Physiological effect of therapeutic nerve stimulation in Healthy Human Participants

Optimising Percutaneous Trigeminal and Vagal Intermittent Electro-Therapeutic Nerve Stimulation in Parkinson’s Disease (OPTIoNS-PD) - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066254

Enrollment

Registered

2024-04-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

None listed

Interventions

Intervention1: Transauricular Vagus Nerve Stimulation (tVNS) and Trigeminal Nerve Stimulation (TNS): Portable Transcutaneous Electrical Stimulation Device programmed for tVNS and TNS Active stimulatio

Eligibility

Inclusion criteria

Inclusion criteria: Consenting healthy (18-75 years)

Exclusion criteria

Exclusion criteria: 1. Seizure history. 2. History of neurological diseases or severe systemic diseases. 3. Those with a contraindication for TMS such as metallic implants or implanted permanent pacemaker

Design outcomes

Primary

Measure	Time frame
ECG – Heart rate variability is a measure of cardiac vagus nerve activation. Long rhythm lead ECG will be performed to assess the safety of the device.Timepoint: Before and after stimulation	—

Secondary

Measure	Time frame
Transcranial magnetic Stimulation (TMS) experimental paradigms- Several standard electrophysiological paradigms will be tested to explore the cortical network changes after VNS/ TNS. The paradigms are SICI, LICI and (ICF). Timepoint: Before and after stimulation	—

Countries

India

Contacts

Public ContactDr Supriyo Choudhury

Institute of Neurosciences, Kolkata

choudhurydrsupriyo@gmail.com9433106238

Outcome results