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Transcranial Direct Current to Treat Epilepsy at Home

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04309812
Recruitment Status : Enrolling by invitation
First Posted : March 16, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Robert S. Fisher, M.D., Ph.D., Stanford University

Brief Summary:
This is a placebo-controlled study of the effectiveness of transcranial direct current stimulation (tDCS) at home to reduce seizures and EEG spikes.

Condition or disease Intervention/treatment Phase
Epilepsies, Partial Device: transcranial direct current stimulation (tDCS) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized to SHORT or LONG dose tDCS as first treatment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Since the subject sets the stimulation settings for each day of treatment, it is not possible to employ a full placebo with this device. We will inform the subjects that we are uncertain whether short stimulation of 1 minute is less effective than is longer stimulation of 30 minutes, which is a true statement according to our current state of knowledge. We will use a balanced deck of randomized cards setting the initial treatment arm as SHORT in 15 cases and LONG in 15 cases.
Primary Purpose: Treatment
Official Title: Transcranial Direct Current to Treat Epilepsy at Home
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Active Comparator: Short Stimulation
1 minute duration of stimulation per day for 30 days
Device: transcranial direct current stimulation (tDCS)
Electrical stimulation of scalp over a seizure focus

Experimental: Long Stimulation
30 minutes duration of stimulation per day for 30 days
Device: transcranial direct current stimulation (tDCS)
Electrical stimulation of scalp over a seizure focus




Primary Outcome Measures :
  1. Change in seizures per month [ Time Frame: Within 1 week of end of the SHORT treatment and within 1 week of end of the LONG treatment ]
    Number of seizures recorded in the patient diary

  2. Change in seizures per month [ Time Frame: Recorded at time of study entry (BASELINE) and within 1 week of end of the SHORT treatment ]
    Number of seizures recorded in the patient diary

  3. Change in seizures per month [ Time Frame: Recorded at time of study entry (BASELINE) and within 1 week of end of the LONG treatment ]
    Number of seizures recorded in the patient diary


Secondary Outcome Measures :
  1. Change in severity of seizures [ Time Frame: Within 1 week of end of the SHORT treatment and within 1 week of end of the LONG treatment ]
    Severity of seizures recorded in the patient diary

  2. Change in duration of seizures [ Time Frame: Within 1 week of end of the SHORT treatment and within 1 week of end of the LONG treatment ]
    Duration of seizures as recorded in the patient diary

  3. Number of epileptiform EEG spikes [ Time Frame: Within 1 week of end of the SHORT treatment and within 1 week of end of the LONG treatment ]
    Count by blinded evaluator on EEGs before and after tDCS



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-100, inclusive.
  • Has a clinical diagnosis of epilepsy
  • Has at least 4 countable seizures per month
  • Has not had control with at least 2 anti-seizure medicines
  • Able to maintain a constant medication for duration of the study (rescue meds allowed)
  • Subject or legally authorized representative is able to understand consent and keep a seizure diary in English

Exclusion Criteria:

  • A disease likely to progress over course of the study
  • Psychogenic non-epileptic seizures
  • Suicide attempt or psychiatric hospitalization past 2 years
  • A skin condition interfering with scalp electrodes or allergy to silver
  • Women will verify not pregnant, and if applicable, have a serum pregnancy test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04309812


Locations
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United States, California
Stanford Hospital
Stanford, California, United States, 94305-5235
Stanford University School of Medicine
Stanford, California, United States, 94305-5235
Sponsors and Collaborators
Stanford University
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Responsible Party: Robert S. Fisher, M.D., Ph.D., Maslah Saul MD Professor of Neurology, Stanford University
ClinicalTrials.gov Identifier: NCT04309812    
Other Study ID Numbers: IRB# 47711
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases