NCT07629687

Brief Summary

This randomized controlled trial is conducted to determine the effects of transcutaneous auricular Vagus nerve stimulation (taVNS) on postural control in stroke patients (e.g., improvements in balance, mobility, and functional stability) and to evaluate the effects of taVNS on autonomic nervous system responses in stroke patients (e.g., changes in heart rate variability, blood pressure variability, skin conductance, and temperature).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable stroke

Timeline
5mo left

Started May 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
May 2026Nov 2026

Study Start

First participant enrolled

May 20, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2026

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Stroke

Keywords

Stroke rehabilitationTranscutaneous auricular vagus nerve stimulationPostural controlBalanceAutonomic functions

Outcome Measures

Primary Outcomes (7)

  • Berg Balance Scale (BBS)

    A clinical tool used to assess static and dynamic balance through 14 functional tasks. Tasks include sitting, standing, reaching, turning, and single-leg stance. It evaluates a person's ability to maintain balance during common daily activities and helps determine the risk of falls, especially in stroke patients and older adults. Scoring: Each item is scored from 0 to 4 (maximum score: 56) * Low fall risk: 41-56 * Moderate fall risk: 21-40 * High fall risk: 0-20

    4 Weeks

  • Timed Up and Go Test (TUG)

    A simple test used to assess mobility, balance, walking ability, and fall risk. The participant is timed while standing up from a chair, walking 3 meters, turning around, walking back, and sitting down. Scoring: Time recorded in seconds * \<10 sec: Normal mobility * 10-20 sec: Good mobility, mostly independent * \>20 sec: Limited mobility, may require assistance

    4 Weeks

  • Postural Assessment Scale for Stroke Patients (PASS)

    A stroke-specific tool used to assess postural control in lying, sitting, and standing positions. It includes 12 items that evaluate the ability to maintain or change postures. Scoring: Each item scored 0-3 (Total score: 36) Higher scores indicate better postural control.

    4 Weeks

  • Fugl-Meyer Assessment - Lower Extremity (FMA-LE)

    A quantitative measure to assess motor recovery of the lower extremities in post-stroke patients. Evaluates reflexes, movement, coordination, and joint function. Scoring: Each item scored on a 3-point scale (0 = cannot perform, 2 = performs fully) • Maximum score: 34 for lower extremity

    4 Weeks

  • Heart Rate Variability (HRV)

    A measure of the variation in time between heartbeats, reflecting autonomic nervous system activity, especially parasympathetic function. Scoring: Time-domain and frequency-domain indices (e.g., RMSSD, LF/HF ratio) Higher HRV = better autonomic flexibility.

    4 Weeks

  • Blood Pressure Variability (BPV)

    Evaluates variations in blood pressure over time, indicating autonomic regulation and cardiovascular stability. Scoring: Standard deviation (SD), coefficient of variation (CV), or spectral analysis • Abnormal variability may reflect autonomic dysfunction

    4 Weeks

  • Skin Conductance and Skin Temperature

    Measures sweat gland activity and peripheral temperature, indicating sympathetic nervous system activity.• Increased skin conductance = higher sympathetic arousal • Changes in skin temperature may reflect vasoconstriction/dilation

    4 Weeks

Study Arms (2)

Vagus Nerve Stimulation + Balance Training

EXPERIMENTAL

Participants in the experimental group will receive transcutaneous auricular vagus nerve stimulation (taVNS) administered according to standardized clinical protocols. No intervention is provided at baseline, aside from initial assessments. During Weeks 1 and 2, taVNS will be applied daily or as per a specified schedule. The stimulation parameters include: application at the auricular site (such as the tragus), with a frequency of 25 Hz, pulse width of 250 µs, and intensity adjusted to individual tolerance, not exceeding 6 mA. Each session will last for 30 minutes. The same taVNS protocol continues through Weeks 3 and 4. This group will not perform physical balance exercises during the taVNS phase, focusing solely on neuromodulation through vagus nerve stimulation.

Other: Vagus Nerve Stimulation + Balance Training Group

Balance Training

ACTIVE COMPARATOR

Participants in the control group will also undergo baseline assessments without intervention. During Weeks 1 and 2, they will participate in daily or scheduled 30-minute balance training sessions, consisting of 14 basic exercises such as sit-to-stand, tandem stance, and single-leg stance. These exercises are designed to improve static and dynamic balance, and are tailored to the individual's ability and safety level. In Weeks 3 and 4, the balance training progresses in difficulty. This includes increasing repetitions or duration, adding dual-task challenges (like cognitive tasks while balancing), and incorporating tools like foam pads or wobble boards to increase instability and challenge postural control. Each session remains 30 minutes in length and is supervised for safety and consistency.

Other: Balance Training Group

Interventions

Vagus Nerve Stimulation + Balance Training GroupOTHER

Participants in the experimental group will receive transcutaneous auricular vagus nerve stimulation (taVNS) administered according to standardized clinical protocols. No intervention is provided at baseline, aside from initial assessments. During Weeks 1 and 2, taVNS will be applied daily or as per a specified schedule. The stimulation parameters include: application at the auricular site (such as the tragus), with a frequency of 25 Hz, pulse width of 250 µs, and intensity adjusted to individual tolerance, not exceeding 6 mA. Each session will last for 30 minutes. The same taVNS protocol continues through Weeks 3 and 4. This group will not perform physical balance exercises during the taVNS phase, focusing solely on neuromodulation through vagus nerve stimulation.

Vagus Nerve Stimulation + Balance Training
Balance Training GroupOTHER

Participants in the control group will also undergo baseline assessments without intervention. During Weeks 1 and 2, they will participate in daily or scheduled 30-minute balance training sessions, consisting of 14 basic exercises such as sit-to-stand, tandem stance, and single-leg stance. These exercises are designed to improve static and dynamic balance, and are tailored to the individual's ability and safety level. In Weeks 3 and 4, the balance training progresses in difficulty. This includes increasing repetitions or duration, adding dual-task challenges (like cognitive tasks while balancing), and incorporating tools like foam pads or wobble boards to increase instability and challenge postural control. Each session remains 30 minutes in length and is supervised for safety and consistency

Balance Training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 to 70years who are diagnosed with ischemic brain injury, intracerebral hemorrhage shown by magnetic resonance imaging, or computed tomography.
  • First occurrence of stroke characterized by a unilateral lesion, with an onset time (acute/ subacute) \< 6 months
  • With balance impairment (BBS Score = 21-44);
  • no or mild spasticity on the lower-limb assessed by Modified Ashworth Scale (MAS ≤ 2);
  • sufficient cognition to follow the instructions provided by the therapists and the computer.

You may not qualify if:

  • Individuals exhibiting unstable vital signs, consciousness disorders, or an inability to cooperate with examination and treatment procedures
  • Those with a heart rate below 60 beats per minute, or with implantable devices such as pacemakers or cochlear implants.
  • Other medical or psychological conditions affecting participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital, Rawalpindi

Islamabad, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Hajra Arshad, MS-NMPT*

    Riphah International Unversity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arshad Nawaz Malik, PhD Rehab

CONTACT

03334503754arshad.nawaz@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

May 20, 2026

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

November 20, 2026

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)