To see whether epilepsy surgery is better than standard medical therapy in terms of seizure freedom, rate of Psychogenic non-epileptic seizures (PNES), and quality of life in patients of coexisting Psychogenic non-epileptic seizures with drug-resistant epilepsy.

Management conundrum for coexisting Drug-resistant epilepsy with psychogenic non-epileptic seizures: A Randomized Controlled Trial - Drug Resistant epilepsy,PNES

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/02/040381

Enrollment

128

Registered

2022-02-17

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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

Conditions

Health Condition 1: G408- Other epilepsy and recurrent seizures

Interventions

Intervention1: Epilepsy Surgery group: Surgery will be performed with-in 2 months of randmization Control Intervention1: Continue Anti-seizure drugs group: Patients will be on the same anti-seizure dr

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age between 18-65 years and both gender will be included. 2.Will be able to give written informed consent for the participation and follow-up of the study. 3.Patients with DRE and PNES will be diagnosed by the experienced neurologist, epilepsy specialist and long term VEEG monitoring 4.DRE with PNES patients will have dual diagnosis of non-epileptic seizures and epileptiform discharges. 5.Will be cleared from the multidisciplinary epilepsy surgery case conference meeting. 6.Will be able to complete seizure diaries and complete regularly and questionnaires/scales. 7.Willing to undergo CBT and meditation based yoga intervention, counselling for 10 weeks (weekly). 8.Not enrolled for the CBT and meditation based yoga intervention since in last six months.

Exclusion criteria

Exclusion criteria: 1.Patients have other psychiatric disorders like schizophrenia, mood disorder, anxiety disorders, and psychosis. 2.Patients who scored severe and very severe depression score on Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)/ Hamiltonâ??s depression rating scale (HDRS). 3. Patients with metabolic abnormality, cardiac abnormality, renal failure and respiratory disease. 4.Not consenting patient for the participation and follow-up. 5.Patients will not having the alcohol dependence, smoking etc.

Design outcomes

Primary

Measure	Time frame
Primary outcome: This study would reveal the impact of CBT, counseling, and meditation-based yoga, in terms of seizure outcome and changes in seizure frequency over a period of 12 months in coexisting dual diagnosed (DRE with PNES) patients in both groups i.e. epilepsy surgery and usual Anti-seizures medications (ASMs) group. Timepoint: Baseline (T0), after 10 weeks of Phase-I intervention(T1), Post-intervention of phase-II at 6 months (T2) and 12 months (T3)	—

Measure

Time frame

Primary outcome: This study would reveal the impact of CBT, counseling, and meditation-based yoga, in terms of seizure outcome and changes in seizure frequency over a period of 12 months in coexisting dual diagnosed (DRE with PNES) patients in both groups i.e. epilepsy surgery and usual Anti-seizures medications (ASMs) group. Timepoint: Baseline (T0), after 10 weeks of Phase-I intervention(T1), Post-intervention of phase-II at 6 months (T2) and 12 months (T3)

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Secondary

Measure	Time frame
Changes in seizure severity, anxiety, depression, emotional behavior, quality of life, and cessation of PNES,Changes in functional connectivity, changes in epigenetics and metabolomics profile in these patients of Drug-resistant epilepsy with psychogenic non-epileptic seizureTimepoint: Baseline (T0), Before randomization (T1)-Phase-I intervention, Post intervention of phase-II at 6 months (T2) and 12 months (T3)	—

Measure

Time frame

Changes in seizure severity, anxiety, depression, emotional behavior, quality of life, and cessation of PNES,Changes in functional connectivity, changes in epigenetics and metabolomics profile in these patients of Drug-resistant epilepsy with psychogenic non-epileptic seizureTimepoint: Baseline (T0), Before randomization (T1)-Phase-I intervention, Post intervention of phase-II at 6 months (T2) and 12 months (T3)

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Countries

India

Contacts

Public ContactDr Manjari Tripathi

All India Institute of Medical Sciences, New Delhi

mtripathiaiims@gmail.com

Outcome results

None listed

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