BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment After a Long-term Use (Pilot).

The University of Texas System (UT)

Status: Begins enrollment in 3 months

Conditions: Motor Recovery

Treatments: Device: EStim; Device: BreEStim

Study type: Interventional

Funder types: Other

Identifiers

NCT04752319

HSC-MS-20-1286 (Experiment 3)

Details and patient eligibility

About

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 after a long-term use.

Enrollment: 4 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

BreEStim

Experimental group

Description:

BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.

Treatment:

Device: BreEStim

EStim

Experimental group

Description:

EStim is transcutaneous electrical nerve stimulation.

Treatment:

Device: EStim