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Smart device for uncontrolled epilepsy monitoring & treatment

Smart tVNS: A device that uses closed-loop technology and machine learning to optimise non-invasive transcutaneous vagal nerve stimulation (tVNS) for refractory epilepsy monitoring and treatmentâ??.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/037964
Enrollment
10
Registered
2021-11-11
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: tVNS stimulation: Patients with refractory epilepsy with daily seizures will be recruited and connected to a device which has integrated ambulatory EEG and tVNS. The base tVNS stimulati

Sponsors

DAEPARTMENT OF SCIENCE AND TECHNOLOGY
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Refractory epilepsy 2) Seizure frequency of at least 1 per day in the preceding 1month 3) Cooperative for undergoing the ambulatory EEG and tVNS stimulation 4) Underwent VEEG and had identified ictal EEG pattern

Exclusion criteria

Exclusion criteria: 1) Uncooperative patients 2) Pregnancy 3) Lack of consent

Design outcomes

Primary

MeasureTime frame
The baseline mean seizure frequency per week, 1 week prior to the admission will be compared to the seizure frequency after the admission while on add on treatment with tVNS after a week for in patients and after at 12- 20 weeks for outpatientsTimepoint: Baseline mean seizure frequency per week vs 1 week (for inpatients) or 12- 20 weeks (for outpatients)

Secondary

MeasureTime frame
1) tolerability 2) side effectsTimepoint: 1week (inpatients) 12-20 weeks(outpatients)

Countries

India

Contacts

Public ContactRavindranadh Chowdary Mundlamuri

NIMHANS

mundlamuri.ravi@yahoo.com9008219433

Outcome results

None listed

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