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

NCT01415362 | Completed

• 1 other identifier: 2010-p-000289
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Seizures

Keywords

transcranial direct current stimulation; electroencephalography

Outcome Measures

Primary Outcomes (1)

• 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 for approximately 48 hours

Secondary Outcomes (3)

• Subject self-report of seizure activity

  Measured for approximately 8 weeks.

• Measurement of healthy subjects EEG changes

  Measured for approximately 2 hours

• N-back memory and attention test

  Measured for approximately 2 hours

Study Arms (2)

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.

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.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

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.

Also known as: low intensity 1x1 direct current stimulator

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• \- Healthy subjects age 18 and older
• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Felipe Fregni, MD, PhD, MPH

  Spaulding Rehabilitation Hospital (SRH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: August 11, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (1)