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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia

Conditions
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Stroke, Upper Extremity Paresis, Hemiplegia

Intervention / Treatment
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* Device: Active conventional tDCS montage plus CCFES
* Device: Active unconventional tDCS montage plus CCFES
* Device: Sham tDCS plus CCFES
* Behavioral: CCFES with Occupational Therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active conventional tDCS plus CCFES<br>The conventional tDCS montages involves placing the surface anode electrode on the scalp of the lesioned hemisphere and the surface cathode electrode on the scalp of the non-lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice. | Device: Active conventional tDCS montage plus CCFES<br>* 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.<br>Behavioral: CCFES with Occupational Therapy<br>* 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.<br>|
| Active Comparator: Active unconventional tDCS plus CCFES<br>The unconventional tDCS montages involves placing the surface anode electrode on the scalp of the non-lesioned hemisphere and the surface cathode electrode on the scalp of the lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice. | Device: Active unconventional tDCS montage plus CCFES<br>* 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.<br>Behavioral: CCFES with Occupational Therapy<br>* 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.<br>|
| Sham Comparator: Sham tDCS plus CCFES<br>The sham tDCS montages involves placing the surface electrodes on the scalp over the lesioned and the non-lesioned hemisphere. TDCS will not be delivered during CCFES-mediated functional task practice. | Device: Sham tDCS plus CCFES<br>* 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.<br>Behavioral: CCFES with Occupational Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and Blocks Test (BBT) | The BBT counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds. | Change in BBT will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Extremity Fugl-Meyer Assessment (UEFM). | The UEFM is a reliable and valid measure of post-stroke upper limb motor impairment | Change in UEFM will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Rehabilitation, Therapy, Electrical Stimulation, Brain stimulation, Hand, CCFES, Motor Cortex, TMS, Motor Recovery, Central Nervous System, CVA, Upper Limb