RecruitingNot ApplicableNCT03857529

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

Contralaterally Controlled FES Plus Transcranial Direct Current Stimulation for Hand Motor Control After Stroke: A Pilot Study

Sponsor

MetroHealth Medical Center

Enrollment

15 participants

Start Date

Aug 1, 2019

Study Type

INTERVENTIONAL

Conditions

Stroke Rehabilitation Hand

Summary

This pilot study for stroke patients with chronic upper limb hemiplegia will examine the effects of non-invasive brain stimulation and neuromuscular electrical stimulation on hand motor control and corticospinal excitability. Specifically, this study will investigate the effects of timing and delivery of tDCS in conjunction with contralaterally controlled functional electrical stimulation.

Eligibility

Min Age: 21 Years

Inclusion Criteria13

Age ≥ 21
≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke
Able to follow 3-stage commands and 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 extension
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
Skin intact on hemiparetic arm, hand and scalp
While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
No significant visual or hearing impairment

Exclusion Criteria11

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).
Uncontrolled seizure disorder
Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson)
Cardiac pacemaker or other implanted electronic device and/or stent
Pregnant
Intramuscular botox injections in any upper extremity muscle in the last 3 months
Insensate arm, forearm, or hand
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)
Metal implant in the head

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Interventions

DEVICEtranscranial direct current stimulation and electrical stimulator

Contralaterally Controlled Functional Electrical Stimulation: 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 will be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES). Transcranial direct current stimulation (tDCS): TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (1mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration.