Robots Paired With tDCS in Stroke Recovery

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by North Shore Long Island Jewish Health System
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01726673
First received: October 26, 2012
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Stroke
Device: Transcranial Direct Current Stimulation (tDCS)
Device: Placebo sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Change from baseline in Upper Extremity Fugl Meyer Assessment [ Time Frame: 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Kinematic Data [ Time Frame: 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) ] [ Designated as safety issue: No ]
    Kinematic Data of upper extremity mobility as measure by Interactive Motion Technologies planar (shoulder/elbow) robot and wrist (wrist flexion/extension and pronation/supination) robots during therapy and evaluations

  • Change from baseline in WOLF motor function test [ Time Frame: 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) ] [ Designated as safety issue: No ]
  • Change from baseline in Motor Power Manual Muscle Test [ Time Frame: 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) ] [ Designated as safety issue: No ]
  • Change from baseline in NIH stroke scale [ Time Frame: 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) ] [ Designated as safety issue: No ]
  • Change from baseline in Stroke Impact Scale (SIS) [ Time Frame: 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: September 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tDCS + robotic arm therapy
Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks
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 followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks
Device: Placebo sham

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726673

Contacts
Contact: Bruce T Volpe, MD 516-562-3384 bvolpe1@nshs.edu
Contact: Johanna Chang, MS (516) 562-3646 jchang14@nshs.edu

Locations
United States, New York
Feinstein Institute for Medical Research Recruiting
Manhasset, New York, United States, 11030
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Bruce T Volpe, MD Feinstein Institute for Medical Research
  More Information

Publications:
Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01726673     History of Changes
Other Study ID Numbers: 12-102B
Study First Received: October 26, 2012
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Stroke
Cerebrovascular Accident
Cerebral Stroke
CVA
Robotic therapy
Upper extremity recovery
tDCS
Non-invasive brain stimulation

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

ClinicalTrials.gov processed this record on July 28, 2014