Closed-loop System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Spaulding Rehabilitation Hospital
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01415362
First received: July 26, 2011
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

In this pilot study, the researchers are investigating the feasibility of a closed-loop electroencephalography (EEG) / transcranial direct current stimulation (tDCS) system for treatment of epilepsy. They are looking 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 requires 5 visits over the course of approximately 8 weeks. Each visit will be separated by at least 2 weeks. Two of the visits will be 24-hour EEG monitoring sessions. During these two sessions, the EEG and tDCS will be hooked into a closed loop system, such that when seizure activity is detected, the tDCS will be triggered to deliver stimulation. Subject will receive active stimulation or sham stimulation sessions during the first 24-hour visit, and the opposite during the second. The subjects will be 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.


Condition Intervention Phase
Epilepsy
Seizures
Device: Transcranial Direct Current Stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Development of a Closed-loop Detect-and-treat System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy

Resource links provided by NLM:


Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Measurement of seizure activity via electroencephalography (EEG) [ Time Frame: Measured for approximately 48 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Subject self-report of seizure activity [ Time Frame: Measured for approximately 8 weeks. ] [ Designated as safety issue: No ]
    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.

  • Measurement of healthy subjects EEG changes [ Time Frame: Measured for approximately 2 hours ] [ Designated as safety issue: No ]
    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)

  • N-back memory and attention test [ Time Frame: Measured for approximately 2 hours ] [ Designated as safety issue: No ]
    We will assess working memory and attention in healthy individuals using the n-back test, assessing changes from pre- to post-tDCS


Estimated Enrollment: 22
Study Start Date: July 2011
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active tDCS
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.
Device: Transcranial Direct Current Stimulation

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.

Other Name: low intensity 1x1 direct current stimulator
Sham Comparator: Sham tDCS
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.
Device: Transcranial Direct Current Stimulation

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.

Other Name: low intensity 1x1 direct current stimulator

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (Epileptics)

  • 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.

Exclusion Criteria

  • 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
    • implanted brain medical devices
  • Pregnancy
  • Any implanted electrical medical device, including pacers and implanted cardiac defibrillators

Inclusion criteria (Healthy Subjects)

- Healthy subjects age 18 and older

Exclusion criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415362

Contacts
Contact: Felipe Fregni, MD, PhD, MPH 617-952-6156 ffregni@partners.org
Contact: Sarah Daly, BS 617-952-6153 sdaly1@partners.org

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Felipe Fregni, MD, PhD, MPH    617-952-6156    ffregni@partners.org   
Contact: Sarah Daly, BS    617-952-6153    sdaly1@partners.org   
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Felipe Fregni, MD, PhD, MPH Spaulding Rehabilitation Hospital (SRH)
  More Information

No publications provided

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01415362     History of Changes
Other Study ID Numbers: 2010-p-000289
Study First Received: July 26, 2011
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
transcranial direct current stimulation
electroencephalography

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014