Neuromodulation and Dynamic Balance in Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05135533
• Other study ID #: Pro00113565
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: Shraddha Srivastava, PhD
• Phone: 843-792-6165
• Email: srivasts[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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 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.
• Sham
The Sham group will not receive electrical stimulation.

Other:
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Brooks Rehabilitation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gait speed	Self-selected comfortable walking overground walking speed.	Pre-treatment, midpoint at four weeks, and post-treatment at 12 weeks
Primary	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.	Pre-treatment, midpoint at four weeks, and post-treatment at at 12 weeks