Neuromodulation and Dynamic Balance in Stroke

Sponsor

Medical University of South Carolina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05135533

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Portable Neuromodulation Stimulation Device: Sham Other: Gait and balance training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Portable Neuromodulation Stimulator	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. Other: Gait and balance training During each session participants will walk on a treadmill at their fastest comfortable walking speed for 10 minutes followed by 30 minutes of balance training exercises three times a week for four weeks.
Sham Comparator: Sham	Device: Sham The Sham group will not receive electrical stimulation. Other: Gait and balance training During each session participants will walk on a treadmill at their fastest comfortable walking speed for 10 minutes followed by 30 minutes of balance training exercises three times a week for four weeks.

Arm

Intervention/Treatment

Experimental: Portable Neuromodulation Stimulator

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.

Other: Gait and balance training

During each session participants will walk on a treadmill at their fastest comfortable walking speed for 10 minutes followed by 30 minutes of balance training exercises three times a week for four weeks.

Sham Comparator: Sham

Device: Sham

The Sham group will not receive electrical stimulation.

Other: Gait and balance training

Outcome Measures

Primary Outcome Measures

Change in gait speed [Pre-treatment and post-treatment following four weeks of intervention]
Self-selected comfortable walking overground walking speed.
Change in balance [Pre-treatment and post-treatment following four weeks of intervention]
Functional Gait Assessment (FGA) assesses stability during walking. The score ranges between 0 and 30 with lower scores indicative of poor dynamic balance.

Secondary Outcome Measures

Change in Postural balance [Pre-treatment and post-treatment following four weeks of intervention]
Sensory organization test (SOT) score that is the gold standard for quantifying postural balance and fall risk. The score ranges between 0 and 100 with lower scores indicative of poor balance.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.
Have Berg Balance Scale <47.

Exclusion Criteria:

Pacemaker or other implanted device or metal objects in the head.
Pre-existing neurological disorders.
Dementia.
Multiple strokes.
Severe arthritis or orthopedic problems that limit passive range of motion.
Non-MR (Magnetic Resonance) compatible implants or severe claustrophobia.
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.
History of seizures.
Chronic infectious diseases.
Uncontrolled hypertension or diabetes.
Are pregnant.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Study Chair: Steven Kautz, PhD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Steven Kautz, Depertment Chair, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT05135533

Other Study ID Numbers:

Pro00113565

First Posted:

Nov 26, 2021

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Aug 5, 2022