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Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors

Primary Purpose

TBI, Attention Deficits, Motor Impairments

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GVS
Sham GVS
Armeo Spring
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TBI focused on measuring TBI, Attention deficits, Upper extremity weakness

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Cognitive test with/without GVS

Armeo Spring +GVS

Armeo Spring + sham GVS

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Sustained Attention to Response Task
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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2012
Last Updated
April 30, 2017
Sponsor
Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01749800
Brief Title
Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors
Official Title
Combining Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors With Attentional Deficits
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI, Attention Deficits, Motor Impairments
Keywords
TBI, Attention deficits, Upper extremity weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive test with/without GVS
Arm Type
Experimental
Arm Description
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.
Arm Title
Armeo Spring +GVS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Armeo Spring + sham GVS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
GVS
Other Intervention Name(s)
Device: Model 2200 Analog Stimulus Isolator, Produce by: A-M Systems, Inc., WA, USA
Intervention Description
A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Intervention Type
Device
Intervention Name(s)
Sham GVS
Other Intervention Name(s)
Device: Model 2200 Analog Stimulus Isolator, Produce by: A-M Systems, Inc., WA, USA
Intervention Description
Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.
Intervention Type
Device
Intervention Name(s)
Armeo Spring
Other Intervention Name(s)
Device: Armeo Spring, Produced by: Hocoma
Intervention Description
A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.
Primary Outcome Measure Information:
Title
Sustained Attention to Response Task
Description
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.
Time Frame
Baseline and end-of-treatment data (up to 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Bonato, PhD
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors

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