Attention Deficits, Motor Impairments, TBI
Conditions
Keywords
TBI, Attention deficits, Upper extremity weakness
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.
Interventions
DEVICEGVS
A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
DEVICESham GVS
Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.
DEVICEArmeo Spring
A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Attention to Response Task | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 1 |
| 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. | 0 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | not meeting inclusion criteria | 3 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Cognitive Test With/Without GVS | Armeo Spring +GVS | Armeo Spring + Sham GVS | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 1 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 1 Participants | 0 Participants | 6 Participants |
| Region of Enrollment United States | 6 participants | 1 participants | — | 7 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 0 Participants | 0 Participants | 6 Participants |
| Sustained Attention to Response Task | 23 percentage error | 20 percentage error | — | 22 percentage error |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 6 | 0 / 1 | 0 / 0 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cognitive Test With/Without GVS | Sustained Attention to Response Task | 26 percentage errors |