An interventional study of GVS and Sham GVS in TBI, Attention Deficits and Motor Impairments, sponsored by Spaulding Rehabilitation Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-31.
Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Treatment
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 7 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Spaulding Rehabilitation Hospital is the lead sponsor of 114 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
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 · Device: Sham 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 · Device: Armeo Spring
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 · Device: Armeo Spring
A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Also known as: Device: Model 2200 Analog Stimulus Isolator, Produce by: A-M Systems, Inc., WA, USA
Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.
Also known as: Device: Model 2200 Analog Stimulus Isolator, Produce by: A-M Systems, Inc., WA, USA
A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.
Also known as: Device: Armeo Spring, Produced by: Hocoma
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.
Time frame: Baseline and end-of-treatment data (up to 2 weeks)
| Milestone | Cognitive Test With/Without GVS | Armeo Spring +GVS | Armeo Spring + Sham GVS |
|---|---|---|---|
| Started | 6 | 1 | 0 |
| Completed | 3 | 0 | 0 |
| Not completed | 3 | 1 | 0 |
| Withdrew: Not meeting inclusion criteria | 3 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
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.
| percentage errors | Cognitive Test With/Without GVS | Armeo Spring +GVS | Armeo Spring + Sham GVS |
|---|---|---|---|
| Sustained Attention to Response Task | 26 (7 to 45) | — | — |
Collected over Data was collected through study completion (i.e. up to two weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive Test With/Without GVS | — | 0/6 (0%) | — |
| Armeo Spring +GVS | — | 0/1 (0%) | 0/1 (0%) |
| Armeo Spring + Sham GVS | — | — | — |
| Event | Cognitive Test With/Without GVS | Armeo Spring +GVS | Armeo Spring + Sham GVS |
|---|---|---|---|
| Skin damage caused on the stimulation electrodesGeneral disorders | 0/6 | 0/1 | — |
| Event | Cognitive Test With/Without GVS | Armeo Spring +GVS | Armeo Spring + Sham GVS |
|---|---|---|---|
| Skin irritation caused by the straps of the robotGeneral disorders | — | 0/1 | — |
| Age, Categorical(Participants) | Cognitive Test With/Without GVS | Armeo Spring +GVS | Armeo Spring + Sham GVS | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 1 | 0 | 7 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Cognitive Test With/Without GVS | Armeo Spring +GVS | Armeo Spring + Sham GVS | Total |
|---|---|---|---|---|
| Female | 0 | 1 | 0 | 1 |
| Male | 6 | 0 | 0 | 6 |
| Race (NIH/OMB)(Participants) | Cognitive Test With/Without GVS | Armeo Spring +GVS | Armeo Spring + Sham GVS | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 |
| White | 5 | 1 | 0 | 6 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cognitive Test With/Without GVS | Armeo Spring +GVS | Armeo Spring + Sham GVS | Total |
|---|---|---|---|---|
| United States | 6 | 1 | — | 7 |
| Sustained Attention to Response Task(percentage error) | Cognitive Test With/Without GVS | Armeo Spring +GVS | Armeo Spring + Sham GVS | Total |
|---|---|---|---|---|
| Mean | 23 (7 to 33) | 20 (20 to 20) | — | 22 (7 to 33) |
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Spaulding Rehabilitation Hospital