Epilepsy, Temporal LobeNCT00001672
Language Localization Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Epilepsy
An observational study of Epilepsy, Temporal Lobe, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) may be able to provide a moderately detailed localization of language functions in the brain. We propose to test the ability of rTMS to locate the substrate of visual naming to a limited area of the temporal lobe in patients with temporal lobe epilepsy before and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy, Temporal Lobe
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1997to Mar 2000
- 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
- No healthy volunteers
- Child, Adult, Older adult
Patients will be drawn from among those referred to the NINDS Epilepsy Research Branch.
No patients with evidence for a progressive neurological disorder.
No subjects with metal hardware in the cranial cavity, cardiac pacemakers, indwelling medication pumps, cochlear implants, intracardiac lines, significant intracranial masses or evidence of increased intracranial pressure.
Women must not be pregnant.
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
Repetitive transcranial magnetic stimulation (rTMS) may be able to provide a moderately detailed localization of language functions in the brain. We propose to test the ability of rTMS to locate the substrate of visual naming to a limited area of the temporal lobe in patients with temporal lobe epilepsy before and after surgical resections. The study is expected to yield information on the organization of language in the temporal lobes and how unilateral temporal lobe lesions and lobectomy cause relocation of language mechanisms in the lesioned and in the other hemisphere. It will also be a preliminary step in the development of a clinically useful procedure for locating critical language areas in potential surgical candidates.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) may be able to provide a moderately detailed localization of language functions in the brain. We propose to test the ability of rTMS to locate the substrate of visual naming to a limited area of the temporal lobe in patients with temporal lobe epilepsy before and after surgical resections. The study is expected to yield information on the organization of language in the temporal lobes and how unilateral temporal lobe lesions and lobectomy cause relocation of language mechanisms in the lesioned and in the other hemisphere. It will also be a preliminary step in the development of a clinically useful procedure for locating critical language areas in potential surgical candidates.
- Conditions
- Epilepsy, Temporal Lobe
- Keywords
- Brain Mapping, Cognition, Noninvasive, Temporal Lobe, Visual Naming
- Medical subject headings
- Epilepsy, Temporal Lobe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startSep 1997
- Study completionMar 2000
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 Epilepsy, Temporal LobeStudies 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
- 40 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
- NCT00001672
- Sponsor's protocol ID
- 970175
- Other IDs
- 97-N-0175
- Status last verified
- Aug 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Claus D, Weis M, Treig T, Lang C, Eichhorn KF, Sembach O. Influence of repetitive magnetic stimuli on verbal comprehension. J Neurol. 1993;240(3):149-50. doi: 10.1007/BF00857519.
PubMed 8482986Desmond JE, Sum JM, Wagner AD, Demb JB, Shear PK, Glover GH, Gabrieli JD, Morrell MJ. Functional MRI measurement of language lateralization in Wada-tested patients. Brain. 1995 Dec;118 ( Pt 6):1411-9. doi: 10.1093/brain/118.6.1411.
PubMed 8595473Epstein CM, Lah JJ, Meador K, Weissman JD, Gaitan LE, Dihenia B. Optimum stimulus parameters for lateralized suppression of speech with magnetic brain stimulation. Neurology. 1996 Dec;47(6):1590-3. doi: 10.1212/wnl.47.6.1590.
PubMed 8960755
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
- Language Localization Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT00001672
- Acronym / sponsor ID
- 970175
- Conditions
- Epilepsy, Temporal Lobe
- Keywords
- Brain Mapping, Cognition, Noninvasive, Temporal Lobe, Visual Naming
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Sep 1997
- Study completion
- Mar 2000
- First posted
- 10 Dec 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.
Repetitive transcranial magnetic stimulation (rTMS) may be able to provide a moderately detailed localization of language functions in the brain. We propose to test the ability of rTMS to locate the substrate of visual naming to a limited area of the temporal lobe in patients with temporal lobe epilepsy before and after surgical resections. The study is expected to yield information on the organization of language in the temporal lobes and how unilateral temporal lobe lesions and lobectomy cause relocation of language mechanisms in the lesioned and in the other hemisphere. It will also be a preliminary step in the development of a clinically useful procedure for locating critical language areas in potential surgical candidates.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) may be able to provide a moderately detailed localization of language functions in the brain. We propose to test the ability of rTMS to locate the substrate of visual naming to a limited area of the temporal lobe in patients with temporal lobe epilepsy before and after surgical resections. The study is expected to yield information on the organization of language in the temporal lobes and how unilateral temporal lobe lesions and lobectomy cause relocation of language mechanisms in the lesioned and in the other hemisphere. It will also be a preliminary step in the development of a clinically useful procedure for locating critical language areas in potential surgical candidates.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not 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 8482986Claus D, Weis M, Treig T, Lang C, Eichhorn KF, Sembach O. Influence of repetitive magnetic stimuli on verbal comprehension. J Neurol. 1993;240(3):149-50. doi: 10.1007/BF00857519.
- Background: PubMed 8595473Desmond JE, Sum JM, Wagner AD, Demb JB, Shear PK, Glover GH, Gabrieli JD, Morrell MJ. Functional MRI measurement of language lateralization in Wada-tested patients. Brain. 1995 Dec;118 ( Pt 6):1411-9. doi: 10.1093/brain/118.6.1411.
- Background: PubMed 8960755Epstein CM, Lah JJ, Meador K, Weissman JD, Gaitan LE, Dihenia B. Optimum stimulus parameters for lateralized suppression of speech with magnetic brain stimulation. Neurology. 1996 Dec;47(6):1590-3. doi: 10.1212/wnl.47.6.1590.
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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 Epilepsy, Temporal Lobe, 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 NCT00001672, 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.