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Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors

This study has been terminated.
(Lack of funding)
Sponsor:
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01749800
First received: December 12, 2012
Last updated: April 30, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
TBI Attention Deficits Motor Impairments Device: GVS Device: Sham GVS Device: Armeo Spring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Paolo Bonato, Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 7
Study Start Date: July 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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: 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
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.
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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
  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

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Paolo Bonato, PhD Spaulding Rehabilitation Hospital
  More Information

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
Results First Received: March 19, 2017
Last Updated: April 30, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Paolo Bonato, Spaulding Rehabilitation Hospital:
TBI
Attention deficits
Upper extremity weakness

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

ClinicalTrials.gov processed this record on September 21, 2017