Transcutaneous auricular vagus nerve stimulation with task-oriented training for recovery of upper limb motor function in patients with stroke : a fNIRS study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400085163

Enrollment

Unknown

Registered

2024-05-31

Start date

2024-06-01

Completion date

Unknown

Last updated

2024-06-03

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

Conditions

stroke

Interventions

Treatment Group:Transcutaneous vagus nerve stimulation (taVNS) was administered concurrently with 30 minutes of task-oriented training and 30 minutes of routine rehabilitation therapy for stroke patie

Control Group:The sham stimulation uses a subthreshold stimulation intensity.

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? First onset of unilateral supratentorial cerebral infarction or cerebral hemorrhage, confirmed by CT or MRI;? Unilateral limb hemiplegia; ? From one week to six months after onset; ?FMA-UE scores were in the range of 20 to 50 points; ? Aged between 18 and 80 years old;? Ability to comprehend the purpose of the research, willingness to cooperate with the study, and capacity to provide informed consent by signing the necessary documentation.

Exclusion criteria

Exclusion criteria: The presence of implantable electronic devices, intracranial vascular clips or other electronic activation/sensitive devices; (2) Skin lesions that may interfere with stimulation or stimulation of equipment, such as scar tissue, skin damage, etc.; ? There are serious cardiovascular system diseases, or lung, liver, kidney insufficiency; ? Vagus nerve surgery or vagus nerve injury; (5) There are other causes of upper limb dysfunction other than stroke; (6) Taking antidepressants or benzodiazepines; (7) People who have had Botox injections in the past 3 months; (8) Resting heart rate below 60 beats/min.

Design outcomes

Primary

Measure	Time frame
Task-related HbO2 concentration changes (changes in cerebral blood flow).;Heart rate variability;Motor-evoked potentials, MEP;Fugl-Meyer Assessment-Upper Extremity;Action Research Arm Test;Fugl-Meyer Test for Upper Extremity (FTHUE) - Hong Kong Version;Fatigue Severity Scale;	—

Secondary

Measure	Time frame
Montreal Cognitive Assessment;Cognitive Assessment Scale for Stroke Patients;Modified Barthel Index;	—

Countries

China

Contacts

Public ContactZhongli Jiang

Department of Rehabilitation Medicine, Sir Run Run Hospital, Nanjing Medical University

jiangzhongli@njmu.edu.cn+86 138 5189 8370

Outcome results

None listed

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