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Safety and usefulness of application of direct painless electrical current to brain in patients with pseudo seizure.

Safety and efficacy of transcranial direct current stimulation (tDCS) as add on therapy in reducing event frequency in subjects with psychogenic non-epileptic seizures: A randomized double blind sham controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027669
Enrollment
36
Registered
2020-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: F445- Conversion disorder with seizuresor convulsions

Interventions

Intervention1: TRANSCRANIAL DIRECT CURRENT STIMULATION VS SHAM STIMULATION: Transcranial direct current stimulation (tDCS) will be administered using a DC stimulator Soterix medical, U.S. A. We will u

Sponsors

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION amp RESEARCH PUDUCHERRY
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Our study include two sets of patients i.e 1.clinically established PNES &; 2.Documented PNES, having aged >18 years and >=2 events/month. According to ILAE (International League Against Epilepsy), Clinically Established PNES:These are those patients, who are diagnosed by an experienced clinician(in seizure disorder) on the basis of video or person that showing semiology typical of PNES. Documented PNES are those patients diagnosed by experienced clinician on the basis of semiology typical of PNES in video EEG.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
To determine the efficacy of transcranial direct current stimulation compared to sham stimulation in increasing the proportion of subjects achieving â?¥50% reduction in event frequency/month at the end of 1st month of treatment compared to baseline in subjects with psychogenic non epileptic seizuresTimepoint: 1 month—

Secondary

MeasureTime frame
1.To determine the safety of tDCS in this subject population. 2.To determine if the effects of tDCS on event frequency at the end of 2nd and 3rd month after treatment. 3.To determine effects of tDCS on measures of psychopathology (HAM-A and HAM-D) and quality of life measures (WHO BREF-QOL and QOLIE) 4.To explore factors associated with response to tDCS such as imaging abnormalities 5.To see the effect of tDCS on the EEG power spectrum Timepoint: 2nd & 3rd month—

Countries

India

Contacts

Public ContactDrRAJESWARI AGHORAM

JIPMER

rajeswari.a@jipmer.edu.in0413-2297285

Outcome results

None listed

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