Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2012-09-30
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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tDCS + robotic arm therapy
Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)
Transcranial Direct Current Stimulation (tDCS)
tDCS sham + robotic arm therapy
Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)
Placebo sham
Interventions
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Transcranial Direct Current Stimulation (tDCS)
Placebo sham
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
* Cognitive function sufficient enough to understand experiments and follow instructions
* Fugl-Meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)
Exclusion Criteria
* Fixed contraction of the affected limb
* Complete flaccid paralysis of the affected limb
* History of hemorrhagic stroke
* Ongoing use of CNS active medications
* Ongoing use of psychoactive medications
* Presence of additional potential tDCS/TMS risk factors including damaged skin at site of stimulation, presence of a magnetically/mechanically active implant, metal in the head, family history of epilepsy, and personal history of seizures
18 Years
ALL
No
Sponsors
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Northwell Health
OTHER
Responsible Party
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Bruce Volpe
Principal Investigator
Principal Investigators
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Bruce T Volpe, MD
Role: PRINCIPAL_INVESTIGATOR
Feinstein Institute for Medical Research
Locations
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Feinstein Institute for Medical Research
Manhasset, New York, United States
Countries
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References
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Edwards DJ, Krebs HI, Rykman A, Zipse J, Thickbroom GW, Mastaglia FL, Pascual-Leone A, Volpe BT. Raised corticomotor excitability of M1 forearm area following anodal tDCS is sustained during robotic wrist therapy in chronic stroke. Restor Neurol Neurosci. 2009;27(3):199-207. doi: 10.3233/RNN-2009-0470.
Moretti CB, Hamilton T, Edwards DJ, Peltz AR, Chang JL, Cortes M, Delbe ACB, Volpe BT, Krebs HI. Robotic Kinematic measures of the arm in chronic Stroke: part 2 - strong correlation with clinical outcome measures. Bioelectron Med. 2021 Dec 29;7(1):21. doi: 10.1186/s42234-021-00082-8.
Moretti CB, Edwards DJ, Hamilton T, Cortes M, Peltz AR, Chang JL, Delbem ACB, Volpe BT, Krebs HI. Robotic Kinematic measures of the arm in chronic Stroke: part 1 - Motor Recovery patterns from tDCS preceding intensive training. Bioelectron Med. 2021 Dec 29;7(1):20. doi: 10.1186/s42234-021-00081-9.
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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12-102B
Identifier Type: -
Identifier Source: org_study_id
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