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A Research Study to Evaluate the Effectiveness of a Novel Personalized Electrical Brain Stimulation for the Treatment of Drug-Resistant Focal Epilepsy

Therapeutic Efficacy of Multimodal Imaging-Guided Brain Network Modulation through Personalized, Multisession, High-density Transcranial Direct Current Stimulation in Drug-Resistant Focal Epilepsy: A Double-Blind Sham-Controlled Study - NIL

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061978
Enrollment
80
Registered
2024-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: G400- Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset

Interventions

Intervention1: Transcranial direct current stimulation (tDCS): Real tDCS protocol: Three cycles (one cycle per two months). Each cycle consisted of 10 sessions (2 weeks x five consecutive days) where

Sponsors

Dr. Suriya Prakash Muthukrishnan
Lead Sponsor
Dr Animesh Das
Collaborator
Dr Lalan Kumar
Collaborator
Dr Prashant Jauhari
Collaborator
Dr Ratna Sharma
Collaborator
Dr S Senthil Kumaran
Collaborator
Dr Sheffali Gulati
Collaborator
Dr Tapan Kumar Gandhi
Collaborator
Dr Vijayakumar
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Proven focal onset seizures H/o for at least 2 years refractory to antiepileptic drugs

Exclusion criteria

Exclusion criteria: Pseudoseizures Progressive brain disorders or systemic diseases other than epilepsy Genetic aetiology Patients with implants Change of AEDs during the course of the study Pregnancy

Design outcomes

Primary

MeasureTime frame
1. Continuous monitoring of seizure frequency through a seizure diary 2. Interictal discharge in EEG: 9 sessions (2 sessions - pre-intervention; 4 sessions – Intervention; 3 sessions – post-intervention) Timepoint: 1. Continuous monitoring of seizure frequency through a seizure diary 2. Interictal discharge in EEG (9 sessions): Two sessions – pre-intervention (Day 1 to Day 60) Four sessions – Intervention (Day 61 to Day 240) Three sessions – post-intervention (Day 241 to Day 420)

Secondary

MeasureTime frame
Quality of Life in Epilepsy Inventory: 9 sessions (2 sessions - pre-intervention; 4 sessions – Intervention; 3 sessions – post-intervention)Timepoint: Quality of Life in Epilepsy Inventory (9 sessions): Two sessions – pre-intervention (Day 1 to Day 60) Four sessions – Intervention (Day 61 to Day 240) Three sessions – post-intervention (Day 241 to Day 420)

Countries

India

Contacts

Public ContactSuriya Prakash Muthukrishnan

All India Institute of Medical Sciences

dr.suriyaprakash@aiims.edu9650812987

Outcome results

None listed

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