are those that have been saved or formed in the brain. Part 1 of this study involves testing materials for Part 2, the TMS experiment. Part 2 uses TMS to examine what parts of the brain are involved in forming memories. Information gained from this study may be used in developing methods of enhancing memory in both healthy people and in patients with memory impairments.
Healthy right-handed volunteers between 18 and 35 years of age may be eligible for this study. Candidates may be screened with a medical interview and physical examination and a brief test of short- and long-term visual and verbal memory. Eligible volunteers may participate in Part 1 or Part 2 of the study, as follows:
Read more
Part 1 - Preparation of Words and Picture Materials
Participants look at several words or shapes that appear in random order on a computer screen and try to remember them as well as possible for a memory test that will be given 20 minutes later. Each image appears on the screen for 3/4 of a second, with 1-1/4-second intervals between them. For the test, words and shapes are again shown on the computer screen at the same timing and intervals. When the items appear, the subject presses one of three buttons as quickly as possible, determining if he or she has recognized the items with a high or low level of confidence. The entire procedure lasts up to 1 hour, with breaks in between. The purpose of this experiment is to find appropriate words and pictures to use as stimuli in the TMS study described below.
Part 2 - TMS Experiment
For TMS, the subject sits in a comfortable chair. An insulated wire coil is placed on the scalp, and brief electrical currents are passed through the coil, creating magnetic pulses that stimulate the brain. The pulses may cause a pulling sensation on the skin under the coil and twitching in muscles of the arm or leg. Electrodes are taped to the skin over some muscles of the hands to record the electrical activity of the muscles. Pulses are delivered in trains or short bursts of impulses, each lasting half a second. Participants receive 90 trains for a total of 900 pulses. TMS is applied during the first part of the memory study, when the words and shapes are first presented on the computer screen, but not during the second presentation for memory testing. The entire procedure takes up to 2 hours, with breaks in between.
Before the TMS session, participants undergo magnetic resonance imaging (MRI) to determine where to place the coil for TMS. For MRI, the subject lies still for up to 30 minutes at a time on a table that slides into the scanner, a narrow metal cylinder surrounded by a strong magnetic field. Earplugs are worn to muffle loud knocking sounds that occur while the scanner takes pictures. Subjects can communicate with the MRI staff at all times and can ask to stop the procedure at any time.
Read the detailed description
Recent functional imaging studies showed that memory retrieval is associated with activation in the prefrontal cortex during the encoding process. However, a cause-effect link between prefrontal activity and encoding has not been demonstrated. The purpose of this protocol is to test the hypothesis that inhibitory repetitive transcranial magnetic stimulation (rTMS) over left prefrontal cortex interferes with encoding of verbal items (words) into episodic memory, thereby identifying this region as a substrate mediating verbal encoding. Identification of the role of the prefrontal cortex in verbal memory encoding is the first step to try to develop strategies to enhance such encoding processes in patients with memory impairments, an issue of relevance in neurorehabilitation.
We plan to apply rTMS over left prefrontal cortex and over two control sites, during encoding of verbal and nonverbal items into episodic memory. Normal, healthy volunteers will be studied. The outcome measure will be performance on a subsequent memory test for words presented during left prefrontal rTMS, as compared to performance for words presented during rTMS over the control sites or without rTMS. This measure will indicate if left prefrontal stimulation can disrupt memory encoding of words relative to other stimulation sites or to no stimulation.
A secondary outcome measure will be performance on a subsequent memory test for words presented during left prefrontal rTMS, as compared to performance for pictures presented during left prefrontal rTMS. This measure will indicate if disruption of left prefrontal function with TMS affects verbal and more than non-verbal memory encoding.
- Conditions
- Healthy
- Being tested
- Magstim Rapid Magnetic Stimulator
- Keywords
- Verbal Memory, Inhibition, Transcranial Magnetic Stimulation, Cortical Excitability, Nonverbal Memory
- Medical subject headings
- Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magstim Rapid Magnetic StimulatorDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2003 (estimated)
- Study startJan 2003
- Study completionJan 2005
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.
- 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
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051870
- Sponsor's protocol ID
- 030081
- Other IDs
- 03-N-0081
- Status last verified
- Jan 2005
- First submitted
- 16 Jan 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Squire LR, Knowlton B, Musen G. The structure and organization of memory. Annu Rev Psychol. 1993;44:453-95. doi: 10.1146/annurev.ps.44.020193.002321. No abstract available.
PubMed 8434894Tulving E, Markowitsch HJ, Craik FE, Habib R, Houle S. Novelty and familiarity activations in PET studies of memory encoding and retrieval. Cereb Cortex. 1996 Jan-Feb;6(1):71-9. doi: 10.1093/cercor/6.1.71.
PubMed 8670640Kapur S, Tulving E, Cabeza R, McIntosh AR, Houle S, Craik FI. The neural correlates of intentional learning of verbal materials: a PET study in humans. Brain Res Cogn Brain Res. 1996 Nov;4(4):243-9. doi: 10.1016/s0926-6410(96)00058-4.
PubMed 8957565
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
- Role of the Prefrontal Cortex in Successful Memory Encoding
- ClinicalTrials.gov ID
- NCT00051870
- Acronym / sponsor ID
- 030081
- Conditions
- Healthy
- Keywords
- Verbal Memory, Inhibition, Transcranial Magnetic Stimulation, Cortical Excitability, Nonverbal Memory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jan 2003
- Study completion
- Jan 2005
- First posted
- 17 Jan 2003 (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 two-part study will use transcranial magnetic stimulation, or TMS (see below), to explore how the brain forms memories. People remember only some of the events they experience every day, such as faces they perceive, words they read, speech they hear and interpret, and so forth. The events remembered are those that have been saved or formed in the brain. Part 1 of this study involves testing materials for Part 2, the TMS experiment. Part 2 uses TMS to examine what parts of the brain are involved in forming memories. Information gained from this study may be used in developing methods of enhancing memory in both healthy people and in patients with memory impairments.
Healthy right-handed volunteers between 18 and 35 years of age may be eligible for this study. Candidates may be screened with a medical interview and physical examination and a brief test of short- and long-term visual and verbal memory. Eligible volunteers may participate in Part 1 or Part 2 of the study, as follows:
Part 1 - Preparation of Words and Picture Materials
Participants look at several words or shapes that appear in random order on a computer screen and try to remember them as well as possible for a memory test that will be given 20 minutes later. Each image appears on the screen for 3/4 of a second, with 1-1/4-second intervals between them. For the test, words and shapes are again shown on the computer screen at the same timing and intervals. When the items appear, the subject presses one of three buttons as quickly as possible, determining if he or she has recognized the items with a high or low level of confidence. The entire procedure lasts up to 1 hour, with breaks in between. The purpose of this experiment is to find appropriate words and pictures to use as stimuli in the TMS study described below.
Part 2 - TMS Experiment
For TMS, the subject sits in a comfortable chair. An insulated wire coil is placed on the scalp, and brief electrical currents are passed through the coil, creating magnetic pulses that stimulate the brain. The pulses may cause a pulling sensation on the skin under the coil and twitching in muscles of the arm or leg. Electrodes are taped to the skin over some muscles of the hands to record the electrical activity of the muscles. Pulses are delivered in trains or short bursts of impulses, each lasting half a second. Participants receive 90 trains for a total of 900 pulses. TMS is applied during the first part of the memory study, when the words and shapes are first presented on the computer screen, but not during the second presentation for memory testing. The entire procedure takes up to 2 hours, with breaks in between.
Before the TMS session, participants undergo magnetic resonance imaging (MRI) to determine where to place the coil for TMS. For MRI, the subject lies still for up to 30 minutes at a time on a table that slides into the scanner, a narrow metal cylinder surrounded by a strong magnetic field. Earplugs are worn to muffle loud knocking sounds that occur while the scanner takes pictures. Subjects can communicate with the MRI staff at all times and can ask to stop the procedure at any time.
Detailed description
Recent functional imaging studies showed that memory retrieval is associated with activation in the prefrontal cortex during the encoding process. However, a cause-effect link between prefrontal activity and encoding has not been demonstrated. The purpose of this protocol is to test the hypothesis that inhibitory repetitive transcranial magnetic stimulation (rTMS) over left prefrontal cortex interferes with encoding of verbal items (words) into episodic memory, thereby identifying this region as a substrate mediating verbal encoding. Identification of the role of the prefrontal cortex in verbal memory encoding is the first step to try to develop strategies to enhance such encoding processes in patients with memory impairments, an issue of relevance in neurorehabilitation.
We plan to apply rTMS over left prefrontal cortex and over two control sites, during encoding of verbal and nonverbal items into episodic memory. Normal, healthy volunteers will be studied. The outcome measure will be performance on a subsequent memory test for words presented during left prefrontal rTMS, as compared to performance for words presented during rTMS over the control sites or without rTMS. This measure will indicate if left prefrontal stimulation can disrupt memory encoding of words relative to other stimulation sites or to no stimulation.
A secondary outcome measure will be performance on a subsequent memory test for words presented during left prefrontal rTMS, as compared to performance for pictures presented during left prefrontal rTMS. This measure will indicate if disruption of left prefrontal function with TMS affects verbal and more than non-verbal memory encoding.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy right handed volunteers, aged 18-35 years, will be included in this protocol.
Key exclusion criteria (1 listed)
- Exclusion criteria for this study will be any current medical or surgical condition or psychiatric or neurological illness. Furthermore, any individual who is on medication with potential influence on nervous system function, who has a history of surgery with metallic implants or known history of metallic particles in the eye, cardiac pacemaker, neural stimulators, cochlear implants, pregnancy, or history of drug abuse, will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magstim Rapid Magnetic Stimulator | Device | – |
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 8434894Squire LR, Knowlton B, Musen G. The structure and organization of memory. Annu Rev Psychol. 1993;44:453-95. doi: 10.1146/annurev.ps.44.020193.002321. No abstract available.
- Background: PubMed 8670640Tulving E, Markowitsch HJ, Craik FE, Habib R, Houle S. Novelty and familiarity activations in PET studies of memory encoding and retrieval. Cereb Cortex. 1996 Jan-Feb;6(1):71-9. doi: 10.1093/cercor/6.1.71.
- Background: PubMed 8957565Kapur S, Tulving E, Cabeza R, McIntosh AR, Houle S, Craik FI. The neural correlates of intentional learning of verbal materials: a PET study in humans. Brain Res Cogn Brain Res. 1996 Nov;4(4):243-9. doi: 10.1016/s0926-6410(96)00058-4.
Related trials for Healthy
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Enrolling by invitationObservational study
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
Healthy Donors
RecruitingObservational study
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Immunosuppression, Periodontal Disease
RecruitingObservational study
Adaptive Optics Retinal Imaging
Eye Diseases, Healthy Volunteers
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
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.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
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 NCT00051870, 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; AzTrials last refreshed its copy on 27 Oct 2026.