A randomized trial of electrical stimulation of the brain for management of psychogenic seizures
Not Applicable
- Conditions
- Health Condition 1: F445- Conversion disorder with seizuresor convulsions
- Registration Number
- CTRI/2024/01/061260
- Lead Sponsor
- ONE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Subjects with psychogenic non-epileptic seizures
1. Aged >18 years
2. Diagnosis of PNES by short term VEEG recording
3. =2 events/month.
Exclusion Criteria
1)Subjects with known epilepsy
2)Subjects with PNES who have significant intellectual disability
3)Severe psychiatric comorbidity and suicidal ideations
4)Pregnant women
5)Those with dementia, psychosis, delirium, scalp infections or lesions
6)Subjects with history of brain surgery or aneurysm clipping or electrical device implantation like pacemaker
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method defined as success if = 50% reduction in event frequency at end of one month compared to baseline. <br/ ><br>Timepoint: defined as success if = 50% reduction in event frequency at end of one month compared to baseline. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Absolute number of events/months at the end of 1,2 & 3 months expressed as median with IQR or mean with SD. Application of 1st sessions of tDCS is considered as day 1. After 30 days from the onset of tDCS patient first time followed and subsequently at 2nd and 3rd month; Safety parameters from the ADR and self-report questionnaire as proportions; Scores on HAM-A, HAM-D, BREF-QOL, QOLIE at the end of 1, 2 and 3 months as median with IQR. <br/ ><br>Timepoint: at end of 2nd & 3rd month