EpilepsyPhase 2BRAINSTIMNCT02465970
Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy
A Phase 2 study testing STARSTIM in people with Epilepsy, run by Rennes University Hospital at 1 site in France.
Trial summary
Drug-resistant partial epilepsy has a heavy impact on quality of life and sometimes on life expectancy itself. Only a minority of patients may benefit from a curative epilepsy surgery. Neurostimulation, which can be an effective add-on treatment, is currently mainly represented by vagus nervus stimulation. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- STARSTIM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2015to Dec 2018
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 15 years;
- Patients with drug-partial resistant epilepsy with the following characteristics:
- Disabling epilepsy despite an optimized pharmacological treatment.
- An average of one seizure a day or more during the week preceding the inclusion
- Focal epilepsy in which epileptogenic zone is documented by paraclinical examinations consistent with clinical data
- Existence of measurable EEG markers of epilepsy
- Anti-epileptic drug treatment unmodified during the 2 weeks preceding the inclusion no change to treatment planned during the study.
- Signed informed consent.
Who cannot join
- Patients under 15 years;
- Patients in which a standard quality EEG recording is not possible
- Patients with ictal bradycardia or ictal syncope ;
- Patients with heart disease which may result in heart arrhythmia ;
- Incapacitated patients (curatorship, guardianship), patients deprived of liberty.
- Pregnant or lactating women
- Vagus nervus stimulation is not an exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BRAINSTIM : Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy
Drug-resistant partial epilepsy has a heavy impact on quality of life and sometimes on life expectancy itself. Only a minority of patients may benefit from a curative epilepsy surgery. Neurostimulation, which can be an effective add-on treatment, is currently mainly represented by vagus nervus stimulation. Transcranial direct current stimulation, a non -invasive technique already used in other areas of neurology, may be efficient on some partial epilepsies, in particular through the individual configuration of stimulation, made possible by recent technological advances.
Main goal : To study the effect of transcranial electrical stimulation on the frequency of seizures in patients with drug-resistant partial epilepsy.
Hypothesis : Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation.
- Conditions
- Epilepsy
- Being tested
- STARSTIM, sham TDCS
- Keywords
- Transcranial Direct Current Stimulation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARSTIMDevice
Also called TDCS TransCranial Direct Current Stimulation
Multifocal transcranial direct current stimulation.
- CE-marked device, comprising a cap with 2 to 8 electrodes, connected with a programmable mobile stimulator.
- The stimulation is applied during a 60 min session
sham TDCSDevice
| Study group | Role | What they receive |
|---|---|---|
| TDCS session | Experimental | Intervention : Stimulation is applied during a 60 min session with STARSTIM Receives: Device: STARSTIM |
| TDCS Placebo | Placebo comparator | Intervention : Stimulation is not applied during a 60 min session with STARSTIM Receives: Device: sham TDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation.
Measured: 24 hours
Secondary outcomes (6)
Clinical : - Significant reduction of the frequency of occurrence of seizures within 24 hours, 48 hours, and 7 days following a session of TDCS.
Measured: 24 hours until 7 days
Clinical : - Reduction in the duration of seizures
Measured: 6 months
Electrophysiological : Decrease of epileptic EEG paroxysms at 8 and 24 hours after a TDCS session
Measured: 8-24 hours
- Clinical : If appropriate, reduction of the frequency of occurrence of secondary generalized seizures.
Measured: 6 months
-Clinical : Improvement in the quality of life within 7 days following a TDCS session
Measured: 7 days
Electrophysiological : - Decrease of epileptic EEG paroxysms immediately following a TDCS session.
Measured: up to 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study start13 Nov 2015
- Primary completionNov 2018
- Study completionDec 2018
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 Rennes University HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BIRABEN Arnaud, Principal investigator, Rennes HU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465970
- Sponsor's protocol ID
- 35RC14_9808
- Acronym
- BRAINSTIM
- Status last verified
- Jan 2019
- First submitted
- 1 Jun 2015
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAINSTIM : Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy
- ClinicalTrials.gov ID
- NCT02465970
- Acronym / sponsor ID
- BRAINSTIM / 35RC14_9808
- Conditions
- Epilepsy
- Keywords
- Transcranial Direct Current Stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 13 Nov 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 Jun 2015 (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.
Drug-resistant partial epilepsy has a heavy impact on quality of life and sometimes on life expectancy itself. Only a minority of patients may benefit from a curative epilepsy surgery. Neurostimulation, which can be an effective add-on treatment, is currently mainly represented by vagus nervus stimulation. Transcranial direct current stimulation, a non -invasive technique already used in other areas of neurology, may be efficient on some partial epilepsies, in particular through the individual configuration of stimulation, made possible by recent technological advances.
Main goal : To study the effect of transcranial electrical stimulation on the frequency of seizures in patients with drug-resistant partial epilepsy.
Hypothesis : Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDCS session | Experimental | Device: STARSTIMIntervention : Stimulation is applied during a 60 min session with STARSTIM |
| TDCS Placebo | Placebo comparator | Device: sham TDCSIntervention : Stimulation is not applied during a 60 min session with STARSTIM |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age greater than or equal to 15 years;
- Patients with drug-partial resistant epilepsy with the following characteristics:
- Disabling epilepsy despite an optimized pharmacological treatment.
- An average of one seizure a day or more during the week preceding the inclusion
- Focal epilepsy in which epileptogenic zone is documented by paraclinical examinations consistent with clinical data
Key exclusion criteria (7 listed)
- Patients under 15 years;
- Patients in which a standard quality EEG recording is not possible
- Patients with ictal bradycardia or ictal syncope ;
- Patients with heart disease which may result in heart arrhythmia ;
- Incapacitated patients (curatorship, guardianship), patients deprived of liberty.
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 |
|---|---|---|
| STARSTIMAlso: TDCS TransCranial Direct Current StimulationMultifocal transcranial direct current stimulation. * CE-marked device, comprising a cap with 2 to 8 electrodes, connected with a programmable mobile stimulator. * The stimulation is applied during a 60 min session | Device | TDCS session |
| sham TDCS | Device | TDCS Placebo |
Primary outcome
Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation.
Time frame: 24 hours
6 secondary outcomes
Clinical : - Significant reduction of the frequency of occurrence of seizures within 24 hours, 48 hours, and 7 days following a session of TDCS.
Time frame: 24 hours until 7 days
Clinical : - Reduction in the duration of seizures
Time frame: 6 months
Electrophysiological : Decrease of epileptic EEG paroxysms at 8 and 24 hours after a TDCS session
Time frame: 8-24 hours
- Clinical : If appropriate, reduction of the frequency of occurrence of secondary generalized seizures.
Time frame: 6 months
-Clinical : Improvement in the quality of life within 7 days following a TDCS session
Time frame: 7 days
Electrophysiological : - Decrease of epileptic EEG paroxysms immediately following a TDCS session.
Time frame: up to 1 min
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 9 Jan 2019.
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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.
BIRABEN Arnaud principal investigator
Rennes HU
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 STARSTIM in people with Epilepsy, run by Rennes University Hospital at 1 site in France.
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 8 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 9 Jan 2019. 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 France. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation. (time frame: 24 hours). 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 9 Jan 2019.