Neuromodulation and Dynamic Balance in Stroke

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Stroke

Treatments: Device: Portable Neuromodulation Stimulation; Other: Gait and balance training; Device: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT05135533

Pro00113565

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 22 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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53 participants in 2 patient groups

Portable Neuromodulation Stimulator

Experimental group

Treatment:

Other: Gait and balance training

Device: Portable Neuromodulation Stimulation

Sham

Sham Comparator group

Treatment:

Device: Sham

Other: Gait and balance training