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

This study is a randomized clinical trail (RCT) of stroke survivors with chronic (6 to 24 months) hemiplegia randomized to: 1) conventional transcranial direct current stimulation (tDCS), 2) unconventional tDCS, or 3) sham tDCS during contralaterally controlled functional electrical stimulation mediated occupational therapy. The treatment will last 12 weeks and be followed by a 6-month follow-up period. Assessors, therapists and participants will be blinded to which tDCS treatment is received. This will be the first RCT of tDCS + CCFES.

Inclusion criteria

• Age ≥ 21 and ≤ 90
• ≥ 6 and ≤ 24 months since first clinical hemorrhagic or nonhemorrhagic stroke
• Able to follow 3-stage command
• Able to remember 2 of 3 items after 30 minutes
• Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
• Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
• Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
• Medically stable
• ≥ 10° finger and wrist extension
• Skin intact on hemiparetic arm, hand and scalp
• Muscle contraction can be elicited with Transcranial Magnetic Stimulation
• Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale
• Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
• While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.

Exclusion criteria

• Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
• Uncontrolled seizure disorder
• Use of seizure lowering threshold medications and the discretion of the study physician
• Cardiac pacemaker or other implanted electronic device
• Pregnant
• IM Botox injections in any UE muscle in the last 3 months
• Insensate arm, forearm, or hand
• Deficits in communication that interfere with reasonable study participation
• Severely impaired cognition and communication
• Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
• Severe shoulder or hand pain (unable to position hand in the workspace without pain)