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Robots Paired With tDCS in Stroke Recovery

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ClinicalTrials.gov Identifier: NCT01726673
Recruitment Status : Completed
First Posted : November 15, 2012
Results First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce Volpe, Northwell Health

Brief Summary:
The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.

Condition or disease Intervention/treatment Phase
Stroke Device: Transcranial Direct Current Stimulation (tDCS) Device: Placebo sham Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation Paired With Robotic Arm Therapy on Recovery of Upper Extremity Motor Function in Stroke Patients
Actual Study Start Date : September 2012
Actual Primary Completion Date : January 2018
Actual Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: 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)
Device: Transcranial Direct Current Stimulation (tDCS)
Other Names:
  • tDCS
  • Low intensity transcranial DC stimulator
  • Soterix 1x1

Placebo Comparator: 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)
Device: Placebo sham
Other Name: tDCS sham




Primary Outcome Measures :
  1. Median Change in Upper Extremity Fugl Meyer Assessment Score [ Time Frame: baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention) ]
    The median change in Upper Extremity Fugl-Meyer Score was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.


Secondary Outcome Measures :
  1. Median Change in WOLF Motor Function Test (WMFT) [ Time Frame: baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention) ]
    The median change in performance time for the WOLF motor function test was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total WOLF motor function timed score is reported here in seconds, with a range 0-1800 seconds, and with lower values indicating faster completion of task and better functional status.

  2. Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC) [ Time Frame: 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) ]
    The median change in Motor Power Manual Muscle Test Score for the upper extremity was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Motor Power Manual Muscle Test Score is reported here, with a range 0-100 points, and with higher values indicating better functional status.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • 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:

  • Botox treatment within 6 weeks of enrollment
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726673


Locations
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United States, New York
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Bruce T Volpe, MD Feinstein Institute for Medical Research
  Study Documents (Full-Text)

Documents provided by Bruce Volpe, Northwell Health:

Publications:
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Responsible Party: Bruce Volpe, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT01726673     History of Changes
Other Study ID Numbers: 12-102B
First Posted: November 15, 2012    Key Record Dates
Results First Posted: August 16, 2018
Last Update Posted: August 16, 2018
Last Verified: June 2018

Keywords provided by Bruce Volpe, Northwell Health:
Stroke
Cerebrovascular Accident
Cerebral Stroke
CVA
Robotic therapy
Upper extremity recovery
tDCS
Non-invasive brain stimulation

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases