Temporal Lobe EpilepsyNCT00344877
Electrical Brain Stimulation to Reduce Epileptic Seizures
An observational study of Temporal Lobe Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
OBJECTIVES: About 15% of patients suffering from focal epilepsy are refractory to available pharmacological treatments. Until now, the only hope for such patients has been the development of new pharmaceutical treatments or epilepsy surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Temporal Lobe Epilepsy
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2006to 5 May 2009
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be included under the following circumstances:
- Age between 18 to 80 years.
- Written informed consent is given by the patient.
- Epileptogenic focus in the temporal lobe or in the frontal lobe (unilateral or bilateral with dominant focus).
- Seizures are not completely responsive to medical treatment (8 or more seizures per month for at least 3 months) and patients have failed at least two anticonvulsant regimens in the past. The implantation of a vagus nerve stimulator will also be counted as anticonvulsant regimen.
- A stable anticonvulsant regimen (not more than three anticonvulsants) defined as unchanged dose or dose modifications lower than 20% in the last month (Blood levels of anticonvulsants will be measured at the beginning of the study, prior and after intervention, and after the study to assure that the type and dose of medication remains constant). For the vagus nerve stimulator, the stimulation parameters will have to be unchanged for at least one month.
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- One antidepressant on a stable dose regimen for at least 1 month will be allowed.
- Mini-Mental-Status examination greater than or equal to 23 points.
- Commitment to participate in the long-term follow-up (up to 5 months).
Who cannot join
- We will exclude patients if one of the following conditions applies:
- A history of any neurological illness other than the epilepsy.
- Acute symptomatic seizures (caused by brain tumor, acute stroke, intracranial hemorrhage, encephalitis) or psychogenic seizures.
- Generalized epilepsy or focal epilepsy with the epileptogenic zone outside the temporal lobe.
- A history of severe alcohol or drug abuse; psychiatric illness such as severe, clinically significant depression (as evaluated by BDI); poor motivational capacity; or severe language disturbances, particularly of receptive nature or with serious cognitive deficits.
- More than moderate uncontrolled medical problems (e.g., cardiovascular disease, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, hypo/hyperthyroidism, severe diabetes, peripheral arteriopathy, or a deteriorated condition due to age, or other medical conditions as determined by the study physician, that would interfere with participation in this study).
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- Increased intracranial pressure as evaluated by clinical means (presence of papilledema in eye ground exam, compressed sulci/ventricle on MRI scan).
- Previous implantation of metallic material (e.g., vascular clips, cochlear implant) in the cranium (except in the mouth), pacemaker, implanted medication pumps, neural stimulators. This does not apply for implantation of a vagus nerve stimulator (Cyberonics ® (Registered Trademark) [Registered Trademark] 100, 102 or 102R).
- Drug treatment acting primarily on the central nervous system (other than the regular anticonvulsant treatment and one antidepressant) that lowers the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.
- Diseased or damaged skin over the face or scalp.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Anticonvulsive Effects of Transcranial DC Stimulation in Pharmacoresistant Focal Epilepsy
OBJECTIVES:
About 15% of patients suffering from focal epilepsy are refractory to available pharmacological treatments. Until now, the only hope for such patients has been the development of new pharmaceutical treatments or epilepsy surgery. In case of inoperability, different types of invasive brain stimulation such as vagus nerve stimulation or deep brain stimulation or non-invasive repetitive TMS have been evaluated to determine their anticonvulsive potential. For rTMS, weak and short lasting seizure reduction has been reported in different epilepsy syndromes.
Read more
A new, non-invasive stimulation technique, transcranial direct current stimulation (tDCS), was useful to modulate cortical excitability in many cortical areas (M1, visual cortex, frontal cortex). Cathodal tDCS, with a current of 1 mA, induced long-term depression in animal models and reportedly decreased the excitability of both human and animal cerebral cortex. In epilepsy patients suffering from a malformation of cortical development, a single session of cathodal tDCS helped reduce seizures briefly. The purpose of this protocol is to study the effects of repeated applications of tDCS on the excitability of the seizure focus in patients with poorly controlled pharmacologically refractory temporal lobe epilepsy.
STUDY POPULATION:
We plan to study 56 patients between the ages of 18 and 80 suffering from temporal lobe epilepsy.
DESIGN:
Subjects will be allocated by blocked randomization to one of two groups (parallel design). Group A will receive cathodal tDCS and group B will receive Sham-tDCS on five consecutive days. Each subject will participate in 9 sessions (1 baseline visit, 5 intervention visits, 3 follow-up visits). The effect of the intervention relative to the sham stimulation will be evaluated by comparing seizure frequency and neuropsychological tests during the 8 weeks before and after the intervention.
OUTCOME MEASURES:
Primary outcome measure will be the mean seizure frequency per 4 weeks in the tDCS group as compared to the Sham-tDCS group. To analyze the effect of the intervention (tDCS), seizures will be evaluated during a 2x4 week baseline period before tDCS and 2x4 weeks after the intervention. Using these data we will calculate the percentage change of seizures per 4 weeks.
Secondary outcome measures will be the scores of the neuropsychological testing (HVLT-R, BVMT-R, CTMT, COWAT) and number of epileptiform discharges in the EEG. Furthermore, th...
Read the detailed description
OBJECTIVES:
About 15% of patients suffering from focal epilepsy are refractory to available pharmacological treatments. Until now, the only hope for such patients has been the development of new pharmaceutical treatments or epilepsy surgery. In case of inoperability, different types of invasive brain stimulation such as vagus nerve stimulation or deep brain stimulation or non-invasive repetitive TMS have been evaluated to determine their anticonvulsive potential. For rTMS, weak and short lasting seizure reduction has been reported in different epilepsy syndromes.
A new, non-invasive stimulation technique, transcranial direct current stimulation (tDCS), was useful to modulate cortical excitability in many cortical areas (M1, visual cortex, frontal cortex). Cathodal tDCS, with a current of 1 mA, induced long-term depression in animal models and reportedly decreased the excitability of both human and animal cerebral cortex. In epilepsy patients suffering from a malformation of cortical development, a single session of cathodal tDCS applied to various cortical areas including frontal and temporal cortex helped reduce seizures briefly. The purpose of this protocol is to study the effects of repeated applications of tDCS on the excitability of the seizure focus in patients with poorly controlled pharmacologically refractory frontal and/or temporal lobe epilepsy.
STUDY POPULATION:
We plan to study 56 patients between the ages of 18 and 80 suffering from frontal and/or temporal lobe epilepsy.
DESIGN:
Subjects will be allocated by blocked randomization to one of two groups (parallel design). Group A will receive cathodal tDCS and group B will receive Sham-tDCS on five consecutive days. Each subject will participate in 9 sessions (1 baseline visit, 5 intervention visits, 3 follow-up visits). The effect of the intervention relative to the sham stimulation will be evaluated by comparing seizure frequency and neuropsychological tests during the 8 weeks before and after the intervention.
OUTCOME MEASURES:
Primary outcome measure will be the mean seizure frequency per 4 weeks in the tCDS group as compared to the Sham-tDCS group. To analyze the effect of the intervention (tDCS), seizures will be evaluated during a 2x4 week baseline period before tDCS and a 2x4 weeks after the intervention. Using these data we will calculate the percentage change of seizures/4 weeks.
Secondary outcome measures will be the scores of the neuropsychological testing (HVLT-R, BVMT-R, CTMT, COWAT) and number of epileptiform discharges in the EEG. Furthermore, the patients will answer several questionnaires to evaluate quality of life (QOLIE-31-P), seizure severity (SSQ), and mood (BDI). To better understand the mechanisms underlying the proposed change of seizure frequency, we will use single- and paired- pulse transcranial magnetic stimulation (TMS) to identify corticomotor excitability changes.
- Conditions
- Temporal Lobe Epilepsy
- Keywords
- Epilepsy, Temporal Lobe Epilepsy, Cortical Excitability, Transcranial Direct Current Stimulation (tDCS), Memory Testing, Seizures, Transcranial Magnetic Stimulation (TMS), Memory, Plasticity
- Medical subject headings
- Epilepsy, Temporal Lobe, Epilepsy, Seizures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study start19 Jun 2006
- Study completion5 May 2009
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 Temporal Lobe EpilepsyStudies 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
- 56 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
- NCT00344877
- Sponsor's protocol ID
- 060187
- Other IDs
- 06-N-0187
- Status last verified
- 5 May 2009
- First submitted
- 23 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Sander JW. Some aspects of prognosis in the epilepsies: a review. Epilepsia. 1993 Nov-Dec;34(6):1007-16. doi: 10.1111/j.1528-1157.1993.tb02126.x.
PubMed 8243349Sander JW, Shorvon SD. Epidemiology of the epilepsies. J Neurol Neurosurg Psychiatry. 1996 Nov;61(5):433-43. doi: 10.1136/jnnp.61.5.433. No abstract available.
PubMed 8965090Theodore WH, Hunter K, Chen R, Vega-Bermudez F, Boroojerdi B, Reeves-Tyer P, Werhahn K, Kelley KR, Cohen L. Transcranial magnetic stimulation for the treatment of seizures: a controlled study. Neurology. 2002 Aug 27;59(4):560-2. doi: 10.1212/wnl.59.4.560.
PubMed 12196649
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticonvulsive Effects of Transcranial DC Stimulation in Pharmacoresistant Focal Epilepsy
- ClinicalTrials.gov ID
- NCT00344877
- Acronym / sponsor ID
- 060187
- Conditions
- Temporal Lobe Epilepsy
- Keywords
- Epilepsy, Temporal Lobe Epilepsy, Cortical Excitability, Transcranial Direct Current Stimulation (tDCS), Memory Testing, Seizures, Transcranial Magnetic Stimulation (TMS), Memory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 19 Jun 2006
- Study completion
- 5 May 2009
- First posted
- 27 Jun 2006 (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.
OBJECTIVES:
About 15% of patients suffering from focal epilepsy are refractory to available pharmacological treatments. Until now, the only hope for such patients has been the development of new pharmaceutical treatments or epilepsy surgery. In case of inoperability, different types of invasive brain stimulation such as vagus nerve stimulation or deep brain stimulation or non-invasive repetitive TMS have been evaluated to determine their anticonvulsive potential. For rTMS, weak and short lasting seizure reduction has been reported in different epilepsy syndromes.
A new, non-invasive stimulation technique, transcranial direct current stimulation (tDCS), was useful to modulate cortical excitability in many cortical areas (M1, visual cortex, frontal cortex). Cathodal tDCS, with a current of 1 mA, induced long-term depression in animal models and reportedly decreased the excitability of both human and animal cerebral cortex. In epilepsy patients suffering from a malformation of cortical development, a single session of cathodal tDCS helped reduce seizures briefly. The purpose of this protocol is to study the effects of repeated applications of tDCS on the excitability of the seizure focus in patients with poorly controlled pharmacologically refractory temporal lobe epilepsy.
STUDY POPULATION:
We plan to study 56 patients between the ages of 18 and 80 suffering from temporal lobe epilepsy.
DESIGN:
Subjects will be allocated by blocked randomization to one of two groups (parallel design). Group A will receive cathodal tDCS and group B will receive Sham-tDCS on five consecutive days. Each subject will participate in 9 sessions (1 baseline visit, 5 intervention visits, 3 follow-up visits). The effect of the intervention relative to the sham stimulation will be evaluated by comparing seizure frequency and neuropsychological tests during the 8 weeks before and after the intervention.
OUTCOME MEASURES:
Primary outcome measure will be the mean seizure frequency per 4 weeks in the tDCS group as compared to the Sham-tDCS group. To analyze the effect of the intervention (tDCS), seizures will be evaluated during a 2x4 week baseline period before tDCS and 2x4 weeks after the intervention. Using these data we will calculate the percentage change of seizures per 4 weeks.
Secondary outcome measures will be the scores of the neuropsychological testing (HVLT-R, BVMT-R, CTMT, COWAT) and number of epileptiform discharges in the EEG. Furthermore, th...
Detailed description
OBJECTIVES:
About 15% of patients suffering from focal epilepsy are refractory to available pharmacological treatments. Until now, the only hope for such patients has been the development of new pharmaceutical treatments or epilepsy surgery. In case of inoperability, different types of invasive brain stimulation such as vagus nerve stimulation or deep brain stimulation or non-invasive repetitive TMS have been evaluated to determine their anticonvulsive potential. For rTMS, weak and short lasting seizure reduction has been reported in different epilepsy syndromes.
A new, non-invasive stimulation technique, transcranial direct current stimulation (tDCS), was useful to modulate cortical excitability in many cortical areas (M1, visual cortex, frontal cortex). Cathodal tDCS, with a current of 1 mA, induced long-term depression in animal models and reportedly decreased the excitability of both human and animal cerebral cortex. In epilepsy patients suffering from a malformation of cortical development, a single session of cathodal tDCS applied to various cortical areas including frontal and temporal cortex helped reduce seizures briefly. The purpose of this protocol is to study the effects of repeated applications of tDCS on the excitability of the seizure focus in patients with poorly controlled pharmacologically refractory frontal and/or temporal lobe epilepsy.
STUDY POPULATION:
We plan to study 56 patients between the ages of 18 and 80 suffering from frontal and/or temporal lobe epilepsy.
DESIGN:
Subjects will be allocated by blocked randomization to one of two groups (parallel design). Group A will receive cathodal tDCS and group B will receive Sham-tDCS on five consecutive days. Each subject will participate in 9 sessions (1 baseline visit, 5 intervention visits, 3 follow-up visits). The effect of the intervention relative to the sham stimulation will be evaluated by comparing seizure frequency and neuropsychological tests during the 8 weeks before and after the intervention.
OUTCOME MEASURES:
Primary outcome measure will be the mean seizure frequency per 4 weeks in the tCDS group as compared to the Sham-tDCS group. To analyze the effect of the intervention (tDCS), seizures will be evaluated during a 2x4 week baseline period before tDCS and a 2x4 weeks after the intervention. Using these data we will calculate the percentage change of seizures/4 weeks.
Secondary outcome measures will be the scores of the neuropsychological testing (HVLT-R, BVMT-R, CTMT, COWAT) and number of epileptiform discharges in the EEG. Furthermore, the patients will answer several questionnaires to evaluate quality of life (QOLIE-31-P), seizure severity (SSQ), and mood (BDI). To better understand the mechanisms underlying the proposed change of seizure frequency, we will use single- and paired- pulse transcranial magnetic stimulation (TMS) to identify corticomotor excitability changes.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 to 80 years.
- Written informed consent is given by the patient.
- Epileptogenic focus in the temporal lobe or in the frontal lobe (unilateral or bilateral with dominant focus).
- Seizures are not completely responsive to medical treatment (8 or more seizures per month for at least 3 months) and patients have failed at least two anticonvulsant regimens in the past. The implantation of a vagus nerve stimulator will also be counted as anticonvulsant regimen.
- A stable anticonvulsant regimen (not more than three anticonvulsants) defined as unchanged dose or dose modifications lower than 20% in the last month (Blood levels of anticonvulsants will be measured at the beginning of the study, prior and after intervention, and after the study to assure that the type and dose of medication remains constant). For the vagus nerve stimulator, the stimulation parameters will have to be unchanged for at least one month.
Key exclusion criteria (11 listed)
- A history of any neurological illness other than the epilepsy.
- Acute symptomatic seizures (caused by brain tumor, acute stroke, intracranial hemorrhage, encephalitis) or psychogenic seizures.
- Generalized epilepsy or focal epilepsy with the epileptogenic zone outside the temporal lobe.
- A history of severe alcohol or drug abuse; psychiatric illness such as severe, clinically significant depression (as evaluated by BDI); poor motivational capacity; or severe language disturbances, particularly of receptive nature or with serious cognitive deficits.
- More than moderate uncontrolled medical problems (e.g., cardiovascular disease, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, hypo/hyperthyroidism, severe diabetes, peripheral arteriopathy, or a deteriorated condition due to age, or other medical conditions as determined by the study physician, that would interfere with participation in this study).
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 2 Jul 2017.
- Background: PubMed 8243349Sander JW. Some aspects of prognosis in the epilepsies: a review. Epilepsia. 1993 Nov-Dec;34(6):1007-16. doi: 10.1111/j.1528-1157.1993.tb02126.x.
- Background: PubMed 8965090Sander JW, Shorvon SD. Epidemiology of the epilepsies. J Neurol Neurosurg Psychiatry. 1996 Nov;61(5):433-43. doi: 10.1136/jnnp.61.5.433. No abstract available.
- Background: PubMed 12196649Theodore WH, Hunter K, Chen R, Vega-Bermudez F, Boroojerdi B, Reeves-Tyer P, Werhahn K, Kelley KR, Cohen L. Transcranial magnetic stimulation for the treatment of seizures: a controlled study. Neurology. 2002 Aug 27;59(4):560-2. doi: 10.1212/wnl.59.4.560.
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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 Temporal Lobe 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 9 inclusion and 11 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 2 Jul 2017. 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 NCT00344877, 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 2 Jul 2017.