Transcutaneous Electrical Stimulation of Vagus Nerve Among Stroke survivors

Efficacy and safety of Transcutaneous Electrical Stimulation of Vagus Nerve in Upper Limb Motor Recovery Among Stroke survivors: A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078441

Enrollment

Registered

2024-12-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: G811- Spastic hemiplegia

Interventions

Intervention1: Vagus nerve stimulation using TENS: The Group A will get Vagus nerve stimulation using TENS with the clip electrodes placed at the Cymba conchae at the left ear 0.3ms pulses, 30Hz, inte

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age: 18 years and above. 2.Patients having an ischemic stroke for at least 3 months previously 3.No strict cut-offs will be required for baseline upper limb function as long as the 4.Participant could engage with the therapist and perform the limb movements.

Exclusion criteria

Exclusion criteria: 1.Patients having impairments of upper limb function other than those caused by stroke 2.Hemorrhagic Stroke 3.Patients having aphasia or cognitive difficulties severe enough to interfere with the informed consent process, task specific practice or communication of adverse events, 4.Pregnant or trying to get pregnant patients 5.Patients having a pacemaker or other implanted electrical device 6.Patients having severe spasticity (a Modified Ashworth Score12 =3). 7.Low hearth rate ( 8.Apraxia 9.Excessive pain in any joint of the paretic extremity 10.Advanced liver, kidney, cardiac, or pulmonary disease 11.History of significant alcohol or drug abuse 12.Depression or use of neuropsychotropic drugs such as antidepressants or benzodiazepines

Design outcomes

Primary

Measure	Time frame
Demographics, time since stroke, medication and vascular risk factors will be obtained from participants. Hospital records and imaging results will be viewed to record the size, location and precise date of the stroke. Two measures of upper limb movement and functional independence will be assessed: 1. Upper Limb Fugl-Meyer (UFM) 2. Action Recovery Arm Test (ARAT). Timepoint: These assessments will be performed at baseline and at the end of the intervention (3 weeks). To observe long-term effects, evaluation will be done at 6 weeks and 12 weeks after first intervention.	—

Measure

Time frame

Demographics, time since stroke, medication and vascular risk factors will be obtained from participants. Hospital records and imaging results will be viewed to record the size, location and precise date of the stroke. Two measures of upper limb movement and functional independence will be assessed: 1. Upper Limb Fugl-Meyer (UFM) 2. Action Recovery Arm Test (ARAT). Timepoint: These assessments will be performed at baseline and at the end of the intervention (3 weeks). To observe long-term effects, evaluation will be done at 6 weeks and 12 weeks after first intervention.

—

Secondary

Measure	Time frame
NATimepoint: NA	—

Countries

India

Contacts

Public ContactDr Sandip Dhole

AIIMS, Bibinagar

drsandipdhole@gmail.com9867927350

Outcome results

None listed

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