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A trial to compare online doctor consultation versus hospital visit consultation for children with infantile spasms (a type of difficult infantile epilepsy)

Comparison of telemedicine versus in-person follow-Up in children with infantile epileptic spasms syndrome (IESS): A Randomized controlled trial (Tele-IESS Trial) - Tele-IESS Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097463
Enrollment
146
Registered
2025-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: G404- Other generalized epilepsy and epileptic syndromes

Interventions

Intervention1: Telemedicine: Synchronus (audio-visual) form of telemedicine will be used for remote follow-up Control Intervention1: In-person follow-up: In-person follow-up as usual care will be cont

Sponsors

Indian Council of Medical Research (ICMR)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of IESS as per ILAE 2. Newly started on ACTH therapy. 3. Parents or caregivers willing to participate and provide informed consent. 4. Access to a smartphone/internet 5. Resides more than 10km distance from our institute

Exclusion criteria

Exclusion criteria: 1. Prior history of ACTH or steroid therapy for epilepsy. 2. Structural brain abnormalities requiring urgent neurosurgical intervention. 3. Severe comorbidities needing hospital admission (e.g., sepsis, metabolic crisis). 4. Parents are unlikely to adhere to a follow-up schedule.

Design outcomes

Primary

MeasureTime frame
Epileptic spasms-free rate, as reported by parents at 1, 2, and 6 weeks and validated by EEG resolution using BASED scoring at 6 weeks post-treatment.Timepoint: Outcomes measured at 1, 2, and 6 weeks—

Secondary

MeasureTime frame
To assess caregiver burden (Zarit Burden Interview) and parental QoL (EQ-5D-5L) at 2- and 6-weeks post-treatment, comparing TMF and IPF groups.Timepoint: Zarit Burden Interview scores at baseline, 2 and 6 weeks post-treatment and parental QoL at baseline and 6 weeks;To measure adherence to ACTH therapy using MARS-5 at 6 weeks post-treatment for both groups.Timepoint: At six weeks;To analyze telemedicine follow-up cost-effectiveness versus in-person follow-up by assessing direct/indirect costs and identifying implementation barriers through qualitative interviews at study completion.Timepoint: Assessed over completion of 6 weeks—

Countries

India

Contacts

Public ContactJitendra Kumar Sahu

Postgraduate Institute of Medical Education and Research, Chandigarh

jsh2003@gmail.com7087009202

Outcome results

None listed

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