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Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01749800
Recruitment Status : Terminated (Lack of funding)
First Posted : December 17, 2012
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital

Tracking Information
First Submitted Date  ICMJE December 12, 2012
First Posted Date  ICMJE December 17, 2012
Results First Submitted Date  ICMJE March 19, 2017
Results First Posted Date  ICMJE May 31, 2017
Last Update Posted Date May 31, 2017
Study Start Date  ICMJE July 2011
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2017)
Sustained Attention to Response Task [ Time Frame: Baseline and end-of-treatment data (up to 2 weeks) ]
Subjects are presented with objects (one at the time) on a computer screen and are instructed to press a key on the keyboard according to the characteristics of the object shown on the computer screen. Error rates are measured as percentage of erroneous key selections.
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
  • Change in Jebsen-Taylor Hand Function Test scores from Baseline [ Time Frame: Baseline, week 4, 2 weeks follow-up (week 6) ]
  • Changes in Box and Block Test scores from Baseline [ Time Frame: Baseline, week 4, 2 weeks follow-up (week 6) ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors
Official Title  ICMJE Combining Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors With Attentional Deficits
Brief Summary The overall goal of the proposed project is to perform a preliminary study to assess the potential effects of galvanic vestibular stimulation (GVS) on the outcomes of a cognitive test of attention and the outcomes of robot-assisted upper-limb rehabilitation.
Detailed Description We plan to explore the use of GVS on the severity of attention span deficits and motor training delivered using a spring-based robot. We intend to carry out the study in a small cohort of traumatic brain injury (TBI) survivors (20 subjects). Subjects with attention span deficits but no significant motor impairments will solely undergo a cognitive test of attention with/without GVS. Subjects with both attention span deficits and significant motor impairments will undergo a cognitive test of attention and robot-assisted upper-limb rehabilitation with/without GVS.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • TBI
  • Attention Deficits
  • Motor Impairments
Intervention  ICMJE
  • Device: GVS
    A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
    Other Names:
    • Device: Model 2200 Analog Stimulus Isolator
    • Produce by: A-M Systems, Inc., WA, USA
  • Device: Sham GVS
    Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.
    Other Names:
    • Device: Model 2200 Analog Stimulus Isolator
    • Produce by: A-M Systems, Inc., WA, USA
  • Device: Armeo Spring
    A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.
    Other Names:
    • Device: Armeo Spring
    • Produced by: Hocoma
Study Arms  ICMJE
  • Experimental: Cognitive test with/without GVS
    Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.
    Interventions:
    • Device: GVS
    • Device: Sham GVS
  • Active Comparator: Armeo Spring +GVS
    Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.
    Interventions:
    • Device: GVS
    • Device: Armeo Spring
  • Sham Comparator: Armeo Spring + sham GVS
    Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.
    Interventions:
    • Device: Sham GVS
    • Device: Armeo Spring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 20, 2014)
7
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2012)
20
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Moderate to severe traumatic brain injury involving cognitive and/or motor deficits.
  • Neurological injury >1 year prior to study enrollment
  • Significant attention deficit
  • For subjects with motor deficits (arms 2 and 3), sufficient voluntary movement and range of motion in the most-affected upper extremity to use the robotic arm system (Armeo Spring)

Exclusion Criteria:

  • Pregnancy
  • History of seizures within 6 months of study enrollment
  • Major depression
  • Cognitive impairment that may interfere with understanding instructions
  • Severe limitations of upper extremity range of motion
  • Agitation
  • Other major neurological or psychiatric diseases
  • Participation in other forms of therapy/ intervention for upper extremity motor recovery
  • End-stage liver, kidney, cardiac or pulmonary disease
  • A terminal medical diagnosis with survival <1 year
  • History of drug or alcohol abuse in the last 3 years
  • Adjustment of, or plan to adjust, psychoactive medications within the preceding 1 month, or within the study period.
  • Current participation in another interventional trial targeting TBI
  • Previous GVS treatment
  • Contraindications to GVS such as implants
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01749800
Other Study ID Numbers  ICMJE 2010-P-000010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Paolo Bonato, Spaulding Rehabilitation Hospital
Study Sponsor  ICMJE Spaulding Rehabilitation Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paolo Bonato, PhD Spaulding Rehabilitation Hospital
PRS Account Spaulding Rehabilitation Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP