Status:
RECRUITING
rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Stroke
Hemiplegia
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This study is a necessary and important step in the development of a new therapy for upper limb functional recovery in patients with severe motor impairment. It is the first clinical trial of non-inva...
Detailed Description
Overall Study Design Summary: We propose a 5-yr RCT in which 72 stroke patients who are \>6 months post-stroke are randomized to 12 wks of one of 3 treatments: (1) CCFES + cHMC facilitation, (2) CCFES...
Eligibility Criteria
Inclusion
- age 18 to 90 years old at time of randomization
- greater than 6 months since a first clinical cortical or subcortical, ischemic or hemorrhagic stroke
- severe upper limb hemiparesis defined as less than 10° active wrist extension or less than 10° active thumb abduction/extension or less than 10° active extension in at least two additional digits (i.e., will not meet minimum CIMT criteria)
- ability to follow 3-stage commands and can remember 2 items from a list of 3 items after 3 minutes
- adequate active movement of shoulder and elbow to position the paretic hand on one's lap for performance of functional task practice and CCFES-assisted hand opening exercises
- skin intact on hemiparetic arm
- surface electrical stimulation of the paretic finger and thumb extensors produces functional hand opening without pain
- able to hear and respond to cues from stimulator
- completed occupational therapy at least 2 months prior to enrollment (no concomitant OT)
- full volitional hand opening/closing of the non-paretic hand
- ability to follow instructions for putting on and operating the CCFES stimulator or a caregiver available to provide assistance
Exclusion
- metal implant in the head
- history of seizures as an adult
- history of alcohol or substance abuse less than 10yrs prior to enrollment
- intake of anticonvulsants or anti-depressants contraindicated with TMS
- cardiac pacemaker or other programmable implant
Key Trial Info
Start Date :
May 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03870672
Start Date
May 14 2019
End Date
April 30 2026
Last Update
September 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lerner Research Institute; Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195