Stroke Clinical Trial
Official title:
Strengthening Task Specific Activation of Paretic Hand Muscles After moderate-to- Severe Chronic Stroke
Verified date | May 2024 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Researchers at the University of Pittsburgh are conducting a research study to see how combining brain, nerve, and hand stimulation affect hand movement after stroke. The primary purpose of this study is to examine changes in the connection between the brain and the weak hand muscles after the combined brain, nerve, and hand stimulation. The primary hypothesis is that the combined brain, nerve, and hand stimulation will increase the the connection between the brain and the weak hand muscles. The secondary purpose of this study is to examine changes in weak hand's movement and function after the combined brain, nerve, and hand stimulation. The secondary hypothesis is that the combined brain, nerve, and hand stimulation will increase weak hand movement and function.
Status | Suspended |
Enrollment | 40 |
Est. completion date | January 30, 2026 |
Est. primary completion date | January 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Age between 18-85 years 2. Diagnosis of first-ever subcortical stroke (single cerebrovascular accident) 3. Stroke onset of at least six months prior to the time of participation 4. A score of at least 1 out of 2 on the spherical grasping item of the Fugl-Meyer Upper Extremity Subscale to allow participants to grasp the ball 5. Cognitive skills to actively participate, as indicated by scores of > 23 on the Mini-Mental Status Examination 6. English speaking Exclusion Criteria: 1. Inability to elicit a motor evoked potential (MEP) in the EDC muscle even with a 20% background muscle contraction 2. Presence of severe aphasia 3. Excessive spasticity of the wrist and finger muscles, defined as a Modified Ashworth Score >2 4. Diagnosis of neurological disorders other than stroke 5. History of seizure or epilepsy 6. Orthopedic/musculoskeletal conditions (e.g., arthritis) affecting the upper extremity 7. Presence of metallic implants in the head or neck 8. Currently or planning to become pregnant 9. Difficulty maintaining alertness or remaining still 10. Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators for magnetic resonance imaging (MRI) 11. Bodyweight > 300 lbs due to MRI scanner dimensions (for subjects also undergoing MRI) 12. Psychiatric diagnosis according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-V), or who are on psychotropic medication 13. Life expectancy less than the duration of the study 14. Excessive pain in the paretic hand, defined as a Visual Analog Scale Score >4 15. Participation in concurrent occupational therapy 16. Current use of recreational drugs and stimulants like cocaine and methylenedioxymethamphetamine (MDMA) |
Country | Name | City | State |
---|---|---|---|
United States | Neuromotor Recovery and Rehabilitation Lab | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Amit Sethi | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transcranial magnetic stimulation to evaluate corticospinal transmission | Corticospinal transmission will be assessed by examining the percent change of the peak-to-peak motor evoked potential (MEP) amplitude relative to baseline. | Change from baseline up to 30-minutes post intervention | |
Secondary | Voluntary force production to evaluate motor performance | We will measure force production of the wrist and finger extensors (EDC) to evaluate motor performance using load cells embedded in cushioned customized platforms. Participants will perform isometric wrist and finger extension movements against load cells. We will calculate the percent change of maximum force output. | Change from baseline up to 30-minutes post intervention | |
Secondary | Maximum finger excursions to evaluate motor performance | Three-dimensional biomechanical data will be collected to evaluate motor performance using a motion capture system. Reflective markers will be placed on the participant's paretic forearm, hand, and fingers to track wrist and finger movements during a maximum hand opening task. Hand biomechanics will be evaluated by computing the percent change of maximum finger excursions during the hand opening task. | Change from baseline up to 30-minutes post intervention | |
Secondary | Maximum finger spread to evaluate motor performance | Three-dimensional biomechanical data will be collected to evaluate motor performance using a motion capture system. Reflective markers will be placed on the participant's paretic forearm, hand, and fingers to track wrist and finger movements during a maximum hand opening task. Hand biomechanics will be evaluated by computing the percent change of maximum finger spread during the hand opening task. | Change from baseline up to 30-minutes post intervention | |
Secondary | Box and Block Test | The Box and Block Test (BBT) measures unilateral gross manual dexterity and the ability to release objects. We will calculate the percent change of the total number of blocks transferred in one minute. | Change from baseline up to 30-minutes post intervention |
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