Hemiplegia, Stroke, Upper Extremity Paresis
Conditions
Keywords
Stroke, Rehabilitation, Therapy, Electrical Stimulation, Brain stimulation, Hand, CCFES, Motor Cortex, TMS, Motor Recovery, Central Nervous System, CVA, Upper Limb
Brief 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.
Detailed description
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.
Interventions
DEVICEActive conventional tDCS montage plus CCFES
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.
DEVICEActive unconventional tDCS montage plus CCFES
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.
DEVICESham tDCS plus CCFES
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.
BEHAVIORALCCFES with Occupational Therapy
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.
Sponsors
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 21 and ≤ 90 2. ≥ 6 and ≤ 24 months since first clinical hemorrhagic or nonhemorrhagic stroke 3. Able to follow 3-stage command 4. Able to remember 2 of 3 items after 30 minutes 5. Full volitional elbow extension/flexion and hand opening/closing of unaffected limb 6. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice 7. Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment 8. Medically stable 9. ≥ 10° finger and wrist extension 10. Skin intact on hemiparetic arm, hand and scalp 11. Muscle contraction can be elicited with Transcranial Magnetic Stimulation 12. Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale 13. Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment 14. While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
Exclusion criteria
1. Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS). 2. Uncontrolled seizure disorder 3. Use of seizure lowering threshold medications and the discretion of the study physician 4. Cardiac pacemaker or other implanted electronic device 5. Pregnant 6. IM Botox injections in any UE muscle in the last 3 months 7. Insensate arm, forearm, or hand 8. Deficits in communication that interfere with reasonable study participation 9. Severely impaired cognition and communication 10. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation) 11. Severe shoulder or hand pain (unable to position hand in the workspace without pain)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Box and Blocks Test (BBT) | Change in BBT will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks | The BBT counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper Extremity Fugl-Meyer Assessment (UEFM). | Change in UEFM will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks | The UEFM is a reliable and valid measure of post-stroke upper limb motor impairment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neurophysiologic Assessments | Change in neurophysiologic assessments will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks | Neurophysiologic assessments will be performed using TMS. Measures of excitability and inhibition will be measured. |
Countries
United States
Contacts
Primary ContactAmy Friedl, MS,OTR/L
Backup ContactDavid Cunningham, PhD
Outcome results
None listed