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NCT05736653
PCMS Task After Moderate-to-severe Stroke
Conditions: Stroke
Sex: All
Ages: 18 Years – 80 Years
Phase: NA
Enrollment: 40
Sponsor: Amit Sethi
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Age between 18-80 yearsDiagnosis of first-ever subcortical stroke (single cerebrovascular accident)Stroke onset of at least six months prior to the time of participationLimited functional wrist and finger extension, as indicated by 5-20º active wrist extension and 5-20º active extension in at least two fingersA 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 ballCognitive skills to actively participate, as indicated by scores of > 23 on the Mini-Mental Status ExaminationEnglish speakingExclusion Criteria:Inability to elicit a motor evoked potential (MEP) in the EDC muscle even with a 20% background muscle contractionPresence of severe aphasiaExcessive spasticity of the wrist and finger muscles, defined as a Modified Ashworth Score >2Diagnosis of neurological disorders other than strokeHistory of seizure or epilepsyOrthopedic/musculoskeletal conditions (e.g., arthritis) affecting the upper extremityPresence of metallic implants in the head or neckCurrently or planning to become pregnantDifficulty maintaining alertness or remaining stillFerromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for MRI)Bodyweight > 300 lbs due to MRI scanner dimensions (for subjects also undergoing MRI)Psychiatric diagnosis according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-V), or who are on psychotropic medicationLife expectancy less than the duration of the studyExcessive pain in the paretic hand, defined as a Visual Analog Scale Score >4Participation in concurrent occupational therapyCurrent use of recreational drugs and stimulants like cocaine and MDMA
Source: ClinicalTrials.gov (NCT05736653). StuddyBuddy aggregates publicly available trial information.