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

NCT04750564 | Not Yet Recruiting FDA Device

• 1 other identifier: HSC-MS-20-1286 (Experiment 2)
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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 severe impairment.

Conditions

Motor Recovery

Keywords

Finger flexor spasticity; Motor Recovery; BreEStim

Outcome Measures

Primary Outcomes (1)

• 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 1. 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) 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension

  Baseline, 5 minutes after intervention

Secondary Outcomes (1)

• Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale

  Baseline, 5 minutes after intervention

Study Arms (2)

BreEStim

EXPERIMENTAL

BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.

Device: BreEStim

EStim

EXPERIMENTAL

EStim is transcutaneous electrical nerve stimulation.

Device: EStim

Interventions

BreEStim DEVICE

BreEStim will applied for 10 to 20 minutes.

BreEStim

EStim DEVICE

EStim will applied for 10 to 20 minutes.

EStim

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Study Officials

• Sheng Li, MD, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Li, MD, PhD

CONTACT

(713) 797-7125; sheng.li@uth.tmc.edu

Shengai Li, MS

CONTACT

713-797-7561; shengai.li@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 11, 2021
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)