Combining Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors With Attentional Deficits (GVS TBI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Spaulding Rehabilitation Hospital
Sponsor:
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01749800
First received: December 12, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

The overall goal of the proposed project is: (1) to perform a preliminary study to determine optimal galvanic vestibular stimulation (GVS) settings based on performance of one cognitive test of attention, and (2) to gather preliminary evidence of the effects of GVS in combination with computer-based attention training and motor training performed using a robotic system designed for rehabilitation, in a small cohort of TBI survivors (20 subjects).


Condition Intervention
TBI
Attention Deficits
Device: GVS
Device: Sham GVS
Device: Armeo Spring
Other: Computer-based attention games

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Combining Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors With Attentional Deficits

Resource links provided by NLM:


Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Change in Jebsen-Taylor Hand Function Test scores from Baseline [ Time Frame: Baseline, week 4, 2 weeks follow-up (week 6) ] [ Designated as safety issue: No ]
  • Changes in Box and Block Test scores from Baseline [ Time Frame: Baseline, week 4, 2 weeks follow-up (week 6) ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continous mild GVS
Each subject's stimulation threshold will be determined based on the best performance during attention tests
Device: GVS
Other Names:
  • Device: Model 2200 Analog Stimulus Isolator
  • Produce by: A-M Systems, Inc., WA, USA
Device: Armeo Spring
Other Names:
  • Device: Armeo Spring
  • Produced by: Hocoma
Other: Computer-based attention games
Sham Comparator: Sham GVS
Sham galvanic vestibular stimulation
Device: Sham GVS
Other Names:
  • Device: Model 2200 Analog Stimulus Isolator
  • Produce by: A-M Systems, Inc., WA, USA
Device: Armeo Spring
Other Names:
  • Device: Armeo Spring
  • Produced by: Hocoma
Other: Computer-based attention games

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Sufficient voluntary movement and range of motion in their upper extremity to use the robotic arm system (ARMEO)

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
  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: NCT01749800

Contacts
Contact: Catherine Adans-Dester, PT 617-952-6321 cadans-dester@partners.org

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Catherine Adans-Dester    617-952-6321    cadans-dester@partners.org   
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Paolo Bonato, PhD Spaulding Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Paolo Bonato, Director, Motion Analysis Lab, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01749800     History of Changes
Other Study ID Numbers: 2010-P-000010
Study First Received: December 12, 2012
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
TBI
Attention deficits
upper extremity weakness

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Brain Injuries
Attention Deficit and Disruptive Behavior Disorders
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014