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

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ClinicalTrials.gov Identifier: NCT04750564
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
Sheng Li, The University of Texas Health Science Center, Houston

Study Description
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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.

Condition or disease Intervention/treatment Phase
Motor Recovery Device: BreEStim Device: EStim Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: BreEStim for Post-Stroke Motor Recovery
Actual Study Start Date : April 2, 2021
Estimated Primary Completion Date : August 10, 2022
Estimated Study Completion Date : August 10, 2022
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS) [ Time Frame: Baseline, 5 minutes after intervention ]

    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


Secondary Outcome Measures :
  1. Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale [ Time Frame: Baseline, 5 minutes after intervention ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04750564


Contacts
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Contact: Sheng Li, MD, PhD (713) 797-7125 sheng.li@uth.tmc.edu
Contact: Shengai Li, MS 713-797-7561 shengai.li@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77030
Contact: Sheng Li, MD, PhD    713-500-5874    sheng.li@uth.tmc.edu   
Contact: Shengai Li, MS    713-797-7561    shengai.li@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Sheng Li, MD, PhD University of Texas
More Information
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Responsible Party: Sheng Li, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04750564    
Other Study ID Numbers: HSC-MS-20-1286 (Experiment 2)
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sheng Li, The University of Texas Health Science Center, Houston:
Finger flexor spasticity
Motor Recovery
BreEStim