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

Description

After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement. The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke.

Conditions

Stroke, Upper Extremity Paresis, Hemiplegia

Study Overview

Study Details

Study overview

After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement. The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke.

tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia

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

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Cleveland

MetroHealth Medical Center, Cleveland, Ohio, United States, 44109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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)

Ages Eligible for Study

21 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MetroHealth Medical Center,

David A Cunningham, PhD, PRINCIPAL_INVESTIGATOR, MetroHealth Medical Center and Case Western Reserve University

Study Record Dates

2028-04