Study Results
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View full resultsBasic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2015-01-15
2020-03-15
Brief Summary
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Detailed Description
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The study is an experimental randomized study comparing the effects of transcranial random noise stimulation with functional electrical stimulation to functional electrical stimulation alone on recovery of function in the more-affected hand in individuals with chronic stroke.
Participants were randomized to receive transcranial random noise stimulation and functional electrical stimulation-facilitated task practice or sham-transcranial random noise stimulation and functional electrical stimulation-facilitated task practice.
Participants received 18 treatment sessions over 6 weeks (3 times/week for 6 weeks).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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tRNS and FES facilitated task practice
In this arm, participants received real transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice
Participants were randomized to one of the two intervention groups \[transcranial current stimulation (tRNS) and functional electrical stimulation (FES) or FES with sham tRNS\] before pre-intervention testing. After randomization, participants underwent pre-intervention testing, followed by intervention 3 times per week for 6 weeks. Each intervention session lasted for 1 hour, where tRNS or sham-tRNS were delivered concurrently with the FES-facilitated task practice. tRNS or sham-tRNS was delivered for the first 30 minutes. Both tRNS and sham tRNS were delivered by the Starstim system. FES was delivered using the Neuromove system. All participants were treated by a licensed occupational therapist, who was trained on a manualized protocol.
sham tRNS and FES facilitated task practice
In this arm, participants received sham transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice
Participants were randomized to one of the two intervention groups \[transcranial current stimulation (tRNS) and functional electrical stimulation (FES) or FES with sham tRNS\] before pre-intervention testing. After randomization, participants underwent pre-intervention testing, followed by intervention 3 times per week for 6 weeks. Each intervention session lasted for 1 hour, where tRNS or sham-tRNS were delivered concurrently with the FES-facilitated task practice. tRNS or sham-tRNS was delivered for the first 30 minutes. Both tRNS and sham tRNS were delivered by the Starstim system. FES was delivered using the Neuromove system. All participants were treated by a licensed occupational therapist, who was trained on a manualized protocol.
Interventions
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transcranial random noise stimulation and functional electrical stimulation facilitated task practice
Participants were randomized to one of the two intervention groups \[transcranial current stimulation (tRNS) and functional electrical stimulation (FES) or FES with sham tRNS\] before pre-intervention testing. After randomization, participants underwent pre-intervention testing, followed by intervention 3 times per week for 6 weeks. Each intervention session lasted for 1 hour, where tRNS or sham-tRNS were delivered concurrently with the FES-facilitated task practice. tRNS or sham-tRNS was delivered for the first 30 minutes. Both tRNS and sham tRNS were delivered by the Starstim system. FES was delivered using the Neuromove system. All participants were treated by a licensed occupational therapist, who was trained on a manualized protocol.
Eligibility Criteria
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Inclusion Criteria
* Episode (1 or more than one) of stroke at least 6 months prior
* Able to follow 3-step commands to rule out severe aphasia
* Unilateral hemiparesis
* Able to speak english
* No active drug or alcohol abuse, schizophrenia, other neurological or medical conditions that would confound results, or refractory depression
* Able to actively flex and extend the more-affected shoulder and elbow at least 30°.
* Able to elicit motor evoked potential in the flexor carpii radialis and extensor carpii radialis muscles of the affected hand.
Exclusion Criteria
* Scores \> 3 on the Amount scale of Motor Activity Log indicating good use of the more-affected hand
* Has ataxia determined via finger-to-nose testing section of the Fugl Meyer Upper Extremity assessment
* Has proprioceptive sensory deficits determined via a score of 2 on the position sense section (section H) of the Fugl Meyer Upper Extremity assessment proprioception
* Excessive pain \> equal to 4 on Visual Analog Scale in the more-affected upper extremity
* Skin lesions on the more-affected upper extremity and scalp
* Individuals with implanted devices that may be affected by electrical stimulation
* Participating in concurrent therapy
* Individuals with seizures
* History of seizures, schizophrenia, Bipolar disorder (type I or II) \[Answer yes to questions 16 and items of the (hypo) maniac module of MINI\], current moderate, severe depression (Scores of \>10 on PHQ-9) and other neurological or medical conditions that could confound results.
* Individuals with refractory depression, which are defined as individuals with severe depressive disorder that are resistant to antidepressants (Scores of \>10 on PHQ-9).
* Current treatment with antipsychotics or benzodiazepines.
* Current treatment with bupropion, which may induce seizure.
* Scores \< 24 on Mini Mental Status Examination
* Pregnant women
18 Years
80 Years
ALL
No
Sponsors
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Zynex Medical, Inc.
INDUSTRY
Neuroelectrics Corporation
INDUSTRY
Amit Sethi
OTHER
Responsible Party
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Amit Sethi
Associate Professor
Principal Investigators
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Amit Sethi, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Neuromotor Recovery and Rehabilitation Lab
Pittsburgh, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PRO13090080
Identifier Type: -
Identifier Source: org_study_id