Status:
COMPLETED
Synchronized Brain and Hand Stimulation After Stroke
Lead Sponsor:
Amit Sethi
Conditions:
Stroke
Upper Extremity Paresis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Among the 795,000 individuals who sustain a stroke annually in the United States, 65% continue to experience moderate-to-severe impairments in one hand six months or more, which limits their ability t...
Eligibility Criteria
Inclusion
- Male or female (either right or left handed) with unilateral hemiparesis after stroke;
- Stroke onset of at least six months prior to the time of participation;
- Ability to elicit motor evoked potential in the Extensor digitorum communis (EDC) muscle
- Ability to grasp, as indicated by a score of at least 1 (out of 2) on the finger mass flexion and cylindrical grasp items of Upper Extremity Fugl-Meyer scale
- age between 18-80 years
Exclusion
- Presence of severe aphasia , measured by cognitive and/or language impairments that preclude the ability to follow simple instructions;
- Excessive spasticity of wrist and finger muscles, defined as a Modified Ashworth Score more than or equal to 3, which may limit the ability to open the hand/fingers;
- Diagnosis of neurological disorders other than stroke, which may confound the results;
- Has touch and proprioceptive sensory deficits determined via a score of 0 on the position sense section (section H) of the Fugl Meyer Upper Extremity assessment proprioception, which may limit the ability to report excessive amount of tingling due to hand stimulation
- History of seizure or epilepsy as the effects of TMS are not tested in individuals with seizures or epilepsy;
- Orthopaedic/musculoskeletal conditions (eg, arthritis) affecting the upper extremity, which may limit the ability to move the affected hand
- Presence of metallic implants in the head or neck for TMS;
- Currently or planning to become pregnant, as the effects of TMS are not tested not pregnant women;
- Difficulty maintaining alertness or remaining still for MRI;
- Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for MRI);
- Bodyweight \> 300 lbs due to MRI scanner dimensions
- 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, which may confound the results
- Cognitive impairments, defined as a score of \< 23 on the Mini Mental Status Examination, which may limit the ability to follow the commands in the study
- Excessive pain \> equal to 5 on Visual Analog Scale in the more-affected upper extremity, which may limit the ability to participate in the study
- History of schizophrenia, Bipolar disorder (type I or II) \[Answer yes to questions 16 and items of the (hypo) maniac module of the The Mini International Neuropsychiatric Interview\], current moderate, severe depression (Scores of \>10 on Patient Health Questionnaire-9) and other neurological or medical conditions that could confound results.
- Life expectancy less than the duration of the study
- Hemispatial neglect, which may limit the ability to pay attention to the affected hand
- Participating in concurrent therapy, which may confound the results
- We will exclude children because although stroke may occur in children, the protocol is addressing stoke in adults and the devices are not approved for use in children
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04502290
Start Date
October 1 2020
End Date
May 22 2024
Last Update
July 15 2025
Active Locations (1)
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1
Neuromotor Recovery and Rehabilitation Lab
Pittsburgh, Pennsylvania, United States, 15260