tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia
tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia
MetroHealth Medical Center
63 participants
Jul 1, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria14
- 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 Criteria11
- 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)
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Interventions
tDCS is a non-invasive brain stimulation technique. A small machine (9-volt battery operated device) will use a weak amount of electric current to stimulate the brain without any invasive procedure. Electrodes, covered in sponges soaked in saline, will be placed over certain parts of your head and held in place using a rubber strap. In addition, an electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract.
tDCS is a non-invasive brain stimulation technique. A small machine (9-volt battery operated device) will use a weak amount of electric current to stimulate the brain without any invasive procedure. Electrodes, covered in sponges soaked in saline, will be placed over certain parts of your head and held in place using a rubber strap. In addition, An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract.
An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator.
An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator. During the lab visits, all participants will use CCFES to assist hand opening during occupational therapy task practice.
Locations(1)
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NCT05866003