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Recruiting NCT04750564

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

No phase Interventional Motor Recovery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BreEStim, EStim.
Who it may be relevant to
Registry conditions: Motor Recovery. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

BreEStim for Post-Stroke Motor Recovery

Overview

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.

Interventions

  • Device BreEStim
    BreEStim will applied for 10 to 20 minutes.
  • Device EStim
    EStim will applied for 10 to 20 minutes.

Primary outcome measures

  • Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS) [Time frame: Baseline, 5 minutes after intervention]
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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center — Houston

Identifiers

NCT: NCT04750564 · HSC-MS-20-1286 (Experiment 2)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗