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

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.

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:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Rehabilitation Seizures

U.S. FDA Resources

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.

Estimated Enrollment:	16
Study Start Date:	July 2011
Estimated Primary Completion Date:	July 2012 (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

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:	No

Criteria

Inclusion Criteria

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

Contacts and Locations

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

Locations

United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114

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:	June 18, 2012
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 May 16, 2013