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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke, Rehabilitation, Hand

Intervention / Treatment
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* Device: transcranial direct current stimulation and electrical stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conventional tDCS concurrent with CCFES<br>tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere | Device: transcranial direct current stimulation and electrical stimulator<br>* 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.<br>|
| Experimental: unconventional tDCS concurrent with CCFES<br>tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere | Device: transcranial direct current stimulation and electrical stimulator<br>* 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.<br>|
| Experimental: conventional tDCS preceding CCFES<br>tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere | Device: transcranial direct current stimulation and electrical stimulator<br>* 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.<br>|
| Experimental: unconventional tDCS preceding CCFES<br>tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere | Device: transcranial direct current stimulation and electrical stimulator<br>* 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.<br>|
| Sham Comparator: sham tDCS with CCFES<br>sham tDCS preceding and concurrent with CCFES | Device: transcranial direct current stimulation and electrical stimulator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corticospinal Excitability | Change in corticospinal excitability will be measured with transcranial magnetic stimulation | up to one hour post intervention | 
| Reaction Time | Change in reaction time will be assessed with visual and auditory cues. | up to one hour post intervention |