Hand, Rehabilitation, Stroke
Conditions
Brief 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.
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.
Sponsors
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 21 2. ≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke 3. Able to follow 3-stage commands and remember 2 of 3 items after 30 minutes 4. Full volitional elbow extension/flexion and hand opening/closing of unaffected limb 5. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice 6. Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment 7. Medically stable 8. ≥ 10° finger extension 9. 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 10. Skin intact on hemiparetic arm, hand and scalp 11. While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain. 12. No significant visual or hearing impairment
Exclusion criteria
1. 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). 2. Uncontrolled seizure disorder 3. Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson) 4. Cardiac pacemaker or other implanted electronic device and/or stent 5. Pregnant 6. Intramuscular botox injections in any upper extremity muscle in the last 3 months 7. Insensate arm, forearm, or hand 8. Severely impaired cognition and communication 9. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation) 10. Severe shoulder or hand pain (unable to position hand in the workspace without pain) 11. Metal implant in the head
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corticospinal Excitability | up to one hour post intervention | Change in corticospinal excitability will be measured with transcranial magnetic stimulation |
| Reaction Time | up to one hour post intervention | Change in reaction time will be assessed with visual and auditory cues. |
Countries
United States
Contacts
Primary ContactDavid A Cunningham, PhD
Outcome results
None listed