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Neuromodulation and Dynamic Balance in Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Portable Neuromodulation Stimulation
Sham
Gait and balance training
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

22 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Portable Neuromodulation Stimulator

Sham

Arm Description

Outcomes

Primary Outcome Measures

Change in gait speed
Self-selected comfortable walking overground walking speed.
Change in balance
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

Full Information

First Posted
November 15, 2021
Last Updated
August 29, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT05135533
Brief Title
Neuromodulation and Dynamic Balance in Stroke
Official Title
Cranial-nerve Non-invasive Neuromodulation and Dynamic Balance in Chronic Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Portable Neuromodulation Stimulator
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Portable Neuromodulation Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
The Sham group will not receive electrical stimulation.
Intervention Type
Other
Intervention Name(s)
Gait and balance training
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in gait speed
Description
Self-selected comfortable walking overground walking speed.
Time Frame
Pre-treatment, midpoint at four weeks, and post-treatment at 12 weeks
Title
Change in balance
Description
Functional Gait Assessment (FGA) assesses stability during walking. The score ranges between 0 and 30 with lower scores indicative of poor dynamic balance.
Time Frame
Pre-treatment, midpoint at four weeks, and post-treatment at at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shraddha Srivastava, PhD
Phone
843-792-6165
Email
srivasts@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Kautz, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Chair
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shraddha Srivastava, PhD
Phone
843-792-6165
Email
srivasts@musc.edu
First Name & Middle Initial & Last Name & Degree
Shraddha Srivastava

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data that underlie the results reported in the article, after de-identification.
IPD Sharing Time Frame
Immediately following publication no end date
IPD Sharing Access Criteria
anyone who wishes to access the data

Learn more about this trial

Neuromodulation and Dynamic Balance in Stroke

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