EpilepsyNCT00625222
Transcranial Direct Current Stimulation (tDCS) As A Tool For Prospective Responder Identification Before Vagus Nerve Stimulation (VNS) Implantation
A study testing transcranial direct current stimulation in people with Epilepsy, run by University of Luebeck at 1 site in Germany.
Trial summary
The aim of the study is to establish tDCS as a prognostic tool to predict VNS therapy outcome among patients with pharmacoresistant epilepsy. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Jun 2010
- Phase
- Interventional
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 12 years and above
- At least 2 years disease history
- Refractory epilepsy:
- Seizures are not completely responsive to longlasting antiepileptic treatment. At least 4 antiepileptic medicaments failed in mono or combined anticonvulsive regimen.
- At least 4 seizures per week in the last month, despite adequate antiepileptic regimen.
- Epilepsy surgery is not indicated or not accepted by the patient or by the parents of the patient.
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- A stable anticonvulsive regimen, defined as unchanged dose and type of the antiepileptic medication in the last month before tDCS and before VNS implantation.
- Seizure diary is available and completed.
- VNS implantation is planned within the next 2 months.
Who cannot join
- Acute, symptomatic seizures (caused by tumor, stroke, acute encephalitis)
- Uncontrolled medical problems (e.g. cardiovascular, nephrotic oder severe, chronic or severe acute disease)
- Increased intracranial pressure for whatever reason
- Implantation of metallic material (e.g. pacemaker, cochlear-implant)
- Diseased or damaged skin over the scalp (e.g. Dermatitis)
- Pregnancy
- Known or supposed non-compliance
- Age: less than 12 years
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Pediatrics Department, University of Luebeck
Lübeck, 23538
About this study
The aim of the study is to establish tDCS as a prognostic tool to predict VNS therapy outcome among patients with pharmacoresistant epilepsy.
Read the detailed description
In recent years it has been shown that many different brain stimulation techniques are effective in seizure reduction in epilepsy patients as well as in animal models of epilepsy. VNS is the method most often used with at least 45.000 patients implanted with this device worldwide. However, prediction of seizure outcome after VNS implantation is not possible in an individual patient so far. Recently, tDCS is increasingly used as a method to reduce seizure frequency in epileptic patients. Therefore it is hypothesized, that a positive effect after a single tDCS, in terms of short time seizure reduction and reduction of epileptic discharges in the EEG, could be predictive for epilepsy outcome after VNS implantation.
In the proposed multicenter prognostic study we test the predictive value of tDCS for each patient with refractory epilepsy 1 week up to 2 months before VNS implantation. The effects of tDCS will be verified via a 15 minutes long routine EEG examination, performed immediately before and after tDCS, together with seizure diary and seizure severity scale, assessed 1 month before and 1 week after tDCS. A 6 months long observation period will follow the VNS implantation. At the end of the 6 months period seizure diary and seizure severity scale of the last month will be performed to measure VNS therapy outcome. On the basis of the described variables, immediate up to 1 week long tDCS effects will be correlated to 6 months long VNS therapy outcome.
- Conditions
- Epilepsy
- Being tested
- transcranial direct current stimulation
- Keywords
- Electroencephalography, Seizure frequency, Seizure severity
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationProcedure or surgery
1mA, 15 Minutes, constant direct current
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of tDCS effects in terms of EEG changes, number of seizures and seizure severity to VNS therapy outcome
Measured: 6 Months
Secondary outcomes (1)
To define criteria which will have predictive value for VNS therapy outcome.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
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.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- Cyberonics, Inc., University Hospital, Bonn, University of Erlangen-Nürnberg Medical School, Epilepsycenter Bielefeld
- Investigators
- Jürgen Sperner, Prof., M.D., Study chair, Pediatrics Department, University of Luebeck, GermanyIren Orosz, M.D., Principal investigator, Pediatrics Department, University of Luebeck, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625222
- Sponsor's protocol ID
- tDCS-VNS001
- Other IDs
- AZ07-135
- Status last verified
- Jan 2010
- First submitted
- 11 Feb 2008
- Last updated
- 28 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) As A Tool For Prospective Responder Identification Before Vagus Nerve Stimulation (VNS) Implantation
- ClinicalTrials.gov ID
- NCT00625222
- Acronym / sponsor ID
- tDCS-VNS001
- Conditions
- Epilepsy
- Keywords
- Electroencephalography, Seizure frequency, Seizure severity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- Cyberonics, Inc., University Hospital, Bonn, University of Erlangen-Nürnberg Medical School, Epilepsycenter Bielefeld
- Study start
- Sep 2007
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 28 Feb 2008 (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.
The aim of the study is to establish tDCS as a prognostic tool to predict VNS therapy outcome among patients with pharmacoresistant epilepsy.
Detailed description
In recent years it has been shown that many different brain stimulation techniques are effective in seizure reduction in epilepsy patients as well as in animal models of epilepsy. VNS is the method most often used with at least 45.000 patients implanted with this device worldwide. However, prediction of seizure outcome after VNS implantation is not possible in an individual patient so far. Recently, tDCS is increasingly used as a method to reduce seizure frequency in epileptic patients. Therefore it is hypothesized, that a positive effect after a single tDCS, in terms of short time seizure reduction and reduction of epileptic discharges in the EEG, could be predictive for epilepsy outcome after VNS implantation.
In the proposed multicenter prognostic study we test the predictive value of tDCS for each patient with refractory epilepsy 1 week up to 2 months before VNS implantation. The effects of tDCS will be verified via a 15 minutes long routine EEG examination, performed immediately before and after tDCS, together with seizure diary and seizure severity scale, assessed 1 month before and 1 week after tDCS. A 6 months long observation period will follow the VNS implantation. At the end of the 6 months period seizure diary and seizure severity scale of the last month will be performed to measure VNS therapy outcome. On the basis of the described variables, immediate up to 1 week long tDCS effects will be correlated to 6 months long VNS therapy outcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: transcranial direct current stimulation |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 12 years and above
- At least 2 years disease history
- Refractory epilepsy:
- A stable anticonvulsive regimen, defined as unchanged dose and type of the antiepileptic medication in the last month before tDCS and before VNS implantation.
- Seizure diary is available and completed.
Key exclusion criteria (8 listed)
- Acute, symptomatic seizures (caused by tumor, stroke, acute encephalitis)
- Uncontrolled medical problems (e.g. cardiovascular, nephrotic oder severe, chronic or severe acute disease)
- Increased intracranial pressure for whatever reason
- Implantation of metallic material (e.g. pacemaker, cochlear-implant)
- Diseased or damaged skin over the scalp (e.g. Dermatitis)
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 direct current stimulation1mA, 15 Minutes, constant direct current | Procedure or surgery | 1 |
Primary outcome
Correlation of tDCS effects in terms of EEG changes, number of seizures and seizure severity to VNS therapy outcome
Time frame: 6 Months
1 secondary outcome
To define criteria which will have predictive value for VNS therapy outcome.
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2010.
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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.
Jürgen Sperner, Prof., M.D. study chair
Pediatrics Department, University of Luebeck, Germany
Iren Orosz, M.D. principal investigator
Pediatrics Department, University of Luebeck, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Epilepsy, run by University of Luebeck at 1 site in Germany.
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 8 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: status not confirmed, as of the sponsor's last update on 28 Jan 2010. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jürgen Sperner, Prof. M.D. (+49-451-500-2605, sperner@paedia.ukl.mu-luebeck.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of tDCS effects in terms of EEG changes, number of seizures and seizure severity to VNS therapy outcome (time frame: 6 Months). It is what the study was designed to measure, not a finding.
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 28 Jan 2010.