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

Motor Recovery Clinical Trial

Official title:

BreEStim for Post-Stroke Motor Recovery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04752319
• Other study ID #: HSC-MS-20-1286 (Experiment 3)
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Sheng Li, MD, PhD
• Phone: (713) 797-7125
• Email: sheng.li[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 moderate impairment after a long-term use.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4
• Est. completion date: March 31, 2028
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Motor Recovery

Intervention

Device:
• BreEStim
BreEStim will be applied for 10 to 20 minutes per session for multiple sessions
• EStim
EStim will be applied for 10 to 20 minutes per session for multiple sessions

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, after 10 intervention sessions, about 3 weeks
Secondary	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, after 10 intervention sessions, about 3 weeks