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COMPLETED
NCT05135533
NA

Neuromodulation and Dynamic Balance in Stroke

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

Summary

Portable Neuromodulation Stimulator (PoNS) is non-invasive stimulation device placed on the tongue to stimulate those brain regions understood to be important for maintaining balance. This research study aims to collect evidence that PoNS therapy along with balance training improves postural and walking stability post-stroke.

Official title: Cranial-nerve Non-invasive Neuromodulation and Dynamic Balance in Chronic Stroke Survivors

Key Details

Gender

All

Age Range

22 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2023-08-28

Completion Date

2025-07-24

Last Updated

2026-08-13

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Portable Neuromodulation Stimulation

The PoNS group will receive electrical stimulation. Net direct current to the tongue electrode less than 1 µA (micro ampere) will be administered three times a week for four weeks in-lab setting, followed by three times a week for eight weeks at-home setting. Participants will continue to be enrolled in the study for additional 12 weeks without any intervention to evaluate long term effects.

DEVICE

Sham

The Sham group will not receive electrical stimulation.

OTHER

Gait and balance training

During each session participants will receive gait training exercises for 20 minutes, 20 minutes of balance training exercises, and 20 minutes of breathing exercise three times a week for four weeks in-lab setting. This will be followed by 20 minutes of gait training exercises, 20 minutes of balance training exercises, and 20 minutes of breathing exercise three times a week for eight weeks at-home setting. Participants will continue to be enrolled in the study for additional 12 weeks without any intervention to evaluate long term effects.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States