Stroke Clinical Trial
Official title:
A Novel Brain Stimulation for Bimanual Motor Function and Control in Chronic Stroke
The long-term goal of this project is to develop and test upper Iimb rehabilitation interventions that can improve bimanual motor function, or the ability to use both arms and hands together, for stroke survivors with moderate to severe impairment. This study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 12 visits over a period of 6 weeks. The study will include the following site visits: - Eligibility Screening and Informed Consent Visit - Baseline testing (4 visits total): 1 visit each for MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs - Repeat baseline testing (4 visits total) of MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs - 12 intervention visits during which patients will receive upper limb therapy in conjunction with non-invasive brain stimulation - Repeat testing (4 visits total) of MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs - A follow-up visit 1 month after the completion of interventions
Status | Recruiting |
Enrollment | 18 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Age 18-90 yrs - =6 months since first clinical stroke - Impairment of the paretic hand, indicated by a score of <= 11 out of 14 on the hand section of UEFM - Sufficient range of motion in the wrist and fingers for functional task practice: have at least 10 degrees active wrist extension, 10 degrees active thumb abduction/extension, and 10 degrees active extension in at least 2 additional digits - Sufficient active shoulder and elbow movement to volitionally position the paretic hand in the workspace for table-top task practice Exclusion Criteria: - Brainstem or cerebellar stroke - Bilateral strokes or multiple strokes affecting sensorimotor structures - Cognitive impairment (Mini-Mental State Examination <24) - Severe impairment of the paretic hand that limits functional task practice (UEFM hand score < 4 out of 14) - Severe spasticity (Modified Ashworth Scale >3) or upper limb contracture - Occupational therapy or upper limb Botox completed = 2 months prior - Contraindications to TMS or MRI (e.g. metal implant in head, seizure history, cardiac pacemaker) |
Country | Name | City | State |
---|---|---|---|
United States | Lerner Research Institute, Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic | American Heart Association |
United States,
Haaland KY, Mutha PK, Rinehart JK, Daniels M, Cushnyr B, Adair JC. Relationship between arm usage and instrumental activities of daily living after unilateral stroke. Arch Phys Med Rehabil. 2012 Nov;93(11):1957-62. doi: 10.1016/j.apmr.2012.05.011. Epub 2012 May 24. — View Citation
Liao WW, Whitall J, Wittenberg GF, Barton JE, McCombe Waller S. Not all brain regions are created equal for improving bimanual coordination in individuals with chronic stroke. Clin Neurophysiol. 2019 Aug;130(8):1218-1230. doi: 10.1016/j.clinph.2019.04.711. Epub 2019 May 13. — View Citation
Sankarasubramanian V, Machado AG, Conforto AB, Potter-Baker KA, Cunningham DA, Varnerin NM, Wang X, Sakaie K, Plow EB. Inhibition versus facilitation of contralesional motor cortices in stroke: Deriving a model to tailor brain stimulation. Clin Neurophysiol. 2017 Jun;128(6):892-902. doi: 10.1016/j.clinph.2017.03.030. Epub 2017 Mar 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Bimanual Assessment Measure (BAM) | Measure of the functional ability to perform 11 bimanual tasks scoring the spontaneous role of the affected hand, timing, and quality of movement. | Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up. | |
Secondary | Change in Bimanual Grip Force Modulation Task | Measure the ability to produce and maintain differing levels of force using hand dynamometers. This measurement represents patient's ability to perform independent tasks with each hand. | Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up. | |
Secondary | Change in ABILHAND | ABILHAND assesses the participant's perception of bimanual ability by rating the difficulty of performing 23 bimanual activities without assistance on a 3 point ordinal scale (impossible, difficult, easy) This test has excellent reliability (ICC = 0.85-0.91). | Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up. | |
Secondary | Change in Upper Extremity Fugyl-Meyer Score (UEFM) | Impairment will be measured using UEFM, one of the most widely used assessments in stroke. UEFM will serve as our primary outcome because it is sensitive to discerning the effects of rTMS/rehabilitation, and has excellent reliability (ICC= 0.97), consistency (Cronbach's a= 0.84) and validity. UEFM has a score ranging from 0-66 (0 meaning there is no movement of the paretic arm, and 66 meaning there is no functional limitation of the paretic arm.) | Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up. | |
Secondary | Change in Wolf Motor Function Test (WMFT) | Functional ability to use the paretic upper limb in a variety of tasks will be assessed using WMFT. Time to complete each task will be noted and converted to rate (60/Performance Time (sec)), optimized for measurement in moderately/severely-impaired patients. Grip strength will also be recorded with WMFT. | Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up. | |
Secondary | Change Resting State Functional Magnetic Resonance Imaging(rsfMRI) | Functional connectivity will assess the connectivity between cHMC and iM1 using temporal correlation of blood oxygneation level-dependent (BOLD) signal given as z-scores. | Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) | |
Secondary | Change in excitability of cortical and corticospinal physiology (TMS) | Transcranial magnetic stimulation will be used to test crossed and uncrossed output from both hemispheres and will be measured as motor evoked potentials(MEPS) of the Extensor Digitorum Communis (EDC). | Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) |
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