tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia

Launched by METROHEALTH MEDICAL CENTER · May 9, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how different types of non-invasive brain stimulation can help people recover their ability to move their hands after having a stroke. After a stroke, many people struggle to open and use their affected hand, and this study aims to find out which method combined with therapy is the most effective at improving hand movement. Participants will be trying out three different brain stimulation techniques alongside rehabilitation therapy to see which one helps them recover better.

To be eligible for this trial, you need to be between 21 and 90 years old, have had your first stroke between 6 to 24 months ago, and be able to follow simple commands and remember some information. Participants should also have some movement in their unaffected arm and be able to sit unassisted in a chair during the assessment. If you join the trial, you'll receive specialized therapy and brain stimulation, and you'll be closely monitored to ensure your safety and comfort throughout the process. It's a great opportunity for those looking to improve their hand function after a stroke!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 21 and ≤ 90
• • 2. ≥ 6 and ≤ 24 months since first clinical hemorrhagic or nonhemorrhagic stroke
• • 3. Able to follow 3-stage command
• • 4. Able to remember 2 of 3 items after 30 minutes
• • 5. Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
• • 6. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
• • 7. Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
• • 8. Medically stable
• • 9. ≥ 10° finger and wrist extension
• • 10. Skin intact on hemiparetic arm, hand and scalp
• • 11. Muscle contraction can be elicited with Transcranial Magnetic Stimulation
• • 12. Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale
• • 13. Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
• • 14. While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
• Exclusion Criteria:
• • 1. Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
• • 2. Uncontrolled seizure disorder
• • 3. Use of seizure lowering threshold medications and the discretion of the study physician
• • 4. Cardiac pacemaker or other implanted electronic device
• • 5. Pregnant
• • 6. IM Botox injections in any UE muscle in the last 3 months
• • 7. Insensate arm, forearm, or hand
• • 8. Deficits in communication that interfere with reasonable study participation
• • 9. Severely impaired cognition and communication
• • 10. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
• • 11. Severe shoulder or hand pain (unable to position hand in the workspace without pain)