Clinical trial NCT01415362: Closed-loop System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy
Official title: Development of a Closed-loop Detect-and-treat System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Seizures
Keywords: transcranial direct current stimulation
electroencephalography
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility 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

Primary outcomes:
measure: Measurement of seizure activity via electroencephalography (EEG)
timeFrame: Measured for approximately 48 hours
Secondary outcomes:
measure: Subject self-report of seizure activity
timeFrame: Measured for approximately 8 weeks.
measure: Measurement of healthy subjects EEG changes
timeFrame: Measured for approximately 2 hours
measure: N-back memory and attention test
timeFrame: Measured for approximately 2 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital (SRH)
name: Felipe Fregni, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: