Neuromodulation and Dynamic Balance in Stroke

NCT ID: NCT05135533

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-28
• Study Completion Date: 2025-07-24

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Portable Neuromodulation Stimulator

Group Type: EXPERIMENTAL

Portable Neuromodulation Stimulation

Intervention Type: DEVICE

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.

Gait and balance training

Intervention Type: OTHER

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.

Sham

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

The Sham group will not receive electrical stimulation.

Gait and balance training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

Sham

The Sham group will not receive electrical stimulation.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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.
• Have dementia

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brooks Rehabilitation

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Steven Kautz

Depertment Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Kautz, PhD

Role: STUDY_CHAIR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro00113565

Identifier Type: -

Identifier Source: org_study_id