Transcranial Direct Current to Treat Epilepsy at Home

NCT04309812 | Active Not Recruiting FDA Device

• 1 other identifier: IRB# 47711
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

This is a placebo-controlled study of feasibility and potential effectiveness of transcranial direct current stimulation (tDCS) in the home environment to reduce seizures and EEG spikes.

Conditions

Epilepsies, Partial

Outcome Measures

Primary Outcomes (3)

• Change in seizures per month

  Number of seizures recorded in the patient diary

  Within 1 week of end of the SHORT treatment and within 1 week of end of the LONG treatment

• Change in seizures per month

  Number of seizures recorded in the patient diary

  Recorded at time of study entry (BASELINE) and within 1 week of end of the SHORT treatment

• Change in seizures per month

  Number of seizures recorded in the patient diary

  Recorded at time of study entry (BASELINE) and within 1 week of end of the LONG treatment

Secondary Outcomes (3)

• Change in severity of seizures

  Within 1 week of end of the SHORT treatment and within 1 week of end of the LONG treatment

• Change in duration of seizures

  Within 1 week of end of the SHORT treatment and within 1 week of end of the LONG treatment

• Number of epileptiform EEG spikes

  Within 1 week of end of the SHORT treatment and within 1 week of end of the LONG treatment

Study Arms (2)

Short Stimulation

ACTIVE COMPARATOR

1 minute duration of stimulation per day for 30 days

Device: transcranial direct current stimulation (tDCS)

Long Stimulation

EXPERIMENTAL

30 minutes duration of stimulation per day for 30 days

Device: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS) DEVICE

Electrical stimulation of scalp over a seizure focus

Long Stimulation; Short Stimulation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Stanford Hospital

Stanford, California, 94305-5235, United States

Location

Stanford University School of Medicine

Stanford, California, 94305-5235, United States

Location

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maslah Saul MD Professor of Neurology

Model Details: Randomized to SHORT or LONG dose tDCS as first treatment

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 16, 2020
• Study Start: May 26, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)