BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment (Pilot).

BreEStim for Post-Stroke Motor Recovery

The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with moderate impairment.

Study Overview

• Status: Not yet recruiting
• Conditions: Motor Recovery
• Intervention / Treatment: Device: BreEStim; Device: EStim

• Study Type: Interventional
• Enrollment (Estimated): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheng Li, MD, PhD; Phone Number: (713) 797-7125; Email: sheng.li@uth.tmc.edu
• Study Contact Backup: Name: Shengai Li, MS; Phone Number: 713-797-7561; Email: shengai.li@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center
      • Contact: Shengai Li, MS; Phone Number: 713-797-7561; Email: shengai.li@uth.tmc.edu
      • Contact: Sheng Li, MD, PhD; Phone Number: 713-500-5874; Email: sheng.li@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• has post stroke ≥ 6 months , medically stable;
• Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);
• MAS score ≥ 1, i.e., detectable finger flexor hypertonia;

Exclusion criteria include:

• Patients with visual deficit/neglect; hearing or cognitive impairment;
• Patients with history of pulmonary disease (Asthma, chronic obstruction pulmonary disease, COPD);
• Patients that are currently adjusting tone alternating medications (e.g., baclofen), or
• Patients received botulinum toxin injection to the arm/fingers <4 months, or phenol injections < 2 years;
• Patients with a pacemaker;
• Women who are pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BreEStim; BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.	Device: BreEStim; BreEStim will applied for 10 to 20 minutes.
Experimental: EStim; EStim is transcutaneous electrical nerve stimulation.	Device: EStim; EStim will applied for 10 to 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)	MAS will be performed to check changes of finger flexor spasticity after one session of treatment. The Modified Ashworth scale (MAS) scoring is categorical and ranges from 0 to 4, as follows: 0: No increase in muscle tone; Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion (ROM); More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; Considerable increase in muscle tone, passive movement difficult; Affected part(s) rigid in flexion or extension	Baseline, 5 minutes after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale	FMA will be assessed to test function changes of finger extensors and hand function after one session of treatment. The upper limb motor function domain of the FMA scale will be used, and the score range for this domain is 0 to 66, with a higher score indicating better function.	Baseline, 5 minutes after intervention

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Sheng Li, MD, PhD, University of Texas

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Motor Recovery; BreEStim; Finger flexor spasticity
• Other Study ID Numbers: HSC-MS-20-1286 (Experiment 1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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