Motor Function, Stroke, Stroke, Acute
Conditions
Brief summary
We propose to enhance the effects of brain plasticity using a powerful noninvasive technique for brain modulation consisting of navigated transcranial magnetic stimulation (TMS) priming with transcranial direct current stimulation (tDCS) in combination with motor-training-like constraint-induced movement therapy (CIMT).
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation (rTMS)
Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous) prime with anodal Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint induced movement therapy. Each session will last 20 minutes.
DEVICETranscranial Direct Current Stimulation (tDCS
Subjects will either undergo sham Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint-induced movement therapy.
Sponsors
King Fahad Specialist Hospital Dammam
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Double (Participant, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. age 18-90 2. first-time clinical ischemic or hemorrhagic cerebrovascular accident as noted in the radiological (or physician's) report; 3. the ability to extend =20° at the wrist and 10° at the metacarpophalangeal and interphalangeal joints of all digits; 4. participants must demonstrate adequate balance while wearing the restraint; 5. the ability to stand from a sitting position and the ability to stand for at least 2 minutes with or without upper extremity support; 6. weakness, defined as score of 15-55 (out of 66) on arm motor Fugl-Meyer (FM) scale; and 7. stroke onset more then 6 months prior to study enrollment.
Exclusion criteria
1. significant pre-stroke disability; 2. where applicable (a history of depression before the stroke); 3. any substantial decrease in alertness, language reception, or attention that might interfere with understanding the instructions for the motor testing; 4. excessive pain in any joint of the paretic extremity; 5. contraindications to single-pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants; 6. advanced liver, kidney, cardiac, or pulmonary disease; 7. a terminal medical diagnosis consistent with survival 1 year; 8. coexistent major neurological or psychiatric disease (to decrease the number of confounders); 9. a history of significant drug abuse in the prior 6 months; 10. the use of certain neuropsychotropic drugs such as tricyclics, antidepressants, or 51 of 66 carbamazepine; 11. active enrollment in a separate intervention study targeting stroke recovery; ( 12. previously applied constraint-induced motor therapy and/or tDCS treatment for stroke; and 13. a history of epilepsy before stroke (or episodes of seizures within the last six months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the neurophysiologic findings of cortical plasticity. | Before 10 sessions, before and after each session (every day), after 10 daily sessions and after 6 weeks | Expressed as percent motor resting threshold and numerical values of motor evoked potential. The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould). The percentage of inhibition or facilitation for each before and after stimulation will be calculated. |
| To assess the motor function changes . | before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days | Change from motor hand function: ordinal variable measured through the Jebsen-Taylor Hand Function Test (JTHFT). The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large, lightweight, and heavy objects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensory-motor function of the upper limb | before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days | This consists of a quantitative scale developed to measure (motor recovery, balance, sensation, and some joint function) recovery of the motor function of stroke patients. Measured through the Fugl-Meyer Rating Scale, which expressed in values from 0 to 66. |
| Degree of disability: | before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days | This consists of a quantitative scale developed to measured the disability caused by impairments in stroke patients. The Barthel Index Score (Activities of Daily Living) measured through ranges from 0 to 20, principally concerned with physical aspects of disability. |
Outcome results
None listed