Improving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation

Launched by METROHEALTH MEDICAL CENTER · Feb 26, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring new ways to help stroke patients regain control of their hands after experiencing weakness on one side of their body, a condition known as hemiplegia. The study will test a combination of two treatments: non-invasive brain stimulation, which gently stimulates the brain, and functional electrical stimulation, which uses small electrical pulses to help muscles move. By carefully timing and delivering these treatments, researchers hope to improve hand movement and brain activity related to motor control.

To participate in this study, individuals need to be at least 21 years old and have had their first stroke at least six months ago. Also, they should be able to follow simple commands and have some movement in their unaffected arm. Participants will need to sit comfortably during the sessions and must not have any other significant neurological conditions. If someone meets these criteria, they can expect to engage in exercises designed to improve their hand function, while also receiving these innovative treatments. This trial is currently recruiting participants, and the goal is to find effective rehabilitation methods for stroke survivors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 21
• • 2. ≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke
• • 3. Able to follow 3-stage commands and remember 2 of 3 items after 30 minutes
• • 4. Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
• • 5. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
• • 6. Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
• • 7. Medically stable
• • 8. ≥ 10° finger extension
• • 9. Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the manual muscle test AND a score of
• • ≥1 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
• • 10. Skin intact on hemiparetic arm, hand and scalp
• • 11. While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
• • 12. No significant visual or hearing impairment
• Exclusion Criteria:
• • 1. Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, multiple sclerosis).
• • 2. Uncontrolled seizure disorder
• • 3. Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson)
• • 4. Cardiac pacemaker or other implanted electronic device and/or stent
• • 5. Pregnant
• • 6. Intramuscular botox injections in any upper extremity muscle in the last 3 months
• • 7. Insensate arm, forearm, or hand
• • 8. Severely impaired cognition and communication
• • 9. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
• • 10. Severe shoulder or hand pain (unable to position hand in the workspace without pain)
• • 11. Metal implant in the head