Skip to main content
Clinical Trials/NCT01749800
NCT01749800
Terminated
N/A

Combining Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors With Attentional Deficits

Spaulding Rehabilitation Hospital1 site in 1 country7 target enrollmentJuly 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
TBI
Sponsor
Spaulding Rehabilitation Hospital
Enrollment
7
Locations
1
Primary Endpoint
Sustained Attention to Response Task
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
November 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Spaulding Rehabilitation Hospital
Responsible Party
Principal Investigator
Principal Investigator

Paolo Bonato

Director, Motion Analysis Lab

Spaulding Rehabilitation Hospital

Eligibility 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
  • 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

Outcomes

Primary Outcomes

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.

Study Sites (1)

Loading locations...

Similar Trials