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

Primary Purpose

Epilepsy, Seizures

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial Direct Current Stimulation

About this trial

This is an interventional prevention trial for Epilepsy focused on measuring transcranial direct current stimulation, electroencephalography

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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)

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

Full Information

NCT ID

NCT01415362

First Posted

July 26, 2011

Last Updated

April 23, 2020

Sponsor

Spaulding Rehabilitation Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01415362

Brief Title

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

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Seizures

Keywords

transcranial direct current stimulation, electroencephalography

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Sham tDCS

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation

Other Intervention Name(s)

low intensity 1x1 direct current stimulator

Intervention Description

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.

Primary Outcome Measure Information:

Title

Measurement of seizure activity via electroencephalography (EEG)

Description

Time Frame

Measured for approximately 48 hours

Secondary Outcome Measure Information:

Title

Subject self-report of seizure activity

Description

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.

Time Frame

Measured for approximately 8 weeks.

Title

Measurement of healthy subjects EEG changes

Description

Time Frame

Measured for approximately 2 hours

Title

N-back memory and attention test

Description

We will assess working memory and attention in healthy individuals using the n-back test, assessing changes from pre- to post-tDCS

Time Frame

Measured for approximately 2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felipe Fregni, MD, PhD, MPH

Organizational Affiliation

Spaulding Rehabilitation Hospital (SRH)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Spaulding Rehabilitation Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

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

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