EASEE IB: Comparing the Effectiveness of Transcranial AC and DC Stimulation in Patients with Refractory Epilepsy

EASEE IB: Comparing the Effectiveness of Transcranial AC and DC Stimulation in Patients with Refractory Epilepsy - EASEE IB

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00008953

Enrollment

Registered

2015-08-24

Start date

2015-12-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G40.1

Interventions

Group 1: Test Session 1: 2.5-hour EEG recording, 20-minute active AC stimulation (alternating current stimulation) and 2.5-hour follow-up EEG evaluation Test Session 2: 2.5-hour EEG recording, 100-mi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Diagnosis of focal epilepsy based on patient history (semiology) and additional supportive data from technical investigations - Pharmacoresistance to more than 2 antiepileptic drugs at maximal tolerated dosages - Stable medication regime for 14 days prior to the first session and during the study period - Evidence for interictal epileptiform discharges (spikes/sharp waves) obtained with standard 10-20-electrodes at a minimum rate of 15/h - Evidence for a cortical seizure generator (based on EEG or imaging) - Informed consent to participate in this study

Exclusion criteria

Exclusion criteria: - History of brain surgery or skull fracture - Psychiatric disease - Mental impairment (IQ <85) - Intracerebral implants - Chronic or active dermatological conditions of the scalp - Previous history of substance abuse - Pregnancy / period of breastfeeding

Design outcomes

Primary

Measure	Time frame
What? Percent reduction in interictal epileptic discharge after stimulation vs. baseline When? Baseline and after stimulation (2,5-hour EEG Recordings) How? EEG Recordings will be evaluated by two independent assessors	—

Secondary

Measure	Time frame
1. Difference in percent reduction in interictal epileptic discharges between AC and DC. EEG data collected will be analysed statistically to ascertain whether AC and DC stimulation have different effects. 2. Difference in tolerability of stimulation AC vs. DC Subjects will be asked qualitative questions during stimulation about their sensations. The results will be recorded and analysed to reveal if there is a difference between AC and DC in terms of tolerability. 3. Effect on seizure frequency Seizure frequency will be monitored in the time period 4 weeks before stimulation and 4 weeks after stimulation. The subjects collect the data in their seizure diaries and this will be transferred to the CRF. The seizure frequency after stimulation will then be compared to the seizure freqeuncy before stimulation.	—

Measure

Time frame

1. Difference in percent reduction in interictal epileptic discharges between AC and DC. EEG data collected will be analysed statistically to ascertain whether AC and DC stimulation have different effects. 2. Difference in tolerability of stimulation AC vs. DC Subjects will be asked qualitative questions during stimulation about their sensations. The results will be recorded and analysed to reveal if there is a difference between AC and DC in terms of tolerability. 3. Effect on seizure frequency Seizure frequency will be monitored in the time period 4 weeks before stimulation and 4 weeks after stimulation. The subjects collect the data in their seizure diaries and this will be transferred to the CRF. The seizure frequency after stimulation will then be compared to the seizure freqeuncy before stimulation.

—

Countries

Germany

Contacts

Public ContactKinga Egressy

Precisis AG

k.egressy@precisis.de+49 6221 6559325

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026