rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke

Launched by THE CLEVELAND CLINIC · Mar 8, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment aimed at helping individuals who have experienced a severe stroke and have difficulty using their arms. Researchers are studying a combination of two therapies: repetitive transcranial magnetic stimulation (rTMS), which uses a painless magnetic field to stimulate certain areas of the brain, and contralaterally controlled functional electrical stimulation (CCFES), which uses gentle electrical currents to help improve hand movement. The goal is to see if this combined approach can lead to better recovery of arm and hand function for patients who have been living with these challenges for more than six months.

To participate in this trial, individuals must be between 18 and 90 years old, have had their first stroke more than six months ago, and have severe difficulty moving their affected arm. Participants should be able to follow simple instructions and have some movement in their shoulders and elbows. If selected, they will undergo the new therapies and be monitored for their progress. It’s important to note that individuals with certain medical conditions, such as metal implants in the head or a history of seizures, may not be eligible. This study represents a promising step toward improving recovery options for stroke survivors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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