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

Not Applicable

• Conditions: G40.1; Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures

• Registration Number: DRKS00008953
• Lead Sponsor: Precisis AG

Brief Summary

This was a pilot study seeking to identify potential trends and effects of transcranial stimulation. Results support the argument that transcranial stimulation with the EASEE IB system is safe. From the data available there is a trend towards transcranial AC stimulation being better tolerable and more effective in reducing epileptic activity. However, further studies with a larger sample size are needed to confirm this trend.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-24
• Study Completion: 2017-12-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Difference in percent reduction in interictal epileptic discharges between AC and DC. <br>EEG data collected will be analysed statistically to ascertain whether AC and DC stimulation have different effects.<br><br>2. Difference in tolerability of stimulation AC vs. DC<br>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.<br><br>3. Effect on seizure frequency<br>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. <br>