EpilepsyPhase 2NCT00048490
Transcranial Magnetic Stimulation to Treat Epilepsy
A Phase 2 study testing transcranial magnetic stimulation (TMS) in people with Epilepsy, 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, or TMS (described below), to treat epilepsy in certain patients whose seizures persist despite optimum medical treatment. TMS used in this study is intended to lessen the number of seizures a patient has by decreasing excitability of the brain in the region where… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy
- What is being tested?
- transcranial magnetic stimulation (TMS)
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Oct 2004
- Phase
- Phase 2
- 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
Who may be able to join
- Patients will be selected from the ERB, NINDS, NIH Epilepsy Clinic.
- Age 5 to 65 at entry to protocol.
- History of localization-related epilepsy for two or more years.
- Patients are on a stable anti-convulsant regimen defined as unchanged medicines and dose modifications lower than 20% in the last month. Blood levels of anticonvulsants will be measured at the beginning of the study, prior to stimulation and after the study to assure that the type and dose of medication will remain constant.
- Seizures are not completely responsive to medical treatment (1 or more seizures per week for at least 6 months) and patients have continued seizures despite best medical treatment in the past.
- The patients have a localized neocortical seizure focus, based on EEG and neuroimaging findings.
Who cannot join
- Patients will be excluded from this study if they:
- are pregnant women (tested with urine pregnancy test). The effects of rTMS on pregnancy are unknown.
- have severe coronary disease.
- have increased intracranial pressure as expressed by the presence of papilledema.
- have cardiac pacemakers.
- take neuroleptic or antidepressant medications.
- progressive neurologic disease.
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: Drug-Refractory Neocortical Epilepsy: rTMS Treatment
This study will use transcranial magnetic stimulation, or TMS (described below), to treat epilepsy in certain patients whose seizures persist despite optimum medical treatment. TMS used in this study is intended to lessen the number of seizures a patient has by decreasing excitability of the brain in the region where the seizures originate.
Patients between 5 and 65 years of age who have had epilepsy for two or more years and have had at least one seizure a week for at least 6 months may be eligible for this 18-week study. Their seizures must come from a neocortical focus-that is, near the surface of the brain. Candidates will be selected from the NIH Epilepsy clinic and will be screened with an electroencephalogram (EEG), magnetic resonance imaging (MRI) scans, and blood tests.
Read more
Participants will keep a diary of the seizures they experience over an 8-week period. After the 8 weeks, they will come to the NIH outpatient clinic for 6 consecutive days for the following procedures:
- Day 1: A regular clinic visit, plus 6 hours of video-EEG recording (described below)
- Days 2 through 5: Video-EEG monitoring and TMS as follows:
8:00 - 11: 00 a.m. 3 hours video-EEG monitoring
11:00 - 12:30 p.m. TMS (includes set-up time; actual stimulation time lasts 30 minutes)
12:30 - 3:00 p.m. Lunch + rest
3:00 - 4:30 p.m. TMS
4:30 - 7:30 p.m. 3 hours video-EEG monitoring
(On the fifth day, subjects will have 6 hours of video-EEG monitoring in the afternoon instead of 3 hours.)
Participants will be randomly assigned to one of two TMS groups. One group will have TMS delivered in a way that is thought to have a chance of reducing seizures; the other will have sham, or placebo, stimulation.
When the TMS sessions are completed, participants will keep a diary of their seizures for another 8 weeks.
Transcranial Magnetic Stimulation
For TMS, an insulated wire coil is placed on the subject's scalp. A brief electrical current passes through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the cortex, or outer part of the brain. The stimulation may cause muscle, hand or arm twitching, or may cause twitches or temporary tingling in the forearm, head, or face muscles. During the stimulation, electrical activity of muscles is recorded with a computer or other recording device, using electrodes attached to the skin with tape. Some TMS sessions may be videotaped.
Video-EEG Recordings
The EEG recording device is housed in a small pouchlike container that is worn below the shoulder, attached to a belt worn around the waist.
Read the detailed description
In this study, we will use repetitive transcranial magnetic stimulation (rTMS) at 1.0 Hz to treat patients with poorly controlled neocortical epilepsy refractory to pharmacological treatments as a continuation of our previous study (1.0 Hz TMS in 24 patients with refractory partial epilepsy). Previously, we observed that 1.0 Hz rTMS reduced seizure frequency during the first 2 weeks after TMS, although the difference did not reach statistical significance. However, the results suggested that patients with neocortical temporal foci would have a better response than those with mesial temporal foci. We wish to see whether rTMS leads to a significant reduction in seizure frequency in neocortical epilepsy considering the depth of magnetic field. The design will include two parallel groups, one receiving active treatment, and one sham stimulation directed away from the epileptic focus. The patients and the rating physicians will be blinded to the treatment. 1.0 Hz TMS is a rate proven to induce long term depression in animal models and reported to decrease the excitability of both human and animal cerebral cortex. Our preliminary controlled study showed a trend for reduced seizure frequency after 1.0 Hz stimulation. The main outcome measure will be a reduction in seizure frequency over two weeks after stimulation.
- Conditions
- Epilepsy
- Being tested
- transcranial magnetic stimulation (TMS)
- Keywords
- Seizures, Magnetism, Brain, Stimulation, Therapy, Epilepsy
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulation (TMS)Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2002 (estimated)
- Study startOct 2002
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 70 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048490
- Sponsor's protocol ID
- 030024
- Other IDs
- 03-N-0024
- Status last verified
- Oct 2004
- First submitted
- 31 Oct 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
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
- Drug-Refractory Neocortical Epilepsy: rTMS Treatment
- ClinicalTrials.gov ID
- NCT00048490
- Acronym / sponsor ID
- 030024
- Conditions
- Epilepsy
- Keywords
- Seizures, Magnetism, Brain, Stimulation, Therapy, Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Oct 2002
- Study completion
- Oct 2004
- First posted
- 1 Nov 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, or TMS (described below), to treat epilepsy in certain patients whose seizures persist despite optimum medical treatment. TMS used in this study is intended to lessen the number of seizures a patient has by decreasing excitability of the brain in the region where the seizures originate.
Patients between 5 and 65 years of age who have had epilepsy for two or more years and have had at least one seizure a week for at least 6 months may be eligible for this 18-week study. Their seizures must come from a neocortical focus-that is, near the surface of the brain. Candidates will be selected from the NIH Epilepsy clinic and will be screened with an electroencephalogram (EEG), magnetic resonance imaging (MRI) scans, and blood tests.
Participants will keep a diary of the seizures they experience over an 8-week period. After the 8 weeks, they will come to the NIH outpatient clinic for 6 consecutive days for the following procedures:
- Day 1: A regular clinic visit, plus 6 hours of video-EEG recording (described below)
- Days 2 through 5: Video-EEG monitoring and TMS as follows:
8:00 - 11: 00 a.m. 3 hours video-EEG monitoring
11:00 - 12:30 p.m. TMS (includes set-up time; actual stimulation time lasts 30 minutes)
12:30 - 3:00 p.m. Lunch + rest
3:00 - 4:30 p.m. TMS
4:30 - 7:30 p.m. 3 hours video-EEG monitoring
(On the fifth day, subjects will have 6 hours of video-EEG monitoring in the afternoon instead of 3 hours.)
Participants will be randomly assigned to one of two TMS groups. One group will have TMS delivered in a way that is thought to have a chance of reducing seizures; the other will have sham, or placebo, stimulation.
When the TMS sessions are completed, participants will keep a diary of their seizures for another 8 weeks.
Transcranial Magnetic Stimulation
For TMS, an insulated wire coil is placed on the subject's scalp. A brief electrical current passes through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the cortex, or outer part of the brain. The stimulation may cause muscle, hand or arm twitching, or may cause twitches or temporary tingling in the forearm, head, or face muscles. During the stimulation, electrical activity of muscles is recorded with a computer or other recording device, using electrodes attached to the skin with tape. Some TMS sessions may be videotaped.
Video-EEG Recordings
The EEG recording device is housed in a small pouchlike container that is worn below the shoulder, attached to a belt worn around the waist.
Detailed description
In this study, we will use repetitive transcranial magnetic stimulation (rTMS) at 1.0 Hz to treat patients with poorly controlled neocortical epilepsy refractory to pharmacological treatments as a continuation of our previous study (1.0 Hz TMS in 24 patients with refractory partial epilepsy). Previously, we observed that 1.0 Hz rTMS reduced seizure frequency during the first 2 weeks after TMS, although the difference did not reach statistical significance. However, the results suggested that patients with neocortical temporal foci would have a better response than those with mesial temporal foci. We wish to see whether rTMS leads to a significant reduction in seizure frequency in neocortical epilepsy considering the depth of magnetic field. The design will include two parallel groups, one receiving active treatment, and one sham stimulation directed away from the epileptic focus. The patients and the rating physicians will be blinded to the treatment. 1.0 Hz TMS is a rate proven to induce long term depression in animal models and reported to decrease the excitability of both human and animal cerebral cortex. Our preliminary controlled study showed a trend for reduced seizure frequency after 1.0 Hz stimulation. The main outcome measure will be a reduction in seizure frequency over two weeks after stimulation.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients will be selected from the ERB, NINDS, NIH Epilepsy Clinic.
- Age 5 to 65 at entry to protocol.
- History of localization-related epilepsy for two or more years.
- Patients are on a stable anti-convulsant regimen defined as unchanged medicines and dose modifications lower than 20% in the last month. Blood levels of anticonvulsants will be measured at the beginning of the study, prior to stimulation and after the study to assure that the type and dose of medication will remain constant.
- Seizures are not completely responsive to medical treatment (1 or more seizures per week for at least 6 months) and patients have continued seizures despite best medical treatment in the past.
Key exclusion criteria (7 listed)
- are pregnant women (tested with urine pregnancy test). The effects of rTMS on pregnancy are unknown.
- have severe coronary disease.
- have increased intracranial pressure as expressed by the presence of papilledema.
- have cardiac pacemakers.
- take neuroleptic or antidepressant medications.
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 |
|---|---|---|
| transcranial magnetic stimulation (TMS) | 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.
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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?
A Phase 2 study testing transcranial magnetic stimulation (TMS) in people with Epilepsy, 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 6 inclusion and 7 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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.