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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04752319
Other study ID # HSC-MS-20-1286 (Experiment 3)
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04570774 - Effect of Cerebral and Cerebellar rTMS in Stroke Patient N/A
Not yet recruiting NCT04750551 - BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment (Pilot). N/A
Not yet recruiting NCT04750564 - BreEStim for Motor Recovery in Chronic Stroke With Severe Impairment (Pilot) N/A
Not yet recruiting NCT06029062 - tACS for Sensory Motor Recovery After Stroke N/A
Not yet recruiting NCT06121947 - Safety and Efficacy Study of Implantable Neuromodulation for Poststroke Hemiplegia N/A
Recruiting NCT04830631 - tDCS Response Prediction Using EEG in Stroke
Recruiting NCT04074018 - Impacts of Two Rehabilitation Programs on Chronic Peripheral Facial Paresis N/A