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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions TBI
Attention Deficits
Motor Impairments
Interventions Device: GVS
Device: Sham GVS
Device: Armeo Spring
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive Test With/Without GVS Armeo Spring +GVS Armeo Spring + Sham GVS
Hide Arm/Group 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.

GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.

Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.

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.

GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.

Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.

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.

Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.

Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.

Period Title: Overall Study
Started 6 [1] 1 [2] 0
Completed 3 0 0
Not Completed 3 1 0
Reason Not Completed
not meeting inclusion criteria             3             0             0
Withdrawal by Subject             0             1             0
[1]
3 subjects did not show significant attention span deficit (required inclusion criterion)
[2]
1 subject showed significant motor impairments but decided to undergo therapy (exclusion criterion)
Arm/Group Title Cognitive Test With/Without GVS Armeo Spring +GVS Armeo Spring + Sham GVS Total
Hide Arm/Group 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.

GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.

Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.

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.

GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.

Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.

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.

Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.

Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.

Total of all reporting groups
Overall Number of Baseline Participants 6 1 0 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 1 participants 0 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
0
   0.0%
Between 18 and 65 years
6
 100.0%
1
 100.0%
0
7
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 1 participants 0 participants 7 participants
Female
0
   0.0%
1
 100.0%
0
1
  14.3%
Male
6
 100.0%
0
   0.0%
0
6
  85.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 1 participants 0 participants 7 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
0
   0.0%
Black or African American
1
  16.7%
0
   0.0%
0
1
  14.3%
White
5
  83.3%
1
 100.0%
0
6
  85.7%
More than one race
0
   0.0%
0
   0.0%
0
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 1 participants 0 participants 7 participants
6 1 7
Sustained Attention to Response Task   [1] 
Mean (Full Range)
Unit of measure:  Percentage error
Number Analyzed 6 participants 1 participants 0 participants 7 participants
23
(7 to 33)
20
(20 to 20)
22
(7 to 33)
[1]
Measure 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.
1.Primary Outcome
Title Sustained Attention to Response Task
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Test With/Without GVS Armeo Spring +GVS Armeo Spring + Sham GVS
Hide Arm/Group 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.

GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.

Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.

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.

GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.

Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.

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.

Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.

Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.

Overall Number of Participants Analyzed 3 0 0
Mean (Full Range)
Unit of Measure: percentage errors
26
(7 to 45)
Time Frame Data was collected through study completion (i.e. up to two weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Test With/Without GVS Armeo Spring +GVS Armeo Spring + Sham GVS
Hide Arm/Group 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.

GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.

Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.

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.

GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.

Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.

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.

Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.

Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.

All-Cause Mortality
Cognitive Test With/Without GVS Armeo Spring +GVS Armeo Spring + Sham GVS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Cognitive Test With/Without GVS Armeo Spring +GVS Armeo Spring + Sham GVS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/1 (0.00%)      0/0    
General disorders       
Skin damage caused on the stimulation electrodes  [1]  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0
Indicates events were collected by systematic assessment
[1]
Delivering a small current through the skin could cause skin damage in the areas covered by the stimulation electrodes. We inspected the skin under the electrodes multiple times during the experiments to monitor the skin status.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cognitive Test With/Without GVS Armeo Spring +GVS Armeo Spring + Sham GVS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/1 (0.00%)      0/0    
General disorders       
Skin irritation caused by the straps of the robot  [1]  0/0  0 0/1 (0.00%)  0 0/0  0
Indicates events were collected by systematic assessment
[1]
The robotic system used to facilitate motor training is equipped with straps that are attached to the arm of the subject. The straps could cause skin irritation. The "cognitive test" group did not use the robotic system. Thus, no subject was at risk.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paolo Bonato
Organization: Spaulding Rehabilitation Hospital
Phone: +1-617-952-6319
EMail: pbonato@partners.org
Layout table for additonal information
Responsible Party: Paolo Bonato, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01749800    
Other Study ID Numbers: 2010-P-000010
First Submitted: December 12, 2012
First Posted: December 17, 2012
Results First Submitted: March 19, 2017
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017