Neuromodulation and Dynamic Balance in Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: Sham; Device: Portable Neuromodulation Stimulation; Other: Gait and balance training

• Registration Number: NCT05135533
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-26
• Study Start: 2023-08-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• At least six months since the onset of Ischemic or hemorrhagic stroke.
• Demonstrate residual paresis in the lower extremity (Fugl-Mayer lower extremity score < 34).
• Are able to provide informed consent demonstrated by their ability to weigh the consequences of participating versus not participating in the study.
• Can walk at least 10 feet with and without assistive device.
• Functional Gait Assessment score <22.

Exclusion Criteria

• Pre-existing neurological disorders.
• Previous stroke affecting the other hemisphere .
• Severe arthritis or orthopedic problems that limit passive range of motion.
• Areas of recent bleeding or open wounds.
• Lack normal sensation on the tongue.
• Received treatment for cancer within the past year.
• Non-removable metal orthodontic devices.
• Oral health problems.
• Are sensitive to nickel, gold or copper.
• Chronic infectious diseases.
• Are pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Sham	-
Portable Neuromodulation Stimulator	Gait and balance training	-
Portable Neuromodulation Stimulator	Portable Neuromodulation Stimulation	-
Sham	Gait and balance training	-

Primary Outcome Measures

Name	Time	Method
Change in gait speed	Pre-treatment, midpoint at four weeks, and post-treatment at 12 weeks	Self-selected comfortable walking overground walking speed.
Change in balance	Pre-treatment, midpoint at four weeks, and post-treatment at at 12 weeks	Functional Gait Assessment (FGA) assesses stability during walking. The score ranges between 0 and 30 with lower scores indicative of poor dynamic balance.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States