EpilepsyNCT01415362
Closed-loop System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy
A study testing Transcranial Direct Current Stimulation in people with Epilepsy and Seizures, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
In this pilot study, the researchers investigated the feasibility of a closed-loop electroencephalography (EEG) / transcranial direct current stimulation (tDCS) system for treatment of epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jul 2014
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Disabling motor simple partial seizures, complex partial seizures, and/or secondarily generalized seizures. Disabling refers to seizures that are severe enough to significantly impair functional abilities in areas such as employment, psychological or social wellbeing, education or mobility.
- Failed treatment with a minimum of two antiepileptic medications.
- Experienced an average of three or more disabling simple weekly partial seizures, complex partial seizures and/or secondarily generalized seizures.
- Between the ages of 18 and 70 years.
- No more than two epileptogenic regions in the brain.
- Must be able to provide informed consent themselves.
- Healthy subjects age 18 and older
Who cannot join
- Has a progressive neurological or systemic disease.
- Has a history of nonepileptic seizures.
- Has an implanted metallic device, aneurysm clips, cochlear implants, or spinal cord stimulator.
- Has suffered a severe traumatic brain injury with skull fracture.
- Contraindications to tDCS
- metal in the head
Show all 18Show fewer
- implanted brain medical devices
- Pregnancy
- Any implanted electrical medical device, including pacers and implanted cardiac defibrillators
- Existence of major neurologic or psychiatric condition (i.e. epilepsy, severe depression)
- History of head injury resulting in more than a momentary loss of consciousness
- Previous neurosurgery
- A history of significant alcohol or drug abuse in the prior 6 months
- Presence of unstable medical conditions, such as; uncontrolled diabetes mellitus, cardiac pathology, cancer, kidney insufficiency, acute thrombosis
- Contraindication to tDCS
- metal in the head
- implanted electronic medical devices
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
About this study
Official title: Development of a Closed-loop Detect-and-treat System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy
In this pilot study, the researchers investigated the feasibility of a closed-loop electroencephalography (EEG) / transcranial direct current stimulation (tDCS) system for treatment of epilepsy. They looked to see the feasibility of triggering tDCS stimulation within 10 seconds of a detected EEG partial-onset seizure, and also a proof-of-principle determination of whether tDCS applied during this vulnerable period may be feasible to prevent the oncoming seizure.
This study required 5 visits over the course of approximately 8 weeks. Each visit was separated by at least 2 weeks. Two of the visits had 24-hour EEG monitoring sessions. During these two sessions, the EEG and tDCS were hooked into a closed loop system, such that when seizure activity wasdetected, the tDCS was triggered to deliver stimulation. Subjects received active stimulation or sham stimulation sessions during the first 24-hour visit, and the opposite during the second. The subjects were randomized and counterbalanced.
We have also added a healthy subjects cohort to assess the feasibility of the closed loop system. In order to test the proof-of-concept of this system, the experiment will focus on detecting and acting upon alpha- and beta-band changes traced in the EEG activity that is being recorded, and provide tDCS stimulation based upon those changes. We will enroll 6 subjects who will have 2 visits each. During these two visits subjects will be randomized to active or sham stimulation sessions and receive the opposite during their second visit.
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- transcranial direct current stimulation, electroencephalography
- 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 Direct Current StimulationDevice
Also called low intensity 1x1 direct current stimulator
For both active and sham tDCS, the device will be hooked up to the closed loop system, using electrodes of 35cm^2. During active tDCS, the subject will receive 2mA for 5 min. During sham tDCS, the current will only be active for 30 seconds (current ramping up and then down) to simulate the sensations of active tDCS.
The subject will undergo either active or sham stimulation for their first 24-hour EEG monitoring visit, and the opposite intervention on the second 24-hour EEG monitoring visit.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | The subject will receive sessions of active tDCS remotely triggered by the EEG monitoring system each time seizure activity is detected during the 24-hour period. Receives: Device: Transcranial Direct Current Stimulation |
| Sham tDCS | Sham comparator | The subject will receive sessions of sham tDCS remotely triggered by the EEG monitoring system each time seizure activity is detected during the 24-hour period. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of seizure activity via electroencephalography (EEG)
Measurement of seizure activity will take place in two visits of 24-hour seizure monitoring. During these visits, the EEG will record seizure information including (1) number of seizures, (2) severity of seizures, and (3) latency of seizures between sessions of stimulation.
Measured: Measured for approximately 48 hours
Secondary outcomes (3)
Subject self-report of seizure activity
Subject will keep a diary to monitor baseline seizure activity between study visits. This will be measured daily for the 8 weeks the subject will participate.
Measured: Measured for approximately 8 weeks.
Measurement of healthy subjects EEG changes
We will compare changes in EEG from before stimulation to after stimulation in a healthy cohort. We will test the system to trigger in healthy subjects when there is an increase of beta frequency power and decrease of alpha frequency power. We will also assess whether the tDCS stimulation will return the background EEG rhythm toward a baseline pattern (increasing alpha, decreasing beta)
Measured: Measured for approximately 2 hours
N-back memory and attention test
We will assess working memory and attention in healthy individuals using the n-back test, assessing changes from pre- to post-tDCS
Measured: Measured for approximately 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2014
- Study completionJul 2014
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Fregni, Spaulding Rehabilitation Hospital
- Investigators
- Felipe Fregni, MD, PhD, MPH, Principal investigator, Spaulding Rehabilitation Hospital (SRH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415362
- Sponsor's protocol ID
- 2010-p-000289
- Status last verified
- Apr 2020
- First submitted
- 26 Jul 2011
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Closed-loop Detect-and-treat System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy
- ClinicalTrials.gov ID
- NCT01415362
- Acronym / sponsor ID
- 2010-p-000289
- Keywords
- transcranial direct current stimulation, electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Aug 2011 (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.
In this pilot study, the researchers investigated the feasibility of a closed-loop electroencephalography (EEG) / transcranial direct current stimulation (tDCS) system for treatment of epilepsy. They looked to see the feasibility of triggering tDCS stimulation within 10 seconds of a detected EEG partial-onset seizure, and also a proof-of-principle determination of whether tDCS applied during this vulnerable period may be feasible to prevent the oncoming seizure.
This study required 5 visits over the course of approximately 8 weeks. Each visit was separated by at least 2 weeks. Two of the visits had 24-hour EEG monitoring sessions. During these two sessions, the EEG and tDCS were hooked into a closed loop system, such that when seizure activity wasdetected, the tDCS was triggered to deliver stimulation. Subjects received active stimulation or sham stimulation sessions during the first 24-hour visit, and the opposite during the second. The subjects were randomized and counterbalanced.
We have also added a healthy subjects cohort to assess the feasibility of the closed loop system. In order to test the proof-of-concept of this system, the experiment will focus on detecting and acting upon alpha- and beta-band changes traced in the EEG activity that is being recorded, and provide tDCS stimulation based upon those changes. We will enroll 6 subjects who will have 2 visits each. During these two visits subjects will be randomized to active or sham stimulation sessions and receive the opposite during their second visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: Transcranial Direct Current StimulationThe subject will receive sessions of active tDCS remotely triggered by the EEG monitoring system each time seizure activity is detected during the 24-hour period. |
| Sham tDCS | Sham comparator | Device: Transcranial Direct Current StimulationThe subject will receive sessions of sham tDCS remotely triggered by the EEG monitoring system each time seizure activity is detected during the 24-hour period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Disabling motor simple partial seizures, complex partial seizures, and/or secondarily generalized seizures. Disabling refers to seizures that are severe enough to significantly impair functional abilities in areas such as employment, psychological or social wellbeing, education or mobility.
- Failed treatment with a minimum of two antiepileptic medications.
- Experienced an average of three or more disabling simple weekly partial seizures, complex partial seizures and/or secondarily generalized seizures.
- Between the ages of 18 and 70 years.
- No more than two epileptogenic regions in the brain.
Key exclusion criteria (18 listed)
- Has a progressive neurological or systemic disease.
- Has a history of nonepileptic seizures.
- Has an implanted metallic device, aneurysm clips, cochlear implants, or spinal cord stimulator.
- Has suffered a severe traumatic brain injury with skull fracture.
- Contraindications to tDCS
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 StimulationAlso: low intensity 1x1 direct current stimulatorFor both active and sham tDCS, the device will be hooked up to the closed loop system, using electrodes of 35cm^2. During active tDCS, the subject will receive 2mA for 5 min. During sham tDCS, the current will only be active for 30 seconds (current ramping up and then down) to simulate the sensations of active tDCS. The subject will undergo either active or sham stimulation for their first 24-hour EEG monitoring visit, and the opposite intervention on the second 24-hour EEG monitoring visit. | Device | Active tDCS, Sham tDCS |
Primary outcome
Measurement of seizure activity via electroencephalography (EEG)
Time frame: Measured for approximately 48 hours
Measurement of seizure activity will take place in two visits of 24-hour seizure monitoring. During these visits, the EEG will record seizure information including (1) number of seizures, (2) severity of seizures, and (3) latency of seizures between sessions of stimulation.
3 secondary outcomes
Subject self-report of seizure activity
Time frame: Measured for approximately 8 weeks.
Measurement of healthy subjects EEG changes
Time frame: Measured for approximately 2 hours
N-back memory and attention test
Time frame: Measured for approximately 2 hours
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 24 Apr 2020.
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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.
Felipe Fregni, MD, PhD, MPH principal investigator
Spaulding Rehabilitation Hospital (SRH)
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 and Seizures, run by Spaulding Rehabilitation Hospital 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 7 inclusion and 18 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 24 Apr 2020. 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. 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.
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?
Measurement of seizure activity via electroencephalography (EEG) (time frame: Measured for approximately 48 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 24 Apr 2020.