Health TrialsbyHealthPanel

Study of Transcranial Direct Current Stimulation to Treat Epilepsy

ConditionsFocal EpilepsyGeneralized Onset EpilepsySleep-related Epileptic Encephalopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of generalized onset or focal epilepsy or sleep-related epileptic encephalopathy.

Estimated to have at least 2 countable seizures per month or spike-wave index ≥50%.

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).

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS)

    Device

    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)

    Device

    Stimulation setting 2.0 mA daily for a 2-month period. A Each daily treatment will last for approximately 30 minutes.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: tDCS Treatment A (Low Amplitude)Experimental treatment 1 intervention
Group B: tDCS Treatment B (High Amplitude)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Seizure Count

Number of seizures experienced by subjects as determined by self-reported seizure diary

Time frame
2 months

Secondary outcomes

1

EEG interictal discharge frequency

Number of interictal epileptiform discharges observed on electroencephalogram (EEG)

Time frame
2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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