Trial Outcomes & Findings for Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors (NCT NCT01749800)
NCT ID: NCT01749800
Last Updated: 2017-05-31
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Baseline and end-of-treatment data (up to 2 weeks)
Results posted on
2017-05-31
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
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.
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 Study
STARTED
|
6
|
1
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
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.
|
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.
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.
|
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.
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 Study
not meeting inclusion criteria
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors
Baseline characteristics by cohort
| Measure |
Cognitive Test With/Without GVS
n=6 Participants
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.
|
Armeo Spring +GVS
n=1 Participants
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.
|
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.
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
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
—
|
7 participants
n=4 Participants
|
|
Sustained Attention to Response Task
|
23 percentage error
n=5 Participants
|
20 percentage error
n=7 Participants
|
—
|
22 percentage error
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cognitive Test With/Without GVS
n=3 Participants
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.
|
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.
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.
|
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.
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.
|
|---|---|---|---|
|
Sustained Attention to Response Task
|
26 percentage errors
Interval 7.0 to 45.0
|
—
|
—
|
Adverse Events
Cognitive Test With/Without GVS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Armeo Spring +GVS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Armeo Spring + Sham GVS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cognitive Test With/Without GVS
n=6 participants at risk
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.
|
Armeo Spring +GVS
n=1 participants at risk
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.
|
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.
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.
|
|---|---|---|---|
|
General disorders
Skin damage caused on the stimulation electrodes
|
0.00%
0/6 • Data was collected through study completion (i.e. up to two weeks)
|
0.00%
0/1 • Data was collected through study completion (i.e. up to two weeks)
|
—
0/0 • Data was collected through study completion (i.e. up to two weeks)
|
Other adverse events
| Measure |
Cognitive Test With/Without GVS
n=6 participants at risk
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.
|
Armeo Spring +GVS
n=1 participants at risk
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.
|
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.
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.
|
|---|---|---|---|
|
General disorders
Skin irritation caused by the straps of the robot
|
—
0/0 • Data was collected through study completion (i.e. up to two weeks)
|
0.00%
0/1 • Data was collected through study completion (i.e. up to two weeks)
|
—
0/0 • Data was collected through study completion (i.e. up to two weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place