Back to resultsStudy of Transcranial Direct Current Stimulation to Treat Epilepsy
Primary Purpose
Focal Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS)
ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)
Sponsored by
About this trial
This is an interventional treatment trial for Focal Epilepsy
Eligibility Criteria
Inclusion Criteria Clinical diagnosis of focal epilepsy. Estimated to have at least 2 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.
Sites / Locations
- Mayo Clinic MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
tDCS Treatment A (Low Amplitude)
tDCS Treatment B (High Amplitude)
Arm Description
Subjects with focal epilepsy that is not well-controlled on anti-seizure medications will receive 2 different treatments periods, each lasting 2 months, of transcranial direct current stimulation (tDCS). The initial treatment stimulation will be completed during the first 2-months.
Subjects with focal epilepsy that is not well-controlled on anti-seizure medications will receive 2 different treatments periods, each lasting 2 months, of transcranial direct current stimulation (tDCS). The last treatment stimulation will be completed during the following 2-months.
Outcomes
Primary Outcome Measures
Seizure Count
Number of seizures experienced by subjects as determined by self-reported seizure diary
Secondary Outcome Measures
EEG interictal discharge frequency
Number of interictal epileptiform discharges observed on electroencephalogram (EEG)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05673915
Brief Title
Study of Transcranial Direct Current Stimulation to Treat Epilepsy
Official Title
Pilot Study of Transcranial Direct Current Stimulation (tDCS) to Treat Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to see to what extent electrical stimulation applied to the scalp (transcranial direct current stimulation or tDCS) can reduce the number and intensity of epileptic seizures.
Detailed Description
tDCS for treatment of epilepsy has been studied previously with results suggesting that it can lead to a notable seizure reduction for a limited time period after the cessation of stimulation, e.g., about one month. Here, we assess further aspects of tDCS treatment protocols, including the feasibility and safety of at-home use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tDCS Treatment A (Low Amplitude)
Arm Type
Experimental
Arm Description
Subjects with focal epilepsy that is not well-controlled on anti-seizure medications will receive 2 different treatments periods, each lasting 2 months, of transcranial direct current stimulation (tDCS). The initial treatment stimulation will be completed during the first 2-months.
Arm Title
tDCS Treatment B (High Amplitude)
Arm Type
Experimental
Arm Description
Subjects with focal epilepsy that is not well-controlled on anti-seizure medications will receive 2 different treatments periods, each lasting 2 months, of transcranial direct current stimulation (tDCS). The last treatment stimulation will be completed during the following 2-months.
Intervention Type
Device
Intervention Name(s)
ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS)
Intervention Description
Stimulation setting 0.1 mA daily for a 2-month period. Each daily treatment will last for approximately 30 minutes.
Intervention Type
Device
Intervention Name(s)
ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)
Intervention Description
Stimulation setting 2.0 mA daily for a 2-month period. A Each daily treatment will last for approximately 30 minutes.
Primary Outcome Measure Information:
Title
Seizure Count
Description
Number of seizures experienced by subjects as determined by self-reported seizure diary
Time Frame
2 months
Secondary Outcome Measure Information:
Title
EEG interictal discharge frequency
Description
Number of interictal epileptiform discharges observed on electroencephalogram (EEG)
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Clinical diagnosis of focal epilepsy.
Estimated to have at least 2 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iesha Abbajebel
Phone
507-422-9975
Email
abbajebel.iesha@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julianna Ethridge
Email
ethridge.julianna@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Lundstrom, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Study of Transcranial Direct Current Stimulation to Treat Epilepsy
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