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NCT05673915 Clinical Trial

Study of Transcranial Direct Current Stimulation to Treat Epilepsy

Focal Epilepsy Clinical Trial

Official title:
Pilot Study of Transcranial Direct Current Stimulation (tDCS) to Treat Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05673915
Other study ID # 22-008944
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 12, 2023
Est. completion date February 2025

Study information
Verified date April 2024
Source Mayo Clinic
Contact Iesha Abbajebel
Phone 507-422-9975
Email abbajebel.iesha@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date February 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS)
Stimulation setting 0.1 mA daily for a 2-month period. Each daily treatment will last for approximately 30 minutes.
• ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)
Stimulation setting 2.0 mA daily for a 2-month period. A Each daily treatment will last for approximately 30 minutes.

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Seizure Count Number of seizures experienced by subjects as determined by self-reported seizure diary 2 months
Secondary EEG interictal discharge frequency Number of interictal epileptiform discharges observed on electroencephalogram (EEG) 2 months
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